Trial Outcomes & Findings for Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis (NCT NCT01076959)
NCT ID: NCT01076959
Last Updated: 2012-08-28
Results Overview
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Recruitment status
COMPLETED
Target enrollment
7972 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2012-08-28
Participant Flow
The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).
The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).
Participant milestones
| Measure |
Humira
Patients who received Humira for 24 weeks during the PMDA review period.
|
|---|---|
|
Overall Study
STARTED
|
7740
|
|
Overall Study
COMPLETED
|
5490
|
|
Overall Study
NOT COMPLETED
|
2250
|
Reasons for withdrawal
| Measure |
Humira
Patients who received Humira for 24 weeks during the PMDA review period.
|
|---|---|
|
Overall Study
Adverse Event
|
767
|
|
Overall Study
Lack of Efficacy
|
849
|
|
Overall Study
Non-compliance
|
274
|
|
Overall Study
Lost to Follow-up
|
241
|
|
Overall Study
Other
|
119
|
Baseline Characteristics
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Humira
n=7740 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
|---|---|
|
Age Continuous
|
60.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Age, Customized
<20 years
|
26 participants
n=5 Participants
|
|
Age, Customized
>=20-<30
|
165 participants
n=5 Participants
|
|
Age, Customized
>=30-<40
|
461 participants
n=5 Participants
|
|
Age, Customized
>=40-<50
|
828 participants
n=5 Participants
|
|
Age, Customized
>=50-<60
|
1803 participants
n=5 Participants
|
|
Age, Customized
>=60-<70
|
2515 participants
n=5 Participants
|
|
Age, Customized
>=70-<80
|
1676 participants
n=5 Participants
|
|
Age, Customized
>=80-<90
|
261 participants
n=5 Participants
|
|
Age, Customized
>=90
|
4 participants
n=5 Participants
|
|
Age, Customized
No data
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6388 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1352 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
7740 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Outcome measures
| Measure |
Humira
n=7740 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
Humira - Moderate Response
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Humira - No Response
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Effective Rate-Sum of Patients With Good or Moderate Response
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
|---|---|---|---|---|
|
Total Number of Patients With Adverse Events
|
27.8 Percentage of Patients
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Outcome measures
| Measure |
Humira
n=3341 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
Humira - Moderate Response
n=3341 Participants
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Humira - No Response
n=3341 Participants
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Effective Rate-Sum of Patients With Good or Moderate Response
n=3341 Participants
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
|---|---|---|---|---|
|
Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
|
20.4 Percentage of patients
|
45.7 Percentage of patients
|
33.9 Percentage of patients
|
66.1 Percentage of patients
|
PRIMARY outcome
Timeframe: Week 12Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Outcome measures
| Measure |
Humira
n=3927 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
Humira - Moderate Response
n=3927 Participants
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Humira - No Response
n=3927 Participants
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Effective Rate-Sum of Patients With Good or Moderate Response
n=3927 Participants
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
|---|---|---|---|---|
|
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
|
26.4 percentage of patients
|
42.6 percentage of patients
|
31.1 percentage of patients
|
68.9 percentage of patients
|
PRIMARY outcome
Timeframe: Week 24Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Outcome measures
| Measure |
Humira
n=4410 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
Humira - Moderate Response
n=4410 Participants
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Humira - No Response
n=4410 Participants
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Effective Rate-Sum of Patients With Good or Moderate Response
n=4410 Participants
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
|---|---|---|---|---|
|
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
|
30.7 Percentage of Patients
|
39.3 Percentage of Patients
|
29.9 Percentage of Patients
|
70.1 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 24Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.
Outcome measures
| Measure |
Humira
n=6802 Participants
Patients who received Humira for 24 weeks during the PMDA review period.
|
Humira - Moderate Response
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Humira - No Response
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
Effective Rate-Sum of Patients With Good or Moderate Response
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
|
|---|---|---|---|---|
|
Physicians' Overall Effectiveness Response Rating
Markedly Improved
|
29.1 Percentage of Patients
|
—
|
—
|
—
|
|
Physicians' Overall Effectiveness Response Rating
Improved
|
45.2 Percentage of Patients
|
—
|
—
|
—
|
|
Physicians' Overall Effectiveness Response Rating
Not Changed
|
19.6 Percentage of Patients
|
—
|
—
|
—
|
|
Physicians' Overall Effectiveness Response Rating
Not Assessable
|
6.1 Percentage of Patients
|
—
|
—
|
—
|
Adverse Events
Humira
Serious events: 469 serious events
Other events: 863 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Humira
n=7740 participants at risk
Patients who received Humira for 24 weeks during the PMDA review period.
|
|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Anemia folate deficiency
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Angina pectoris
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Atrial tachycardia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Right ventricular failure
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Eye disorders
Retinal vein occlusion
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Eye disorders
Scleritis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Eye disorders
Uveitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Eye disorders
Visual impairment
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Colitis ischemic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastritis hemorrhagic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Ileitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Melena
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Peritonitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Chest pain
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Death
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Device breakage
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Drowning
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Gait disturbance
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Hyperthermia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Local swelling
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Malaise
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Multiorgan failure
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Edema
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Edema peripheral
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Pyrexia
|
0.17%
13/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Jaundice
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Liver disorder
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Immune system disorders
Anaphylactoid reaction
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Bronchiolitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Bronchitis
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Bronchopneumonia
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Cellulitis
|
0.16%
12/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Cystitis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Endophthalmitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Erysipelas
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Hepatitis B
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Herpes zoster
|
0.16%
12/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Influenza
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Meningitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Meningitis aseptic
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Peritonsillar abscess
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia
|
0.53%
41/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia chlamydial
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia legionella
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Postoperative wound infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pulpitis dental
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pyelonephritis
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pyelonephritis acute
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pyothorax
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Rash pustular
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Sepsis
|
0.17%
13/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Septic shock
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Tooth abscess
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Tuberculosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Muscle abscess
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Abscess limb
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
7/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Psoas abscess
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Wound abscess
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.17%
13/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Bursitis infective
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Lung infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Tuberculosis gastrointestinal
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Enterocolitis viral
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Purulence
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Mycobacterial infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.34%
26/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Device related infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Post procedural infection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
10/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.08%
6/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.08%
6/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Blood glucose decreased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Blood glucose increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Blood pressure increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
C-reactive protein increased
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Platelet count decreased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
White blood cell count decreased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Blood beta-D-glucan abnormal
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Hepatic enzyme increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Cell marker increased
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Investigations
Candida test positive
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Atlantoaxial instability
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage IV
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer stage IV
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Amnesia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebellar infarction
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Demyelination
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Nervous system disorder
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Optic neuritis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Sciatica
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Syncope
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Putamen hemorrhage
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Renal failure acute
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Renal and urinary disorders
Henoch-Schonlein purpura nephritis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.52%
40/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
3/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse panbronchiolitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.06%
5/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
4/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash erythematosus
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Generalized erythema
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Aortic aneurysm
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Aortic dissection
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Hypotension
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Shock
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Vasculitis
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Vasculitis necrotizing
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.03%
2/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Vascular disorders
Arterial hemorrhage
|
0.01%
1/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
Other adverse events
| Measure |
Humira
n=7740 participants at risk
Patients who received Humira for 24 weeks during the PMDA review period.
|
|---|---|
|
General disorders
Injection site erythema
|
2.1%
160/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Injection site reaction
|
1.4%
108/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
General disorders
Pyrexia
|
1.3%
99/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
110/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
94/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.0%
79/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
78/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
255/7740 • Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER