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| Name | Class |
|---|---|
| Veeda Clinical Research | INDUSTRY |
Not provided
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The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.
This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected Participants | HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups:
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care. | Baseline (Week 0) to Week 144 |
| Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care. | Baseline (Week 0) to Week 144 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Adverse Events (Weeks 0-144), Per Event | Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified'). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Bloch, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HIV-infected Participants | HIV-infected participants starting with Kaletra tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HIV-infected Participants | HIV-infected participants starting with Kaletra tablets. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | participants with age recorded at Baseline |
| 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 | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care. | Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. | Posted | Mean | Standard Deviation | cells/μL | Baseline (Week 0) to Week 144 |
|
|
Through Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
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 | HIV-infected Participants | HIV-infected participants starting with Kaletra tablets. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| Weeks 0 to 144 |
| Prevalence of Adverse Events (Weeks 0-144), Per Participant | Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified'). | Weeks 0 to 144 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care. | Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. | Posted | Mean | Standard Deviation | log copies/mL | Baseline (Week 0) to Week 144 |
|
|
|
| Other Pre-specified | Prevalence of Adverse Events (Weeks 0-144), Per Event | Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified'). | Posted | Number | percentage of adverse events | Weeks 0 to 144 | Adverse Events | Adverse Events |
|
|
|
| Other Pre-specified | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified'). | Posted | Number | percentage of participants | Weeks 0 to 144 |
|
|
|
| 79 |
| 3,039 |
| 0 |
| 0 |
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MACROCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PLASMACYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ATRIOVENTRICULAR DISSOCIATION | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CARDIAC VALVE DISEASE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DEGENERATIVE MITRAL VALVE DISEASE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| EXTRASYSTOLES | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PLEUROPERICARDITIS | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| EYE SWELLING | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ALCOHOLIC PANCREATITIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CHRONIC GASTRITIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| GINGIVITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LEUKOPLAKIA ORAL | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PANCREATIC CYST | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SALIVARY GLAND CYST | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CHILLS | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DRUG INTOLERANCE | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HEPATIC LESION | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| AIDS DEMENTIA COMPLEX | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ACQUIRED IMMUNODEFICIENCY SYNDROME | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| CHLAMYDIAL INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ENDOCARDITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| FUNGAL OESOPHAGITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| HELICOBACTER GASTRITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| LEISHMANIASIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| LYMPH NODE TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| LYMPHOGRANULOMA VENEREUM | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| MYCOBACTERIUM AVIUM COMPLEX INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| OPHTHALMIC HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SALMONELLOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SECONDARY TRANSMISSION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| CYTOMEGALOVIRUS TEST POSITIVE | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| INGUINAL MASS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ANAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPE STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| ANOGENITAL WARTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| BURKITT'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| KAPOSI'S SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| PLASMABLASTIC LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| ATAXIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| BALANCE DISORDER | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CEREBRAL ARTERIOSCLEROSIS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CEREBRAL ATROPHY | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| FACIAL PARESIS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MENINGEAL DISORDER | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RADICULOPATHY | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ABORTION | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| ABORTION MISSED | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| MATERNAL CONDITION AFFECTING FOETUS | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| PLACENTAL INSUFFICIENCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| PREMATURE BABY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| APATHY | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RENAL CYST | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| URINARY BLADDER POLYP | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ADENOMYOSIS | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MENOMETRORRHAGIA | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PROSTATIC MASS | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at Week 60 |
|
|
| Change at Week 72 |
|
|
| Change at Week 84 |
|
|
| Change at Week 96 |
|
|
| Change at Week 108 |
|
|
| Change at Week 120 |
|
|
| Change at Week 132 |
|
|
| Change at Week 144 |
|
|
| Title | Measurements |
|---|---|
|
| High LDL Cholesterol |
|
| Hyperglycemia |
|
| Hyperbilirubinemia |
|
| Elevated AST |
|
| Elevated ALT |
|
| Elevated γGT |
|
| Elevated Alkaline Phosphatase |
|
| Stomatitis |
|
| Nausea |
|
| Vomiting |
|
| Diarrhea |
|
| Abdominal Pain |
|
| Mood Disorder |
|
| Neurocerebellar Disorder |
|
| Neurocontrol Disorder |
|
| Headache |
|
| Fatigue |
|
| Fever |
|
| Not Specified |
|
| Title | Measurements |
|---|---|
|
| High LDL Cholesterol |
|
| Hyperglycemia |
|
| Hyperbilirubinemia |
|
| Elevated AST |
|
| Elevated ALT |
|
| Elevated γGT |
|
| Elevated Alkaline Phosphatase |
|
| Stomatitis |
|
| Nausea |
|
| Vomiting |
|
| Diarrhea |
|
| Abdominal Pain |
|
| Mood Disorder |
|
| Neurocerebellar Disorder |
|
| Neurocontrol Disorder |
|
| Headache |
|
| Fatigue |
|
| Fever |
|
| Not Specified |
|