Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H9B-MC-BCDX | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Lack of efficacy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY 2127399 Q2W | Experimental | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. |
|
| LY2127399 Q4W | Experimental | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 | Drug | 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | Baseline through 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response | Week 48 | |
| Proportion of Participants With a Reduction in Steroid Dose | Baseline through 4 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Irving | Texas | 75061 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LY 2127399 Q2W | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| FG001 | LY2127399 Q4W | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY 2127399 Q2W | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| 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 | Percentage of Participants With Adverse Events (AEs) | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline through 4 years |
|
Not provided
All randomized participants who received at least 1 dose of study drug.
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 | LY 2127399 Q2W Treatment | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
Study terminated early due to lack of efficacy in parent studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575974 | tabalumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
|
| Change in SLE Disease Activity Index | Baseline, 4 years |
| Occurrence of New Severe SLE Flares | Baseline through 4 years |
| Proportion of Participants With Improvement in Lupus Quality of Life | 4 years |
| Change in Anti-double-stranded Deoxyribonucleic Acid Level | Baseline, 4 years |
| United States |
| BG001 | LY2127399 Q4W | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score | SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. | Mean | Standard Deviation | units on a scale |
|
| Anti-dsDNA Antibody Level (IU) | Mean | Standard Deviation | International Unit/Milliliter (IU/mL) |
|
| OG001 | LY2127399 Q4W | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
|
|
| Secondary | Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response | Zero participants analyzed. Data was not collected for analysis. | Posted | Week 48 |
|
|
| Secondary | Proportion of Participants With a Reduction in Steroid Dose | Zero participants analyzed. Data was not collected for analysis. | Posted | Baseline through 4 years |
|
|
| Secondary | Change in SLE Disease Activity Index | Zero participants analyzed. Data was not collected for analysis. | Posted | Baseline, 4 years |
|
|
| Secondary | Occurrence of New Severe SLE Flares | Zero participants analyzed. Data was not collected for analysis. | Posted | Baseline through 4 years |
|
|
| Secondary | Proportion of Participants With Improvement in Lupus Quality of Life | Zero participants analyzed. Data was not collected for analysis. | Posted | 4 years |
|
|
| Secondary | Change in Anti-double-stranded Deoxyribonucleic Acid Level | Zero participants analyzed. Data was not collected for analysis. | Posted | Baseline, 4 years |
|
|
| 129 |
| 937 |
| 464 |
| 937 |
| EG001 | LY2127399 Q4W Treatment | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | 64 | 578 | 232 | 578 |
| EG002 | LY 2127399 Q2W Follow Up | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up. | 57 | 810 | 37 | 810 |
| EG003 | LY2127399 Q4W Follow Up | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up. | 51 | 526 | 24 | 526 |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bundle branch block bilateral | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myocardial fibrosis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tricuspid valve disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mineralocorticoid deficiency | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Implant site erosion | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nodular regenerative hyperplasia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Blastocystis infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Cervicitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Infectious colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Meningitis cryptococcal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pyonephrosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sepsis syndrome | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Vulval cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Bone fissure | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Bronchial injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Electrocardiogram QRS complex shortened | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Cholesterosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ketosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Benign vaginal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Brenner tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| IIIrd nerve disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neuropsychiatric lupus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| VIth nerve disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Delirium tremens | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lupus nephritis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mucocutaneous ulceration | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Precancerous skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Poor venous access | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided