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This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humira | Participants who were prescribed Humira per approved prescribing information of Humira in Japan. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details. | From first dose of Humira up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Crohn's Disease Activity Index (CDAI) Score Over Time | The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
Not provided
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| Label | URL |
|---|---|
| Related Info | View source |
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Of the 511 patients enrolled, case report forms were not collected from 7 patients (N = 504). The safety analysis set excluded 115 enrolled patients due to "safety assessment impossible" (N = 389). The efficacy analysis set excluded 79 patients that were included in the safety analysis set due to "efficacy assessment impossible" (N = 310).
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| ID | Title | Description |
|---|---|---|
| FG000 | Humira | Participants who were prescribed Humira per approved prescribing information of Humira in Japan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Humira | Participants who were prescribed Humira per approved prescribing information of Humira in Japan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Events | An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details. | Safety Analysis Set | Posted | Number | participants | From first dose of Humira up to 3 years |
|
|
Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Humira | Participants who were prescribed Humira per approved prescribing information of Humira in Japan. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Feb 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2018 | Feb 15, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
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Not provided
| From first dose of Humira up to 3 years |
| Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years |
| Change in WPAI: CD Presenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years |
| Change in WPAI: CD Overall Work Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years |
| Change in WPAI: CD Activity Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | From first dose of Humira up to 3 years |
| Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine) | Endoscopic remission per endoscopy sub score. | From first dose of Humira up to 3 years |
| Change in C-Reactive Protein (CRP) Levels Over Time | CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation. | From first dose of Humira up to 3 years |
| Other |
|
| No Hospital Visit |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Crohn's Disease Activity Index (CDAI) Score Over Time | The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | units on a scale | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | percentage of work time missed | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Change in WPAI: CD Presenteeism Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | Percent impairment while working | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Change in WPAI: CD Overall Work Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | Percent overall work impairment | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Change in WPAI: CD Activity Impairment Over Time | WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | Percent activity impairment | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine) | Endoscopic remission per endoscopy sub score. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Count of Participants | Participants | From first dose of Humira up to 3 years |
|
|
|
| Secondary | Change in C-Reactive Protein (CRP) Levels Over Time | CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation. | Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment | Posted | Mean | Standard Deviation | mg/dL | From first dose of Humira up to 3 years |
|
|
|
| 3 |
| 389 |
| 58 |
| 389 |
| 104 |
| 389 |
| Fungal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Retroperitoneal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory tract infection fungal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fistula of small intestine | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Haemorrhoid operation | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Retroperitoneal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tracheobronchitis mycoplasmal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory tract infection fungal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thyroiditis subacute | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aortitis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal fistula | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fistula of small intestine | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Chest X-ray abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood beta-D-glucan increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Pancreatic enzymes increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Antinuclear antibody increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Double stranded DNA antibody positive | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Haemorrhoid operation | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
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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.
| D007410 | Intestinal Diseases |
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| Large intestine: Year 1 of administration |
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| Large intsetine: Year 2 of administration |
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| Large intestine: Year 3 of administration |
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| Small intestine: at first administration |
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| Small intestine: Month 6 of administration |
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| Small intestine: Year 1 of administration |
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| Small intestine: Year 2 of administration |
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| Small intestine: Year 3 of administration |
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| Both intestine: start of administration |
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| Both intestine: Mont 6 of administration |
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| Both intestine: Year 1 of administration |
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| Both intestine: Year 2 of administration |
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| Both intestine: Year 3 of administration |
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