A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Study Details
Study Description
Brief Summary
This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Following communication of the results of the primary progression-free survival (PFS) analysis from the Phase 3 BELLINI study (Study M14-031; NCT02755597), the company-sponsored MM studies were placed on partial clinical hold (PCH) in March 2019 by the United States (US) Food and Drug Administration and enrollment was halted. The sponsor did not pursue release of the PCH for this study; therefore, enrollment was not re-opened. In accordance with the terms of the PCH, participants who were deriving clinical benefit were allowed to continue to receive treatment. One participant was still active in Part 1 of the study when the sponsor decided not to pursue release of the PCH (in January 2020) and, therefore, continued to receive treatment and have regular assessments until disease progression. The study was discontinued when the last participant completed study treatment. No participants were enrolled in Part 2 of the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Dose Escalation Venetoclax (400 mg oral [PO], once daily [QD]) administered with pomalidomide (4 mg PO, QD) and dexamethasone (40 mg once weekly [qw]) in 28-day cycles until documented disease progression, documented unacceptable toxicity, withdrawal of consent, or the participant met other criteria for discontinuation per study protocol |
Drug: Venetoclax
Tablet; oral
Other Names:
Drug: Pomalidomide
Capsule; oral
Other Names:
Drug: Dexamethasone
Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
|
| Experimental: Part 2: Dose Expansion, t(11;14) positive Participants positive for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) |
Drug: Venetoclax
Tablet; oral
Other Names:
Drug: Pomalidomide
Capsule; oral
Other Names:
Drug: Dexamethasone
Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
|
| Experimental: Part 2: Dose Expansion, t(11;14) negative Participants negative for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) |
Drug: Venetoclax
Tablet; oral
Other Names:
Drug: Pomalidomide
Capsule; oral
Other Names:
Drug: Dexamethasone
Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- Overall Response Rate (ORR) [Approximately 15 months]
ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
Secondary Outcome Measures
- Progression-Free Survival (PFS) [Approximately 20 months]
PFS is defined as the number of days from the date of first dose of any study drug to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.
- Duration of Response (DOR) [Approximately 15 months]
DOR for a given participant is defined as the number of days from the date of that participant's first documented response (Partial Response [PR] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.
- Time-to-progression (TTP) [Approximately 15 months]
TTP for a given participant is defined as the number of days from the date of first dose to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen
-
Measurable disease as described in the protocol
-
Received at least 1 prior line of therapy as described in the protocol
-
Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:
-
Received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
-
Refractory to lenalidomide
-
Exposed to a proteasome inhibitor (PI) alone or in combination with another agent
-
Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria
-
Has t(11;14) status as described in the protocol and meets the following criteria:
-
For Part 1: MM participants independent of cytogenetic profile
-
For Part 2, Arm A: participant must be t(11;14) positive
-
For Part 2, Arm B: participant must be t(11;14) negative
-
An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
-
Adequate kidney, liver and hematologic laboratory values
Exclusion Criteria:
-
Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
-
Known sensitivity to any IMiDs
-
Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
-
Autologous stem cell transplant within 12 weeks before the first dose of study drug
-
Known meningeal involvement of MM
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John B. Amos Cancer Center - C /ID# 202055 | Columbus | Georgia | United States | 31904 |
| 2 | University of Kansas Cancer Center /ID# 201292 | Fairway | Kansas | United States | 66205-2528 |
| 3 | Washington University-School of Medicine /ID# 201287 | Saint Louis | Missouri | United States | 63110 |
| 4 | Duke University Hospital /ID# 200805 | Durham | North Carolina | United States | 27710 |
| 5 | Ohio State Cancer Center /ID# 202443 | Columbus | Ohio | United States | 43210 |
| 6 | Hospital Universitario Germans Trias i Pujol /ID# 200959 | Badalona | Barcelona | Spain | 08916 |
| 7 | Hospital Universitario Vall d'Hebron /ID# 200967 | Barcelona | Spain | 08035 | |
| 8 | Hospital Clinico Universitario de Salamanca /ID# 200958 | Salamanca | Spain | 37007 | |
| 9 | Leicester Royal Infirmary /ID# 202238 | Leicester | England | United Kingdom | LE1 5WW |
| 10 | Norfolk and Norwich Univ Hosp /ID# 202240 | Norwich | Norfolk | United Kingdom | NR4 7UY |
| 11 | Univ Hospitals Birmingham NHS Foundation trust /ID# 203188 | Birmingham | United Kingdom | B15 2TG |
Sponsors and Collaborators
- AbbVie
- Celgene
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- M16-085
- 2017-004232-11
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Full Analysis Set: participants who received at least 1 dose of study drug |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Period Title: Overall Study | |
| STARTED | 8 |
| COMPLETED | 0 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | Total |
|---|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Total of all reporting groups |
| Overall Participants | 3 | 5 | 8 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
68.0
|
66.0
|
67.5
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
33.3%
|
4
80%
|
5
62.5%
|
| Male |
2
66.7%
|
1
20%
|
3
37.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
3
100%
|
4
80%
|
7
87.5%
|
| Black/African American |
0
0%
|
1
20%
|
1
12.5%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. |
| Time Frame | From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation |
|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Measure Participants | 3 | 5 |
| Any TEAE |
3
100%
|
5
100%
|
| TESAE |
3
100%
|
2
40%
|
| Title | Overall Response Rate (ORR) |
|---|---|
| Description | ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours. |
| Time Frame | Approximately 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Measure Participants | 3 | 5 | 8 |
| Number (95% Confidence Interval) [percentage of participants] |
66.7
2223.3%
|
60.0
1200%
|
62.5
781.3%
|
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | PFS is defined as the number of days from the date of first dose of any study drug to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug. |
| Time Frame | Approximately 20 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Measure Participants | 3 | 5 | 8 |
| Median (95% Confidence Interval) [days] |
220.0
|
NA
|
320.0
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | DOR for a given participant is defined as the number of days from the date of that participant's first documented response (Partial Response [PR] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored. |
| Time Frame | Approximately 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) and had disease progression or death due to multiple myeloma |
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Measure Participants | 2 | 3 | 5 |
| Median (95% Confidence Interval) [days] |
393.0
|
NA
|
393.0
|
| Title | Time-to-progression (TTP) |
|---|---|
| Description | TTP for a given participant is defined as the number of days from the date of first dose to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored. |
| Time Frame | Approximately 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) and had disease progression or death due to multiple myeloma |
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) |
| Measure Participants | 3 | 5 | 8 |
| Median (95% Confidence Interval) [days] |
420.0
|
NA
|
420.0
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 70 weeks. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant. | |||
| Arm/Group Title | Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | ||
| Arm/Group Description | Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) | ||
All Cause Mortality |
||||
| Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | 0/5 (0%) | ||
Serious Adverse Events |
||||
| Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 2/5 (40%) | ||
| Cardiac disorders | ||||
| ATRIAL FIBRILLATION | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| CARDIO-RESPIRATORY ARREST | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Infections and infestations | ||||
| PNEUMOCOCCAL INFECTION | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| PNEUMONIA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| PNEUMONIA STREPTOCOCCAL | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Investigations | ||||
| BLOOD LACTATE DEHYDROGENASE INCREASED | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| PANCREATIC NEOPLASM | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Nervous system disorders | ||||
| CEREBRAL INFARCTION | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| CEREBROVASCULAR ACCIDENT | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| RESPIRATORY FAILURE | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Participants Positive for t(11;14) Translocation | Participants Negative for t(11;14) Translocation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 5/5 (100%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 1/3 (33.3%) | 1 | 3/5 (60%) | 4 |
| LEUKOPENIA | 1/3 (33.3%) | 3 | 2/5 (40%) | 14 |
| LYMPHOPENIA | 0/3 (0%) | 0 | 2/5 (40%) | 6 |
| NEUTROPENIA | 2/3 (66.7%) | 10 | 4/5 (80%) | 34 |
| THROMBOCYTOPENIA | 1/3 (33.3%) | 1 | 2/5 (40%) | 6 |
| Cardiac disorders | ||||
| CARDIAC FAILURE | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Ear and labyrinth disorders | ||||
| EAR DISCOMFORT | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Gastrointestinal disorders | ||||
| CONSTIPATION | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| DIARRHOEA | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| FLATULENCE | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| NAUSEA | 1/3 (33.3%) | 1 | 1/5 (20%) | 2 |
| TOOTHACHE | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| VOMITING | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| General disorders | ||||
| CHILLS | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| FATIGUE | 2/3 (66.7%) | 3 | 2/5 (40%) | 3 |
| NON-CARDIAC CHEST PAIN | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| PYREXIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| Hepatobiliary disorders | ||||
| HYPERBILIRUBINAEMIA | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| Infections and infestations | ||||
| BRONCHITIS | 0/3 (0%) | 0 | 1/5 (20%) | 3 |
| HERPES ZOSTER | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| NASOPHARYNGITIS | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| VULVOVAGINAL MYCOTIC INFECTION | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Investigations | ||||
| ALANINE AMINOTRANSFERASE INCREASED | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 1/3 (33.3%) | 2 | 1/5 (20%) | 1 |
| BLOOD CREATININE INCREASED | 0/3 (0%) | 0 | 2/5 (40%) | 2 |
| BLOOD IMMUNOGLOBULIN G DECREASED | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| BLOOD LACTATE DEHYDROGENASE INCREASED | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| LYMPHOCYTE COUNT DECREASED | 0/3 (0%) | 0 | 2/5 (40%) | 5 |
| NEUTROPHIL COUNT DECREASED | 1/3 (33.3%) | 1 | 1/5 (20%) | 5 |
| PLATELET COUNT DECREASED | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| WEIGHT DECREASED | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| WHITE BLOOD CELL COUNT DECREASED | 0/3 (0%) | 0 | 2/5 (40%) | 15 |
| Metabolism and nutrition disorders | ||||
| DECREASED APPETITE | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| HYPERGLYCAEMIA | 0/3 (0%) | 0 | 3/5 (60%) | 3 |
| HYPERKALAEMIA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| HYPERURICAEMIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| HYPOALBUMINAEMIA | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| HYPOCALCAEMIA | 0/3 (0%) | 0 | 2/5 (40%) | 2 |
| HYPOGLYCAEMIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| HYPOKALAEMIA | 1/3 (33.3%) | 1 | 3/5 (60%) | 5 |
| HYPOMAGNESAEMIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| HYPONATRAEMIA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| HYPOPHOSPHATAEMIA | 1/3 (33.3%) | 1 | 2/5 (40%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| BACK PAIN | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| BONE PAIN | 0/3 (0%) | 0 | 1/5 (20%) | 2 |
| FLANK PAIN | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| MUSCULOSKELETAL STIFFNESS | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| MYALGIA | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| NECK PAIN | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| PAIN IN EXTREMITY | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Nervous system disorders | ||||
| APHASIA | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| DISTURBANCE IN ATTENTION | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| DIZZINESS | 0/3 (0%) | 0 | 2/5 (40%) | 2 |
| DYSGEUSIA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| PARAESTHESIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 2 |
| TREMOR | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Psychiatric disorders | ||||
| ANXIETY | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| INSOMNIA | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| Reproductive system and breast disorders | ||||
| VULVOVAGINAL PRURITUS | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| COUGH | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| DYSPHONIA | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| DYSPNOEA | 2/3 (66.7%) | 3 | 1/5 (20%) | 1 |
| DYSPNOEA EXERTIONAL | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| NASAL CONGESTION | 1/3 (33.3%) | 1 | 1/5 (20%) | 1 |
| OROPHARYNGEAL PAIN | 2/3 (66.7%) | 2 | 0/5 (0%) | 0 |
| RESPIRATORY ACIDOSIS | 1/3 (33.3%) | 1 | 0/5 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| ERYTHEMA | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| RASH | 0/3 (0%) | 0 | 1/5 (20%) | 1 |
| Vascular disorders | ||||
| HYPERTENSION | 1/3 (33.3%) | 2 | 1/5 (20%) | 2 |
| HYPOTENSION | 1/3 (33.3%) | 1 | 1/5 (20%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
- M16-085
- 2017-004232-11