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This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants who received Humira® | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. | Up to Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Gastrointestinal Symptoms | Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications according to the Package Insert include patients who had any of the following:
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All participants who received Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Mikami, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32814420 | Derived | Suzuki Y, Hagiwara T, Kobayashi M, Morita K, Shimamoto T, Hibi T. Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behcet's disease: results from a large real-world observational study. Intest Res. 2021 Jul;19(3):301-312. doi: 10.5217/ir.2020.00013. Epub 2020 Aug 20. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 473 participants were enrolled in the study; 462 participants were analyzed for safety and 383 participants were analyzed for efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Who Received Humira® | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Who Received Humira® | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data was unavailable for one participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. | Safety analysis set: All participants who received at least one administration of Humira® during the study (after informed consent or first administration of Humira®) and for 70 days following the last scheduled administration of Humira®. | Posted | Count of Participants | Participants | Up to Week 156 |
|
Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Who Received Humira® | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRONCHITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGULAR CHEILITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2013 | Dec 3, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Dec 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| Up to Week 156 |
| Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. | Up to Week 156 |
| Number of Participants With Cardinal Symptoms of Behcet's Disease | The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | Up to Week 156 |
| Number of Participants With Accessory Symptoms of Behcet's Disease | The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | Up to Week 156 |
| Number of Participants With Degree of Improvement of Endoscopic Findings | The number of participants with improvement in endoscopic findings is assessed. | Up to Week 156 |
| Changes in C-reactive Protein (CRP) | The change in CRP from baseline through the end of the study was assessed. | Up to Week 156 |
| Unevaluable for safety |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Demographic data was unavailable for one participant. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Global Assessment of Gastrointestinal Symptoms | Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Count of Participants | Participants | Up to Week 156 |
|
|
|
| Secondary | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Count of Participants | Participants | Up to Week 156 |
|
|
|
| Secondary | Number of Participants With Cardinal Symptoms of Behcet's Disease | The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Count of Participants | Participants | Up to Week 156 |
|
|
|
| Secondary | Number of Participants With Accessory Symptoms of Behcet's Disease | The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Count of Participants | Participants | Up to Week 156 |
|
|
|
| Secondary | Number of Participants With Degree of Improvement of Endoscopic Findings | The number of participants with improvement in endoscopic findings is assessed. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Count of Participants | Participants | Up to Week 156 |
|
|
|
| Secondary | Changes in C-reactive Protein (CRP) | The change in CRP from baseline through the end of the study was assessed. | All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. | Posted | Mean | Standard Deviation | mg/dL | Up to Week 156 |
|
|
|
| 4 |
| 462 |
| 75 |
| 462 |
| 165 |
| 462 |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| MENINGITIS LISTERIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PERIODONTITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PSEUDOMEMBRANOUS COLITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| COLONIC ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHRONIC MYELOMONOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| MYELODYSPLASTIC SYNDROME TRANSFORMATION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANAEMIA MEGALOBLASTIC | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ADRENAL DISORDER | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DIABETES INSIPIDUS | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| THYROIDITIS SUBACUTE | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BEHCET'S SYNDROME | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEAL ULCER | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FISTULA OF SMALL INTESTINE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DENTAL CYST | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABORTION MISSED | Pregnancy, puerperium and perinatal conditions | MedDRA version 19.1 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| MENINGITIS LISTERIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| OTITIS MEDIA CHRONIC | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PERIODONTITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PSEUDOMEMBRANOUS COLITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| VULVOVAGINAL CANDIDIASIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ENTERITIS INFECTIOUS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ENTEROCOLITIS VIRAL | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| COLONIC ABSCESS | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHRONIC MYELOMONOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| MYELODYSPLASTIC SYNDROME TRANSFORMATION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANAEMIA MEGALOBLASTIC | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ADRENAL DISORDER | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DIABETES INSIPIDUS | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| THYROIDITIS SUBACUTE | Endocrine disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPERAMYLASAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPERLIPASAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| OBSESSIVE-COMPULSIVE DISORDER | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DEPRESSIVE SYMPTOM | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DYSLALIA | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| VITREOUS FLOATERS | Eye disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BEHCET'S SYNDROME | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PHARYNGEAL ULCERATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTRITIS ALCOHOLIC | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEAL ULCER | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INTESTINAL ULCER | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FISTULA OF SMALL INTESTINE | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FAECES SOFT | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DENTAL CYST | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ALCOHOLIC LIVER DISEASE | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ABORTION MISSED | Pregnancy, puerperium and perinatal conditions | MedDRA version 19.1 | Non-systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| MALAISE | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| ANTITHROMBIN III DECREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| BLOOD BETA-D-GLUCAN INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| BRAIN NATRIURETIC PEPTIDE INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| COMPUTERISED TOMOGRAM THORAX ABNORMAL | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| LIVER FUNCTION TEST INCREASED | Investigations | MedDRA version 19.1 | Non-systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DYSHIDROTIC ECZEMA | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| HAEMORRHAGE SUBCUTANEOUS | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| GENERALISED ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| Global assessment score = 2 |
|
| Global assessment score = 3 |
|
| Global assessment score = 4 |
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 52 |
|
|
| Week 76 |
|
|
| Week 104 |
|
|
| Week 128 |
|
|
| Week 156 |
|
|
| Global assessment score = 2 |
|
| Global assessment score = 3 |
|
| Global assessment score = 4 |
|
| Abdominal pain at week 4 |
|
|
| Abdominal pain at week 8 |
|
|
| Abdominal pain at week 12 |
|
|
| Abdominal pain at week 24 |
|
|
| Abdominal pain at week 52 |
|
|
| Abdominal pain at week 76 |
|
|
| Abdominal pain at week 104 |
|
|
| Abdominal pain at week 128 |
|
|
| Abdominal pain at week 156 |
|
|
| Diarrhoea at week 0 (baseline) |
|
|
| Diarrhoea at week 4 |
|
|
| Diarrhoea at week 8 |
|
|
| Diarrhoea at week 12 |
|
|
| Diarrhoea at week 24 |
|
|
| Diarrhoea at week 52 |
|
|
| Diarrhoea at week 76 |
|
|
| Diarrhoea at week 104 |
|
|
| Diarrhoea at week 128 |
|
|
| Diarrhoea at week 156 |
|
|
| Other gastrointestinal symptoms at week 0/baseline |
|
|
| Other gastrointestinal symptoms at week 4 |
|
|
| Other gastrointestinal symptoms at week 8 |
|
|
| Other gastrointestinal symptoms at week 12 |
|
|
| Other gastrointestinal symptoms at week 24 |
|
|
| Other gastrointestinal symptoms at week 52 |
|
|
| Other gastrointestinal symptoms at week 76 |
|
|
| Other gastrointestinal symptoms at week 104 |
|
|
| Other gastrointestinal symptoms at week 128 |
|
|
| Other gastrointestinal symptoms at week 156 |
|
|
| Assessment presence and baseline absence |
|
| Assessment presence and baseline presence |
|
| Recurrent aphthous ulcer of oral mucosa at week104 |
|
|
| Recurrent aphthous ulcer of oral mucosa at week156 |
|
|
| Cutaneous symptoms at week 52 |
|
|
| Cutaneous symptoms at week 104 |
|
|
| Cutaneous symptoms at week 156 |
|
|
| Eye symptoms at week 52 |
|
|
| Eye symptoms at week 104 |
|
|
| Eye symptoms at week 156 |
|
|
| Ulceration of vulva at week 52 |
|
|
| Ulceration of vulva at week 104 |
|
|
| Ulceration of vulva at week 156 |
|
|
| Assessment presence and baseline absence |
|
| Assessment presence and baseline presence |
|
| Arthritis without deformity/ stiffness at week 104 |
|
|
| Arthritis without deformity/ stiffness at week 156 |
|
|
| Epididymitis at week 52 |
|
|
| Epididymitis at week 104 |
|
|
| Epididymitis at week 156 |
|
|
| Vascular lesions at week 52 |
|
|
| Vascular lesions at week 104 |
|
|
| Vascular lesions at week 156 |
|
|
| Moderate to severe CNS lesions at week 52 |
|
|
| Moderate to severe CNS lesions at week 104 |
|
|
| Moderate to severe CNS lesions at week 156 |
|
|
| Unchanged |
|
| Aggravated |
|
| Unassessable |
|
| Week 24 to < Week 52 |
|
|
| Week 52 to < Week 76 |
|
|
| Week 76 to < Week 104 |
|
|
| Week 104 to < Week 128 |
|
|
| Week 128 to < Week 160 |
|
|
|
| Week 52 |
|
|
| Week 76 |
|
|
| Week 104 |
|
|
| Week 128 |
|
|
| Week 156 |
|
|