Trial Outcomes & Findings for A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD) (NCT NCT00524537)
NCT ID: NCT00524537
Last Updated: 2017-01-24
Results Overview
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below.
Recruitment status
COMPLETED
Target enrollment
5025 participants
Primary outcome timeframe
Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Results posted on
2017-01-24
Participant Flow
A total of 6 participants less than 18 years of age were enrolled in the study. Participants were permitted to re-enroll after discontinuing the study. Of the 2811 participants who discontinued study, 339 re-enrolled in the study; 102 participants discontinued from the study after re-enrollment.
Participant milestones
| Measure |
Adalimumab (Humira) Treatment
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Overall Study
STARTED
|
5025
|
|
Overall Study
Discontinued
|
2811
|
|
Overall Study
Re-enrolled
|
339
|
|
Overall Study
Discontinued After Re-enrollment
|
102
|
|
Overall Study
COMPLETED
|
2451
|
|
Overall Study
NOT COMPLETED
|
2574
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
Baseline characteristics by cohort
| Measure |
Adalimumab (Humira) Treatment
n=5025 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2869 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2156 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).Population: All Treated Population: All participants who received at least 1 injection of Humira in the registry
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=5025 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
AE Leading to Discontinuation of Study Drug
|
596 Participants
|
|
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
Any SAE
|
1853 Participants
|
|
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
Any AE Leading to Death
|
43 Participants
|
|
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
Any AE
|
2392 Participants
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements.
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=2166 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 12 (N=1712)
|
4.98 units on a scale
Standard Deviation 12.335
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 24 (N=1319)
|
4.20 units on a scale
Standard Deviation 13.397
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 36 (N=1712)
|
5.01 units on a scale
Standard Deviation 12.994
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 48 (N=969)
|
5.51 units on a scale
Standard Deviation 13.466
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 60 (N=837)
|
5.45 units on a scale
Standard Deviation 13.211
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
Change from Baseline to Month 72 (N=748)
|
5.41 units on a scale
Standard Deviation 12.768
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements.
The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=3897 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 12 (N=3335)
|
-1.63 units on a scale
Standard Deviation 4.961
|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 24 (N=2856)
|
-1.63 units on a scale
Standard Deviation 5.108
|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 48 (N=2403)
|
-1.91 units on a scale
Standard Deviation 5.169
|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 60 (N=2162)
|
-2.00 units on a scale
Standard Deviation 5.242
|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 72 (N=1983)
|
-2.08 units on a scale
Standard Deviation 5.602
|
|
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
Change from Baseline to Month 36 (N=2629)
|
-1.84 units on a scale
Standard Deviation 5.143
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.
Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100\*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=1065 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 36 (N=507)
|
-5.62 percentage of work time missed
Standard Deviation 29.649
|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 48 (N=436)
|
-3.93 percentage of work time missed
Standard Deviation 31.884
|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 60 (N=368)
|
-3.22 percentage of work time missed
Standard Deviation 29.622
|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 72 (N=303)
|
-3.89 percentage of work time missed
Standard Deviation 26.865
|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 12 (N=829)
|
-4.92 percentage of work time missed
Standard Deviation 26.881
|
|
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Change from Baseline to Month 24 (N=612)
|
-3.02 percentage of work time missed
Standard Deviation 26.607
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.
Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=1183 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 12 (N=914)
|
-8.00 percentage of impairment while working
Standard Deviation 29.602
|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 24 (N=697)
|
-7.04 percentage of impairment while working
Standard Deviation 31.666
|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 36 (N=577)
|
-9.84 percentage of impairment while working
Standard Deviation 30.570
|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 48 (N=493)
|
-8.09 percentage of impairment while working
Standard Deviation 33.611
|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 60 (N=418)
|
-8.21 percentage of impairment while working
Standard Deviation 30.130
|
|
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 72 (N=361)
|
-8.03 percentage of impairment while working
Standard Deviation 29.472
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.
The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to CD + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=1061 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 60 (N=365)
|
-8.14 percentage of overall work impairment
Standard Deviation 34.696
|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 72 (N=300)
|
-9.33 percentage of overall work impairment
Standard Deviation 34.631
|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 12 (N=821)
|
-9.48 percentage of overall work impairment
Standard Deviation 32.976
|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 24 (N=605)
|
-7.95 percentage of overall work impairment
Standard Deviation 35.798
|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 36 (N=498)
|
-11.78 percentage of overall work impairment
Standard Deviation 34.886
|
|
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 48 (N=435)
|
-9.15 percentage of overall work impairment
Standard Deviation 36.957
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.
Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=2110 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 60 (N=817)
|
-10.78 percentage of activity impairment
Standard Deviation 31.787
|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 24 (N=1286)
|
-9.75 percentage of activity impairment
Standard Deviation 33.244
|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 48 (N=944)
|
-10.14 percentage of activity impairment
Standard Deviation 33.063
|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 12 (N=1665)
|
-10.93 percentage of activity impairment
Standard Deviation 30.548
|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 36 (N=1095)
|
-10.07 percentage of activity impairment
Standard Deviation 32.705
|
|
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Change from Baseline to Month 72 (N=718)
|
-11.13 percentage of activity impairment
Standard Deviation 29.533
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office.
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=5025 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Baseline (N=97)
|
2.79 number of visits at physician's office
Standard Deviation 2.947
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 12 (N=780)
|
1.95 number of visits at physician's office
Standard Deviation 2.039
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 24 (N=1042)
|
2.19 number of visits at physician's office
Standard Deviation 2.079
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 36 (N=1003)
|
2.38 number of visits at physician's office
Standard Deviation 3.242
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 48 (N=869)
|
2.38 number of visits at physician's office
Standard Deviation 2.326
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 60 (N=798)
|
2.39 number of visits at physician's office
Standard Deviation 2.084
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
Month 72 (N=711)
|
2.32 number of visits at physician's office
Standard Deviation 2.051
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room.
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=177 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 12 (N=143)
|
1.28 number of visits at emergency room
Standard Deviation 0.883
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Baseline (N=8)
|
1.13 number of visits at emergency room
Standard Deviation 0.354
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 24 (N=162)
|
1.25 number of visits at emergency room
Standard Deviation 0.558
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 36 (N=134)
|
1.49 number of visits at emergency room
Standard Deviation 0.865
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 48 (N=131)
|
1.39 number of visits at emergency room
Standard Deviation 0.686
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 60 (N=124)
|
1.41 number of visits at emergency room
Standard Deviation 0.817
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
Month 72 (N=97)
|
1.41 number of visits at emergency room
Standard Deviation 0.826
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for "total days in hospital" and at least one admission to hospital.
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint..
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=5025 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 48 (N=180)
|
1.54 number of admissions to hospital
Standard Deviation 2.037
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 60 (N=197)
|
1.60 number of admissions to hospital
Standard Deviation 1.215
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Baseline (N=10)
|
1.30 number of admissions to hospital
Standard Deviation 0.675
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 12 (N=230)
|
1.29 number of admissions to hospital
Standard Deviation 0.780
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 24 (N=255)
|
1.26 number of admissions to hospital
Standard Deviation 0.585
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 36 (N=229)
|
1.41 number of admissions to hospital
Standard Deviation 0.793
|
|
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
Month 72 (N=180)
|
1.83 number of admissions to hospital
Standard Deviation 3.115
|
SECONDARY outcome
Timeframe: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 MonthsPopulation: All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for "total days in hospital".
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint.
Outcome measures
| Measure |
Adalimumab (Humira) Treatment
n=260 Participants
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 12 (N=230)
|
8.19 total days in hospital
Standard Deviation 9.801
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 24 (N=255)
|
9.17 total days in hospital
Standard Deviation 11.753
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 36 (N=229)
|
9.75 total days in hospital
Standard Deviation 19.474
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 60 (N=195)
|
9.03 total days in hospital
Standard Deviation 12.997
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Baseline (N=10)
|
5.80 total days in hospital
Standard Deviation 3.259
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 48 (N=180)
|
8.37 total days in hospital
Standard Deviation 10.011
|
|
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
Month 72 (N=180)
|
9.27 total days in hospital
Standard Deviation 13.158
|
Adverse Events
Adalimumab (Humira) Treatment
Serious events: 1853 serious events
Other events: 958 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab (Humira) Treatment
n=5025 participants at risk
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Hepatobiliary disorders
HEPATORENAL SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.50%
25/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
AUTOIMMUNE HAEMOLYTIC ANAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
BONE MARROW OEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
IMMUNE THROMBOCYTOPENIC PURPURA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
SICKLE CELL ANAEMIA WITH CRISIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
BRADYARRHYTHMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
BRADYCARDIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CORONARY ARTERY EMBOLISM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
PALPITATIONS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
PERICARDITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
TACHYCARDIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Congenital, familial and genetic disorders
VITELLO-INTESTINAL DUCT REMNANT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
GOITRE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
BLEPHARITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
CORNEAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
EPISCLERITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
RETINOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
SCLERITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
ULCERATIVE KERATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.20%
10/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA OBSTRUCTIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL MASS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
61/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL WALL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABNORMAL FAECES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
1.7%
84/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL SPHINCTER ATONY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL STENOSIS
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANOGENITAL DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL DISORDER
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL STENOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ASCITES
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
AUTOIMMUNE PANCREATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COELIAC ARTERY COMPRESSION SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COLITIS
|
0.34%
17/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COLON DYSPLASIA
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
12.1%
606/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DEFAECATION URGENCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.48%
24/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIEULAFOY'S VASCULAR MALFORMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DUODENAL STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.30%
15/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTEROCOLONIC FISTULA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.44%
22/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FAECALOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FEMORAL HERNIA STRANGULATED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FISTULA OF SMALL INTESTINE
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FUNCTIONAL GASTROINTESTINAL DISORDER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRIC FISTULA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HERNIAL EVENTRATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
1.9%
94/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ILEUS
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INCARCERATED UMBILICAL HERNIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INFLAMMATORY BOWEL DISEASE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INFREQUENT BOWEL MOVEMENTS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTERNAL HERNIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL DILATATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL FIBROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL FISTULA
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL MASS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL MUCOSAL HYPERTROPHY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
2.5%
127/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL POLYP
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.88%
44/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMATOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTUSSUSCEPTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
JEJUNAL PERFORATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
JEJUNAL STENOSIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LARGE INTESTINAL STENOSIS
|
0.82%
41/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LOCALISED INTRAABDOMINAL FLUID COLLECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
MEGACOLON
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
MELAENA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
MESENTERIC VEIN THROMBOSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
NARCOTIC BOWEL SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
NAUSEA
|
0.32%
16/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGEAL FISTULA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGEAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGEAL OBSTRUCTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGEAL PERFORATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OMENTAL INFARCTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ORAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PANCREATIC PSEUDOCYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PANCREATITIS NECROTISING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PANCREATITIS RELAPSING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PAPILLA OF VATER STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PHARYNGO-OESOPHAGEAL DIVERTICULUM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
POUCHITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PROCTITIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PSEUDOPOLYPOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL DISCHARGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL PERFORATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL SPASM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL STENOSIS
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SHORT-BOWEL SYNDROME
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.6%
131/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
|
0.42%
21/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL ULCER HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SUBILEUS
|
1.4%
68/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
VOLVULUS OF SMALL BOWEL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
VOMITING
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
ASTHENIA
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CATHETER SITE DISCHARGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CHEST PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CHILLS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DEATH
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DEVICE DISLOCATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DEVICE ISSUE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DEVICE LEAKAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DISCOMFORT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG EFFECT DECREASED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG INTOLERANCE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
FACE OEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
FIBROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
GAIT DISTURBANCE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
HYPERTHERMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
IMPAIRED HEALING
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
LOCAL SWELLING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
LOCALISED OEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
MALAISE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
MASS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
NO THERAPEUTIC RESPONSE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
OEDEMA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PYREXIA
|
0.54%
27/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
SENSATION OF FOREIGN BODY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
SUDDEN DEATH
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
TREATMENT FAILURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLANGITIS CHRONIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLANGITIS SCLEROSING
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLELITHIASIS OBSTRUCTIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CIRRHOSIS ALCOHOLIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
GALLBLADDER DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC NECROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATITIS ALCOHOLIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATOCELLULAR INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
NODULAR REGENERATIVE HYPERPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
AMYLOIDOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
TRANSPLANT REJECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.86%
43/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.38%
19/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS JAW
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS LIMB
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ANAL ABSCESS
|
2.4%
119/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ANAL FISTULA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
APPENDICITIS
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BACTERAEMIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BARTHOLIN'S ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BARTHOLINITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BILIARY SEPSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BRAIN ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BRONCHITIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CANDIDA PNEUMONIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CELLULITIS
|
0.38%
19/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CHOLANGITIS INFECTIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CHOLECYSTITIS INFECTIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CYSTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CYTOMEGALOVIRUS COLITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DISSEMINATED TUBERCULOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DIVERTICULITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EAR INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ENDOCARDITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ENTEROCOCCAL BACTERAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ERYSIPELAS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FALLOPIAN TUBE ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FUNGAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FUNGAL PERITONITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GAS GANGRENE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS
|
0.52%
26/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL ABSCESS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL HERPES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GROIN ABSCESS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HAEMATOMA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HELICOBACTER GASTRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HEPATITIS C
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES OESOPHAGITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES OPHTHALMIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES ZOSTER
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES ZOSTER OTICUS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HIV INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
IMPETIGO
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INCISION SITE ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTED CYST
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTION PARASITIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFLUENZA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
KLEBSIELLA BACTERAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LEGIONELLA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LISTERIOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LUNG ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LUNG INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LYMPHADENITIS BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MASTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MASTOIDITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MUSCLE ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OPHTHALMIC HERPES SIMPLEX
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL HERPES
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORCHITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OTITIS MEDIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OVERGROWTH BACTERIAL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PAROTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PELVIC ABSCESS
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERINEAL ABSCESS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERIORBITAL CELLULITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERITONITIS
|
0.32%
16/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERIUMBILICAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERTUSSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PILONIDAL CYST
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA
|
0.66%
33/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA CHLAMYDIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA PSEUDOMONAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POST PROCEDURAL SEPSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.20%
10/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PSOAS ABSCESS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.42%
21/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RENAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RETROPERITONEAL ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RICKETTSIOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SALMONELLOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SALPINGITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SCROTAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SEPSIS
|
0.38%
19/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SIALOADENITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SINUSITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SKIN CANDIDA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STOMA SITE ABSCESS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STREPTOCOCCAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SUBDIAPHRAGMATIC ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SUPERINFECTION BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TONSILLITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TORULOPSIS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TRACHEITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TUBERCULOSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TUBERCULOSIS GASTROINTESTINAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TUBO-OVARIAN ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
UROSEPSIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VAGINAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VARICELLA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VARICELLA ZOSTER PNEUMONIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VIRAL INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VULVAL ABSCESS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VULVAL CELLULITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
WOUND INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC COMPLICATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC FISTULA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC STENOSIS
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC ULCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC ULCER HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
COLON INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FALL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL DISORDER POSTOPERATIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.32%
16/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
INTESTINAL ANASTOMOSIS COMPLICATION
|
0.46%
23/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
NERVE INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PROCEDURAL INTESTINAL PERFORATION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
SCAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
STOMA SITE INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
SUTURE RELATED COMPLICATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
UTERINE RUPTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WOUND DECOMPOSITION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WOUND SECRETION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
BACTERIAL TEST POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
CLOSTRIDIUM TEST POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
CSF CULTURE POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
CULTURE URINE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
PROTEIN TOTAL ABNORMAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
WEIGHT DECREASED
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.20%
10/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
OBESITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHROPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.44%
22/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FISTULA DISCHARGE
|
0.42%
21/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE NONUNION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC COMPRESSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
POLYCHONDRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SERONEGATIVE ARTHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACROCHORDON
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOID CYSTIC CARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER STAGE I, WITHOUT CANCER IN SITU
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOID TUMOUR
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOID TUMOUR OF THE APPENDIX
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOLANGIOCARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER METASTATIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER STAGE I
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOCARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE IV
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GALLBLADDER ADENOCARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GALLBLADDER CANCER METASTATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PAPILLOMA OF BREAST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRAOCULAR MELANOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEIOMYOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA METASTATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC LYMPHOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYCOSIS FUNGOIDES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA METASTATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL ADENOCARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEMINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER METASTATIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL INTESTINE ADENOCARCINOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL INTESTINE CARCINOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE CERVIX
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE VULVA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-CELL LYMPHOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTIS CANCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER STAGE 0
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
ARACHNOIDITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
ATAXIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CAROTID ARTERY ANEURYSM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBRAL ARTERY EMBOLISM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBRAL CYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBROSPINAL FLUID LEAKAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DEMYELINATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DIZZINESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DYSARTHRIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
EPILEPSY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
HEADACHE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
HEMIPARESIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
INTERCOSTAL NEURALGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
INTRACRANIAL VENOUS SINUS THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
NEUROLOGICAL DECOMPENSATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
OPTIC NEURITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
PARAESTHESIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SEIZURE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SYNCOPE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
UPPER MOTOR NEURONE LESION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.46%
23/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS COMPLETE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
COMPLICATION OF DELIVERY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
DELAYED DELIVERY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DEATH
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
HYDROPS FOETALIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE RUPTURE OF MEMBRANES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED PREGNANCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
RUPTURED ECTOPIC PREGNANCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
STILLBIRTH
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
DEPRESSION
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
EATING DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
OBSESSIVE-COMPULSIVE DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
DYSURIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.50%
25/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
OBSTRUCTIVE UROPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
PELVI-URETERIC OBSTRUCTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URGE INCONTINENCE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
BARTHOLIN'S CYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
BREAST DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
BREAST HYPERPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
CERVIX DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
CERVIX INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
ENDOMETRIAL THICKENING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.44%
22/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
GENITAL PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
INFERTILITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
OEDEMA GENITAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PELVIC ADHESIONS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PELVIC FLUID COLLECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PERINEAL FISTULA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PERINEAL PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VAGINAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VAGINAL FISTULA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VARICOCELE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOLITHIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL OBSTRUCTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL TURBINATE ABNORMALITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY SARCOIDOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS LUPUS ERYTHEMATOSUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS PSORIASIFORM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
GUTTATE PSORIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HENOCH-SCHONLEIN PURPURA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PYODERMA GANGRENOSUM
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH FOLLICULAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
COLOSTOMY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
DRUG DETOXIFICATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
INTESTINAL ANASTOMOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
AORTIC DISSECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
BEHCET'S SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
EMBOLISM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HYPERTENSION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HYPOTENSION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
PHLEBITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
POLYARTERITIS NODOSA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
VASCULITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
Other adverse events
| Measure |
Adalimumab (Humira) Treatment
n=5025 participants at risk
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
|
|---|---|
|
Infections and infestations
MASTITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
ABDOMINAL LYMPHADENOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.60%
30/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
HYPERGAMMAGLOBULINAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.32%
16/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
MACROCYTOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
SPLENIC VEIN THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
EXTRASYSTOLES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
PALPITATIONS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Cardiac disorders
TACHYCARDIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Congenital, familial and genetic disorders
HEREDITARY FRUCTOSE INTOLERANCE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Congenital, familial and genetic disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
BLEPHARITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
CHALAZION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
DRY EYE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
EPISCLERITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
EYE INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
IRIDOCYCLITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
IRITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
PUNCTATE KERATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
SCLERITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
VISION BLURRED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL MASS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.60%
30/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL PRURITUS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL STENOSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL DISCOMFORT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ANORECTAL SWELLING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CHEILITIS GRANULOMATOSA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COELIAC DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
COLITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
1.6%
81/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DENTAL DISCOMFORT
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.52%
26/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DUODENAL STENOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DUODENITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTEROCOLONIC FISTULA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FISTULA OF SMALL INTESTINE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HERNIAL EVENTRATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL FISTULA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
JEJUNAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LARGE INTESTINAL STENOSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LIP SWELLING
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
LOCALISED INTRAABDOMINAL FLUID COLLECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
MUCOUS STOOLS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
NAUSEA
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
OESOPHAGEAL FOOD IMPACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ORAL LICHEN PLANUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
ORAL MUCOSAL ERUPTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PALATAL DYSPLASIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PERIANAL ERYTHEMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
PROCTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL LESION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL STENOSIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
RECTAL TENESMUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
TONGUE DISCOLOURATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
TOOTH LOSS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Gastrointestinal disorders
VOMITING
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
APPLICATION SITE PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
ASTHENIA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CHEST PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
CYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG EFFECT DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG INEFFECTIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
DRUG INTOLERANCE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
FATIGUE
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
FEELING ABNORMAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
FEELING COLD
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
GRANULOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
HERNIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE INDURATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE IRRITATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE OEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE RASH
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE REACTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE SWELLING
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
INJECTION SITE WARMTH
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
LOCALISED OEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PAIN
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PARADOXICAL DRUG REACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PERIPHERAL SWELLING
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PUNCTURE SITE REACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
PYREXIA
|
0.34%
17/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
General disorders
XEROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLANGITIS SCLEROSING
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
FATTY LIVER ALCOHOLIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
GALLBLADDER DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC CYST
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC FIBROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATOCELLULAR INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
HEPATOSPLENOMEGALY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Immune system disorders
SERUM SICKNESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABDOMINAL WALL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ABSCESS LIMB
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ANAL ABSCESS
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ANAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ANGULAR CHEILITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BARTHOLIN'S ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BARTHOLINITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BODY TINEA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BORRELIA INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
BRONCHITIS
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CELLULITIS
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CHLAMYDIAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CHRONIC HEPATITIS C
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CRYPTOCOCCOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CRYPTOSPORIDIOSIS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CYSTITIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DERMO-HYPODERMITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
DIVERTICULITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EAR INFECTION
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ECZEMA INFECTED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ENTEROBIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ENTEROCOCCAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ERYSIPELAS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EYE INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
EYE INFECTION STAPHYLOCOCCAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FOLLICULITIS
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL CANDIDIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL HERPES
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GENITAL INFECTION FUNGAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GINGIVAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GROIN ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
GYNAECOLOGICAL CHLAMYDIA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES OPHTHALMIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HERPES ZOSTER
|
0.96%
48/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
HIV INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INCISION SITE ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFECTIOUS MONONUCLEOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFLUENZA
|
0.34%
17/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
INFUSION SITE INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LARYNGITIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
LUNG INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MASTOIDITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MOLLUSCUM CONTAGIOSUM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
MYCOBACTERIUM MARINUM INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
NAIL CANDIDA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
NASAL ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.90%
45/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OPHTHALMIC HERPES ZOSTER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL HERPES
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
ORAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OTITIS MEDIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
OVERGROWTH BACTERIAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PAPILLOMA VIRAL INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PARONYCHIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PAROTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERIODONTITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PHARYNGITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PILONIDAL CYST
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PURULENT DISCHARGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RASH PUSTULAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
RHINITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SALPINGITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SEPSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SIALOADENITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SINUSITIS
|
0.26%
13/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SKIN BACTERIAL INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SKIN CANDIDA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SKIN INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STOMA SITE ABSCESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
STOMA SITE CANDIDA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
SUPERINFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TINEA PEDIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TONSILLITIS
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TOOTH INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
TRICHOPHYTOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
UREAPLASMA INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.66%
33/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
UTERINE INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VAGINAL ABSCESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VARICELLA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VIRAL INFECTION
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Infections and infestations
WOUND INFECTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ACCIDENT AT HOME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC STENOSIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
STOMA SITE PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
SUBCUTANEOUS HAEMATOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WOUND SECRETION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
ALPHA 1 FOETOPROTEIN INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
BLOOD IRON DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
CRYSTAL URINE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
DOUBLE STRANDED DNA ANTIBODY POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
GIARDIA TEST POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
HUMAN PAPILLOMA VIRUS TEST POSITIVE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
RED BLOOD CELLS URINE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
SERUM FERRITIN DECREASED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
STOOL TRYPSIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
TUBERCULIN TEST POSITIVE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
VITAMIN B12 DECREASED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
WEIGHT DECREASED
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HAEMOCHROMATOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
LATENT AUTOIMMUNE DIABETES IN ADULTS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
POLYDIPSIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ANKYLOSING SPONDYLITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.76%
38/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ARTHROPATHY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FISTULA DISCHARGE
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
GOUTY ARTHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SPINAL DEFORMITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOARTHROPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
TEMPOROMANDIBULAR JOINT SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
TENDON DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.28%
14/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOMA IN SITU OF SKIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOLESTEATOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL NEOPLASM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA IN SITU
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE TUMOUR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PENILE WART
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
BENIGN INTRACRANIAL HYPERTENSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
BURNING SENSATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
CLUSTER HEADACHE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DEMYELINATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DIZZINESS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
DYSGEUSIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
EPILEPSY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
HEADACHE
|
0.44%
22/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
LETHARGY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
MIGRAINE
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
PARAESTHESIA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SCIATICA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SEIZURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
SPEECH DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
TEMPORAL LOBE EPILEPSY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
UTERINE CONTRACTIONS DURING PREGNANCY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
AGITATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
ANTICIPATORY ANXIETY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
ANXIETY
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
DEPRESSION
|
0.34%
17/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
INSOMNIA
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
PANIC REACTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Psychiatric disorders
STRESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
DYSURIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
IGA NEPHROPATHY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URETHRAL DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
BALANOPOSTHITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
MENOPAUSAL SYMPTOMS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
UTERINE DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VULVAL ULCERATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VULVAR EROSION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Reproductive system and breast disorders
VULVOVAGINAL ERYTHEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.24%
12/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA PAROXYSMAL NOCTURNAL
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL ULCER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISCOLOURED
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.12%
6/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA AREATA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
CHRONIC PIGMENTED PURPURA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS LUPUS ERYTHEMATOSUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.16%
8/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS PSORIASIFORM
|
0.36%
18/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.44%
22/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.10%
5/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
GRANULOMA SKIN
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
GUTTATE PSORIASIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HENOCH-SCHONLEIN PURPURA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
HYPERSENSITIVITY VASCULITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
LICHEN PLANUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
LICHEN SCLEROSUS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PALMOPLANTAR KERATODERMA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PRURIGO
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.22%
11/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
1.3%
66/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
PYODERMA GANGRENOSUM
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.42%
21/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.06%
3/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.14%
7/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN MASS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN PLAQUE
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.08%
4/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Surgical and medical procedures
TONSILLECTOMY
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HOT FLUSH
|
0.02%
1/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
HYPERTENSION
|
0.18%
9/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
|
Vascular disorders
VASCULITIS
|
0.04%
2/5025 • Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
|
Additional Information
Global Medical Information
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Restriction type: OTHER