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The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Induction Dose | Experimental | Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6. |
|
| Standard Induction Dose | Experimental | Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Adalimumab pre-filled syringe, administered by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Adalimumab Concentration at Week 8 | Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab | The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8 | Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Robinson | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27175116 | Result | Wu KC, Ran ZH, Gao X, Chen M, Zhong J, Sheng JQ, Kamm MA, Travis S, Wallace K, Mostafa NM, Shapiro M, Li Y, Thakkar RB, Robinson AM. Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease. Intest Res. 2016 Apr;14(2):152-63. doi: 10.5217/ir.2016.14.2.152. Epub 2016 Apr 27. |
| Label | URL |
|---|---|
| Related Info. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Induction Dose | Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6. |
| FG001 | Standard Induction Dose | Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Induction Dose | Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6. |
| BG001 | Standard Induction Dose |
| 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 | Mean Serum Adalimumab Concentration at Week 8 | Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method. | All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data. | Posted | Mean | Standard Deviation | μg/mL | Week 8 |
|
Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks).
A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.
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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 | Low Induction Dose (Double-blind) | Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo for adalimumab | Biological | Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind. |
|
| Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab | The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. | From Week 0 to Week 26 |
| Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab | Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively. | 26 weeks |
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below. | 35 weeks |
| Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
| Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
| CDAI: Mean Change From Baseline to Each Visit | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used. | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
| High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 | hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data. | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26 |
| Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 | Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data. | Baseline (Week 0) and Weeks 4 and 8 |
| Baseline (Week 0) to Week 8 |
Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6. |
|
|
| Secondary | Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab | The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter. | Safety Analysis Set: all participants who received at least 1 dose of study drug. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab | The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. | Safety Analysis Set. | Posted | Number | participants | From Week 0 to Week 26 |
|
|
|
| Secondary | Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab | Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively. | Safety Analysis Set. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below. | Safety Analysis Set. | Posted | Number | participants | 35 weeks |
|
|
|
| Secondary | Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
|
|
|
| Secondary | Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
|
|
|
| Secondary | CDAI: Mean Change From Baseline to Each Visit | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used. | ITT population. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26 |
|
|
|
| Secondary | High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 | hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data. | ITT population. | Posted | Median | Full Range | mg/L | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26 |
|
|
|
| Secondary | Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 | Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data. | ITT population. | Posted | Median | Full Range | μg/g | Baseline (Week 0) and Weeks 4 and 8 |
|
|
|
| Other Pre-specified | Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8 | Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL. | ITT population. | Posted | Baseline (Week 0) to Week 8 |
|
|
| 1 |
| 15 |
| 6 |
| 15 |
| EG001 | Standard Induction Dose (Double-blind) | Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6. | 1 | 15 | 7 | 15 |
| EG002 | Low Induction Dose (Open-label Extension) | Participants received open-label adalimumab 40 mg every other week for 18 weeks. | 1 | 13 | 6 | 13 |
| EG003 | Standard Induction Dose (Open-label Extension) | Participants received open-label adalimumab 40 mg every other week for 18 weeks. | 2 | 14 | 6 | 14 |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| TUBERCULOSIS GASTROINTESTINAL | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| ANAL ULCER | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| REGURGITATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| GASTROINTESTINAL INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| VULVOVAGINAL INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| ACID BASE BALANCE ABNORMAL | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| CLOSTRIDIUM TEST POSITIVE | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| PHARYNGEAL ULCERATION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.1 | 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.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Neutrophils <1.0x10^9/mcL (n=15,15) |
|
| Lymphocytes <0.5x10^3/mcL (n=15,13) |
|
| Albumin <20 g/L |
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| Calcium <1.75 mmol/L |
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| Uric Acid >500µmol/L |
|
| DBP ≤50 mm Hg or ≥15 mm Hg ↓ from BL |
|
| SBP ≥105 mm Hg or ≥15 mm Hg ↑ from BL |
|
| Pulse ≤50 bpm or ≥15 bpm ↓ from BL |
|
| Pulse SBP ≥120 bpm or ≥15 bpm ↑ from BL |
|
| Any TESAE |
|
| TEAE leading to discontinuation |
|
| Severe TEAE |
|
| TEAEs with reasonable possibility of being related |
|
| Deaths |
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