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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous leukemia (AML).
The primary objective was to evaluate the preliminary efficacy of venetoclax administered orally in participants with relapsed and/or refractory (R/R) acute myelogenous leukemia (AML) or frontline therapy in patients with AML who were unfit for intensive therapy. The secondary objective was to evaluate the preliminary safety of venetoclax administered orally in patients with AML. The first portion of the study was to consist of 19 participants with the objective of evaluating anti-tumor effects and confirming the safety of the regimen. The second portion (expansion) was to consist of 35 additional subjects to evaluate anti-tumor effects and safety and was to commence if an adequate efficacy signal (i.e., ≥ 5/19 achieved complete remission [CR], CR with incomplete bone marrow recovery [CRi] or partial remission [PR]) had been observed in the first portion of the study. The criterion for success would have been met if ≥ 16 of 54 participants achieved remission. The efficacy signal from first portion of the study was deemed insufficient for enrollment into the second portion of the study, as 4 of the 19 subjects achieved CR/CRi. During the trial, a number of participants were in screening at the point of the interim analysis. Given the early signs of clinical activity of venetoclax, disease severity, and prognosis of these participants without available options for therapy, they were allowed to initiate treatment ahead of completion of the interim analysis. Therefore, 32 participants were enrolled. No additional participants were screened or treated after the interim analysis was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-199 | Experimental | Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-199 | Drug | Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Remission Rate | The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate | The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
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Inclusion Criteria:
Histological or cytological confirmation of relapsed or refractory acute myelogenous leukemia (AML) (by World Health Organization [WHO] classification) or untreated AML in participants who are unfit for intensive therapy.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Participant must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula using ideal body mass (IBM) instead of mass.
Participant must have adequate liver function as demonstrated by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jalaja Potluri, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27520294 | Result | Konopleva M, Pollyea DA, Potluri J, Chyla B, Hogdal L, Busman T, McKeegan E, Salem AH, Zhu M, Ricker JL, Blum W, DiNardo CD, Kadia T, Dunbar M, Kirby R, Falotico N, Leverson J, Humerickhouse R, Mabry M, Stone R, Kantarjian H, Letai A. Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia. Cancer Discov. 2016 Oct;6(10):1106-1117. doi: 10.1158/2159-8290.CD-16-0313. Epub 2016 Aug 12. |
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All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-199 | Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-199 | Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter. |
| 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 | Objective Remission Rate | The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline. | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
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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 | ABT-199 | Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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| Duration of Remission | Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Time to Progression | Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Progression-free Survival | Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Overall Survival | Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later. | Measured up to 2 years after the last subject had enrolled in the study. |
| Percentage of Participants Who Received Subsequent Stem Cell Transplant | The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Rate of Minimal Residual Disease (MRD) Negativity | The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Complete Remission With Incomplete Marrow Recovery (CRi) Rate | The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate | The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
| Adverse event not related to progression |
|
| Chose palliative care |
|
| Proceeded to transplant |
|
| Removed from study due to no response |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | ABT-199 | Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter. |
|
|
| Secondary | Complete Remission Rate | The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. | All participants who received at least 1 dose of study drug | Posted | Number | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Duration of Remission | Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan. | The duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan. | Posted | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
| Secondary | Time to Progression | Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment. | All participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment. | All participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later. | All participants who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | months | Measured up to 2 years after the last subject had enrolled in the study. |
|
|
|
| Secondary | Percentage of Participants Who Received Subsequent Stem Cell Transplant | The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized. | All participants who received at least 1 dose of study drug | Posted | Number | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Rate of Minimal Residual Disease (MRD) Negativity | The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate. | Participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Complete Remission With Incomplete Marrow Recovery (CRi) Rate | The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. | All participants who received at least 1 dose of study drug | Posted | Number | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| Secondary | Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate | The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier |
|
|
|
| 27 |
| 32 |
| 31 |
| 32 |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYDROCELE | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| INTRA-ABDOMINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| MESENTERITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| CELLULITIS OF MALE EXTERNAL GENITAL ORGAN | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| ENTEROCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| LEPTOTRICHIA INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PSEUDOMONAL BACTERAEMIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| SEPSIS | 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 |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| VIRAL PHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| VULVAL CELLULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| SCROTAL PAIN | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| CONJUNCTIVITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| PNEUMONIA | 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 |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | 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 |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| HAEMOGLOBINURIA | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| PURPURA | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D006425 |
| Hemic and Lymphatic Diseases |