Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H9B-JE-BCDK | Other Identifier | Eli Lilly and Company |
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This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 milligrams (mg) Tabalumab | Experimental | 30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug) |
|
| 60 mg Tabalumab | Experimental | 60 mg tabalumab Q4W for 20 weeks (6 doses of study drug) |
|
| 120 mg Tabalumab | Experimental | 120 mg tabalumab Q4W for 20 weeks (6 doses of study drug) |
|
| Placebo Q4W | Placebo Comparator | Q4W for 20 weeks |
|
| 120 mg once every 2 weeks (Q2W) Tabalumab | Experimental | Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug) |
|
| Placebo Q2W | Placebo Comparator | Q2W for 20 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 (Tabalumab) | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) [Clinically Significant Effects] | Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC) | The following parameters are reported for the first SC injection of tabalumab: AUC(0-tlast) defined as AUC from time 0 to time t, where t is the time at the end of the dosing interval; AUC(0-2W) defined as AUC from time 0 to Week 2; and AUC(0-tau) defined as AUC during 1 dosing interval at steady state. | Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST ) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | Japan |
This dose-escalation study had 4 cohorts. Each cohort included 6 LY2127399 (tabalumab) participants and 2 placebo participants. Participants treated once every 2 weeks (Q2W) or once every 4 weeks (Q4W) and had a follow-up visit at Week 32. Additional visits beyond Week 32 were scheduled, as needed, for B cell count monitoring (up to 12 weeks).
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 mg Tabalumab Q4W | Tabalumab: 30 milligrams (mg) subcutaneous (SC) injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| FG001 | 60 mg Tabalumab Q4W | Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| FG002 | 120 mg Tabalumab Q4W | Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| FG003 | 120 mg Tabalumab Q2W | Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
| FG004 | Placebo | Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized participants who received at least 1 dose of study drug (tabalumab or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg Tabalumab Q4W | Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| BG001 | 60 mg Tabalumab Q4W | Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| 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 (AEs) [Clinically Significant Effects] | Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo). | Posted | Count of Participants | Participants | No | Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring) |
|
Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
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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 | 30 mg Tabalumab Q4W | Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EYE MOVEMENT DISORDER | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
The anti-CCP data were difficult to interpret and compare for trends due to the 2 different methods of analysis used and the high variability in the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575974 | tabalumab |
Not provided
Not provided
Not provided
Not provided
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|
|
| Placebo | Drug | Administered subcutaneously |
|
| PK of Tabalumab: Maximum Observed Drug Concentration (Cmax) | Cmax for the first SC injection of tabalumab is reported. | Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose |
| Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts | B-lymphocyte antigen, CD20+, is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Percent change from baseline in B cell counts=[(post-baseline CD20+ B cell count-baseline CD20+ B cell count)/(baseline CD20+ B cell count)]*100. A negative change indicates a decrease in cell count. | Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32 |
| Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method] | During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No post-baseline samples from the 120 mg tabalumab Q4W and Q2W cohorts were analyzed using the Inova ELISA method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition. | Baseline, Week 24 |
| Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method) | During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No baseline samples from the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts were analyzed using the Roche Cobas 6000 method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition. | Baseline, Week 24 |
| Change From Baseline in Rheumatoid Factor (RF) | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis (RA). Higher RF levels indicate an aggressive RA and a higher risk of joint damage. A decrease in RF levels indicate an improvement in the participant's condition. | Baseline, Week 24 |
| Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA) | Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. A negative change indicates a decrease in immunoglobulin levels. | Baseline, Weeks 4, 16, 24, and 32 |
| Percent Change From Baseline in CRP | CRP is an indicator of inflammation. The percent change from baseline in CRP=[(post-baseline CRP- baseline CRP)/(baseline CRP)]*100. A negative change indicates an improvement in the participant's condition. | Baseline, Weeks 4, 8, 16, and 24 |
| Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Reference ranges are gender-specific and can vary slightly among laboratories. The normal range is approximately ≤10 millimeters per hour (mm/h) for males and ≤20 mm/h for females. Higher scores indicate greater inflammation. The percent change from baseline in ESR=[(post-baseline ESR- baseline ESR)/(baseline ESR)]*100. A decrease in ESR indicates an improvement in the participant's condition. | Baseline, Weeks 4, 8, 16, and 24 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukui | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gunma | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ibaraki | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miyagi | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | Japan |
| Death |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | 120 mg Tabalumab Q4W | Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| BG003 | 120 mg Tabalumab Q2W | Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
| BG004 | Placebo | Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Current Use of Corticosteroids | Count of Participants | Participants | No |
|
| Body Weight | Mean | Standard Deviation | kilograms (kg) |
|
| C-Reactive Protein (CRP) | CRP is an indicator of inflammation. Higher values indicate a greater amount of inflammation | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| OG002 | 120 mg Tabalumab Q4W | Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). |
| OG003 | 120 mg Tabalumab Q2W | Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
| OG004 | Placebo | Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). |
|
|
| Secondary | Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC) | The following parameters are reported for the first SC injection of tabalumab: AUC(0-tlast) defined as AUC from time 0 to time t, where t is the time at the end of the dosing interval; AUC(0-2W) defined as AUC from time 0 to Week 2; and AUC(0-tau) defined as AUC during 1 dosing interval at steady state. | Randomized participants who received at least 1 dose of tabalumab and had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliliter (mcg*day/mL) | Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose |
|
|
|
| Secondary | PK of Tabalumab: Maximum Observed Drug Concentration (Cmax) | Cmax for the first SC injection of tabalumab is reported. | Randomized participants who received at least 1 dose of tabalumab and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose |
|
|
|
| Secondary | Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts | B-lymphocyte antigen, CD20+, is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Percent change from baseline in B cell counts=[(post-baseline CD20+ B cell count-baseline CD20+ B cell count)/(baseline CD20+ B cell count)]*100. A negative change indicates a decrease in cell count. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline B cell assessment. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32 |
|
|
|
| Secondary | Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method] | During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No post-baseline samples from the 120 mg tabalumab Q4W and Q2W cohorts were analyzed using the Inova ELISA method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Inova ELISA method. No participants were analyzed in the 120 mg tabalumab Q4W and Q2W cohorts. | Posted | Mean | Standard Deviation | units (U) | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method) | During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No baseline samples from the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts were analyzed using the Roche Cobas 6000 method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Roche Cobas 6000 method. No participants were analyzed in the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts. | Posted | Median | Full Range | units per milliliter (U/mL) | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Rheumatoid Factor (RF) | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis (RA). Higher RF levels indicate an aggressive RA and a higher risk of joint damage. A decrease in RF levels indicate an improvement in the participant's condition. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline RF level assessment. | Posted | Mean | Standard Deviation | kilo units per liter (kU/L) | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA) | Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. A negative change indicates a decrease in immunoglobulin levels. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline serum immunoglobulin assessment. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline, Weeks 4, 16, 24, and 32 |
|
|
|
| Secondary | Percent Change From Baseline in CRP | CRP is an indicator of inflammation. The percent change from baseline in CRP=[(post-baseline CRP- baseline CRP)/(baseline CRP)]*100. A negative change indicates an improvement in the participant's condition. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline CRP assessment. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 4, 8, 16, and 24 |
|
|
|
| Secondary | Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Reference ranges are gender-specific and can vary slightly among laboratories. The normal range is approximately ≤10 millimeters per hour (mm/h) for males and ≤20 mm/h for females. Higher scores indicate greater inflammation. The percent change from baseline in ESR=[(post-baseline ESR- baseline ESR)/(baseline ESR)]*100. A decrease in ESR indicates an improvement in the participant's condition. | Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline ESR assessment. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 4, 8, 16, and 24 |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 60 mg Tabalumab Q4W | Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). | 1 | 6 | 4 | 6 |
| EG002 | 120 mg Tabalumab Q4W | Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). | 1 | 6 | 3 | 6 |
| EG003 | 120 mg Tabalumab Q2W | Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). | 1 | 6 | 6 | 6 |
| EG004 | Placebo | Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20). Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20). | 1 | 8 | 5 | 8 |
| OCULAR HYPERTENSION | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| STRABISMUS | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMONIA LEGIONELLA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| CONJUNCTIVAL ABRASION | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| GOITRE | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHALAZION | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PERIODONTITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| BLOOD URINE PRESENT | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| RHEUMATOID VASCULITIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| AUC(0-2W) |
|
|
| AUC(0-tau) |
|
|
|
| Week 1 |
|
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| Week 2 |
|
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| Week 3 |
|
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| Week 4 |
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| Week 6 |
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| Week 8 |
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| Week 12 |
|
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| Week 16 |
|
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| Week 20 |
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| Week 24 |
|
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| Week 32 |
|
|
|
| IgG, Week 16 |
|
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| IgG, Week 24 |
|
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| IgG, Week 32 |
|
|
| IgM, Week 4 |
|
|
| IgM, Week 16 |
|
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| IgM, Week 24 |
|
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| IgM, Week 32 |
|
|
| IgA, Week 4 |
|
|
| IgA, Week 16 |
|
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| IgA, Week 24 |
|
|
| IgA, Week 32 |
|
|
|
| Week 8 |
|
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| Week 16 |
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| Week 24 |
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| Week 8 |
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| Week 16 |
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| Week 24 |
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