Multiple Myeloma
Conditions
Keywords
Relapsed Refractory multiple myeloma, Antibody-drug conjugate, Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events, Quality of Life Questionnaire 20-item Multiple Myeloma module, Multiple Myeloma, Quality of Life Questionnaire 30-item Core module
Brief summary
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.
Interventions
DRUGBelantamab mafodotin frozen liquid
Belantamab mafodotin will be available as frozen liquid. Frozen liquid will be available as 30 milligram (mg)/vial solution in a single use vial with unit dose strength of 2.5 or 3.4 mg/kg. Belantamab mafodotin will be administered as IV solution over at least 30 minutes. Frozen belantamab mafodotin will be diluted in 0.9 percent saline and administered via infusion pump.
DRUGBelantamab mafodotin lyophilized powder
Belantamab mafodotin will be available as lyophilized powder. Lyophilized powder will be available as 100 mg/vial in single-use vial for reconstitution with unit dose strength of 3.4 mg/kg. Lyophilized belantamab mafodotin will be reconstituted using water for injection and diluted with saline before use.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who provided signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 18 years or older. * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Participants with histologically or cytologically confirmed diagnosis of MM as defined in IMWG, 2014 criteria, and participant has undergone stem cell transplant or is considered transplant ineligible and has failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody (example \[e.g.\], daratumumab) alone or in combination, and is refractory to an Immunomodulatory drug (IMiD) (that is \[i.e.\], lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). * The participant has measurable disease with at least one of the following: Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per Liter \[g/L\]); Urine M-protein \>=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay: Involved FLC level \>=10 mg/dL (\>=100 mg/Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was \>100 days prior to study enrollment; no active infection(s); participants meet the remainder of the eligibility criteria outlined in the protocol. * Participants with adequate organ system functions as defined follows: Absolute neutrophil count (ANC) \>=1.0 X 10\^9/L; Hemoglobin \>=8.0 g/dL; Platelets\>= 50 X 10\^9/L; Total bilirubin \<=1.5X Upper limit of normal (ULN). Isolated bilirubin \>=1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); Alanine aminotransferase (ALT) \<=2.5X ULN; Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 meter square (mL/min/m\^2); Spot urine (albumin/creatinine ratios \[spot urine\]) \<500 milligram per gram (mg/g) (56 mg per millimoles \[mg/mmol\]); Left ventricular ejection fraction (LVEF) (Echocardiogram)\>=45 percent. * Female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 80 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Male participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 140 days: Refrain from donating sperm; Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a WOCBP who is not currently pregnant. * All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\]), version 4.03, must be \<=Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy. * For France only: A participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Systemic anti-myeloma therapy within \<=14 days, or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to the first dose of study drug. * Systemic treatment with high dose steroids (equivalent to \>=60 mg prednisone daily for \>=4 days) within the past 14 days if administered to treat MM or non-MM disease. * Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening. * Prior allogeneic stem cell transplant. * Current corneal epithelial disease except mild punctate keratopathy. * Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs. Prior B-cell maturation antigen (BCMA) targeted therapy. * Evidence of active mucosal or internal bleeding. * Any major surgery within the last four weeks. * Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GlaxoSmithKline Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled. * Evidence of cardiovascular risk including any of the following: Corrected QT interval Fridericia (QTcF) interval \>480 milliseconds (msec); Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA); Uncontrolled hypertension. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. * Pregnant or lactating female. * Active infection requiring antibiotic, antiviral, or antifungal treatment. * Known Human Immunodeficiency Virus (HIV) infection. * Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at screening or within 3 months prior to first dose of study treatment. * Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) | Up to 48 weeks | ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method. |
| Overall Response Rate by Independent Review Committee (Efficacy Population) | Up to 48 weeks | ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate by Investigator Assessment (Efficacy Population) | Up to 186 weeks | ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
| Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population) | Up to 186 weeks | CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
| Clinical Benefit Rate by Investigator Assessment (Efficacy Population) | Up to 186 weeks | CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
| Clinical Benefit Rate by Independent Review Committee (Full Analysis Population) | Up to 186 weeks | CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
| Clinical Benefit Rate by Independent Review Committee (Efficacy Population) | Up to 186 weeks | CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
| Duration of Response (DoR) by Investigator Assessment (Full Analysis Population) | Up to 186 weeks | DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented. |
| Duration of Response by Investigator Assessment (Efficacy Population) | Up to 186 weeks | DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented. |
| Duration of Response by Independent Review Committee (Full Analysis Population) | Up to 186 weeks | DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented. |
| Duration of Response by Independent Review Committee (Efficacy Population) | Up to 186 weeks | DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented. |
| Time to Response by Investigator Assessment (Full Analysis Population) | Up to 186 weeks | Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented. |
| Time to Response by Investigator Assessment (Efficacy Population) | Up to 186 weeks | Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented. |
| Time to Response by Independent Review Committee (Full Analysis Population) | Up to 186 weeks | Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented. |
| Time to Response by Independent Review Committee (Efficacy Population) | Up to 186 weeks | Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented. |
| Progression Free Survival by Investigator Assessment | Up to 186 weeks | Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented. |
| Progression Free Survival by Independent Review Committee | Up to 186 weeks | Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented. |
| Time to Progression by Investigator Assessment | Up to 186 weeks | Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented. |
| Time to Progression by Independent Review Committee | Up to 186 weeks | Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented. |
| Overall Survival | Up to 186 weeks | Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented. |
| Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baseline (Day 1) and Up to 186 weeks | Following parameters were assessed:basophils,eosinophils,hematocrit,mean corpuscular hemoglobin (MCH),MCH concentration,MC volume,monocyte,erythrocytes, reticulocytes.Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range\[LNR\]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and Up to 186 weeks | Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented. |
| Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Baseline (Day 1) and Up to 186 weeks | Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein,Urea enzymatic colorimetry.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP. |
| Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and Up to 186 weeks | Blood samples were collected for analysis of:glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil),creatinine kinase (CK),creatinine, gamma glutamyl transferase (GGT),potassium (Pot), magnesium (Mg),sodium (Sod), phosphate (Ph) urate & estimated glomerular filtration rate (eGFR). Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Grading was according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented.Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP. |
| Number of Participants With Abnormal Findings During Physical Examination | Up to 186 weeks | Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database. |
| Number of Participants With Change From Baseline in Pulse Rate | Baseline (Day 1) and Up to 186 weeks | Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to \<60 beats per minute \[bpm\]', 'increase to \>100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to \>100 bpm to increase to \>100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<60 bpm' and 'increased to \>100 bpm' during post Baseline. Data for worst-case post Baseline is presented. |
| Number of Participants With Change From Baseline in Body Temperature | Baseline (Day 1) and Up to 186 weeks | Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to \<=35 degrees celsius', 'increase to \>=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to \>=38 to increase to \>=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<=35' and 'increased to \>=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented. |
| Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) and Up to 186 weeks | SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: \<120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: \>=160 mmHg. For DBP: Grade 0: \<80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: \>=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented. |
| Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Up to 186 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented. |
| Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Baseline (Day 1) and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline \<0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from Baseline \>=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP \>=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) | Baseline and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented. |
| Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Baseline and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | Baseline and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Baseline and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Baseline and Up to 186 weeks | Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from \>10 seconds (Baseline) to \<=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment. |
| Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. |
| Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. |
| Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. |
| Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. |
| Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. |
| AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods. |
| AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days) | Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. |
| Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186 | The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Titers of Anti-drug Antibodies Against GSK2857916 | Up to 186 weeks | Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arm GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values was not presented for the arm. |
| Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to 186 weeks | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented. |
| Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score | Baseline (Day 1) and up to Week 186 | The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented. |
| Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | Baseline (Day 1) and up to Week 186 | The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented. |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186 | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result | Up to 186 weeks | Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA. |
| Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population) | Up to 186 weeks | ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off. |
Countries
Australia, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
This was an open-label, randomized, multicenter study to evaluate the efficacy and safety of belantamab mafodotin monotherapy at a dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg, given intravenously (IV) in participants with relapsed/refractory multiple myeloma (RRMM).
Pre-assignment details
A total of 221 participants were enrolled in this study. The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants benefiting from drug continued to receive study drug until discontinuation or withdrawal from study.
Participants by arm
| Arm | Count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. | 97 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. | 99 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection. | 25 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Main Study (Day 1 to 186 Weeks) | Death | 70 | 80 | 16 | 0 | 0 |
| Main Study (Day 1 to 186 Weeks) | Lost to Follow-up | 2 | 1 | 2 | 0 | 0 |
| Main Study (Day 1 to 186 Weeks) | other reasons | 14 | 10 | 5 | 0 | 0 |
| Main Study (Day 1 to 186 Weeks) | Physician Decision | 2 | 4 | 0 | 0 | 0 |
| Main Study (Day 1 to 186 Weeks) | Transitioned to PACT phase | 1 | 2 | 0 | 0 | 0 |
| Main Study (Day 1 to 186 Weeks) | Withdrawal by Subject | 8 | 2 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) |
|---|---|---|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 10.01 | 67.2 Years STANDARD_DEVIATION 10.78 | 66.0 Years STANDARD_DEVIATION 9.09 | 64.1 Years STANDARD_DEVIATION 10.01 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 30 Participants | 3 Participants | 11 Participants | 16 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Mixed Asian Race | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed White Race | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 6 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 176 Participants | 21 Participants | 83 Participants | 72 Participants |
| Sex: Female, Male Female | 100 Participants | 11 Participants | 43 Participants | 46 Participants |
| Sex: Female, Male Male | 121 Participants | 14 Participants | 56 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 70 / 97 | 80 / 99 | 16 / 25 | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 93 / 95 | 96 / 99 | 24 / 24 | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 43 / 95 | 53 / 99 | 15 / 24 | 1 / 1 | 2 / 2 |
Outcome results
Primary
Overall Response Rate by Independent Review Committee (Efficacy Population)
ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.
Time frame: Up to 48 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Overall Response Rate by Independent Review Committee (Efficacy Population) | 30 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Overall Response Rate by Independent Review Committee (Efficacy Population) | 30 Percentage of Participants |
Primary
Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.
Time frame: Up to 48 weeks
Population: Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) | 31 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) | 34 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) | 48 Percentage of Participants |
Secondary
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment.
Time frame: Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1,n=26,18,18 | 5644 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.6 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=19,21,9 | 7848 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.7 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1,n=26,18,18 | 6495 Hours*microgram per milliliter | Geometric Coefficient of Variation 54.3 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=19,21,9 | 9199 Hours*microgram per milliliter | Geometric Coefficient of Variation 45.1 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1,n=26,18,18 | 6962 Hours*microgram per milliliter | Geometric Coefficient of Variation 51.4 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=19,21,9 | 9694 Hours*microgram per milliliter | Geometric Coefficient of Variation 49.9 |
Secondary
Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 4607 Hours*microgram per milliliter | Geometric Coefficient of Variation 54.4 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=28,28,11 | 6033 Hours*microgram per milliliter | Geometric Coefficient of Variation 44.7 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 5567 Hours*microgram per milliliter | Geometric Coefficient of Variation 51 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=28,28,11 | 6084 Hours*microgram per milliliter | Geometric Coefficient of Variation 73.8 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 6293 Hours*microgram per milliliter | Geometric Coefficient of Variation 45.7 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=28,28,11 | 8388 Hours*microgram per milliliter | Geometric Coefficient of Variation 46.1 |
Secondary
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=30,20,22 | 4666 Hours*microgram per milliliter | Geometric Coefficient of Variation 45.7 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,24,11 | 6399 Hours*microgram per milliliter | Geometric Coefficient of Variation 31.6 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=30,20,22 | 5678 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.1 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,24,11 | 6941 Hours*microgram per milliliter | Geometric Coefficient of Variation 34.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=30,20,22 | 5946 Hours*microgram per milliliter | Geometric Coefficient of Variation 37.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,24,11 | 7593 Hours*microgram per milliliter | Geometric Coefficient of Variation 34.5 |
Secondary
AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
Secondary
AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=16,10,9 | 10268 Hours*microgram per milliliter | Geometric Coefficient of Variation 65.8 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=10,11,3 | 20526 Hours*microgram per milliliter | Geometric Coefficient of Variation 45.1 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=16,10,9 | 10209 Hours*microgram per milliliter | Geometric Coefficient of Variation 64.9 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=10,11,3 | 18637 Hours*microgram per milliliter | Geometric Coefficient of Variation 69.4 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=16,10,9 | 10170 Hours*microgram per milliliter | Geometric Coefficient of Variation 75 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=10,11,3 | 22782 Hours*microgram per milliliter | Geometric Coefficient of Variation 161.1 |
Secondary
AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours*nanogram per milliliter |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours*nanogram per milliliter |
Secondary
AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,18,19 | 7305 Hours*microgram per milliliter | Geometric Coefficient of Variation 41.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,24,11 | 11243 Hours*microgram per milliliter | Geometric Coefficient of Variation 34.6 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,18,19 | 9566 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.2 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,24,11 | 11646 Hours*microgram per milliliter | Geometric Coefficient of Variation 38 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,18,19 | 9029 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,24,11 | 15311 Hours*microgram per milliliter | Geometric Coefficient of Variation 43.9 |
Secondary
AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 79.26 Hours*nanogram per milliliter | Geometric Coefficient of Variation 61 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 70.84 Hours*nanogram per milliliter | Geometric Coefficient of Variation 46.9 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 113.57 Hours*nanogram per milliliter | Geometric Coefficient of Variation 58.3 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 74.04 Hours*nanogram per milliliter | Geometric Coefficient of Variation 73 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 100.35 Hours*nanogram per milliliter | Geometric Coefficient of Variation 51.8 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 69.83 Hours*nanogram per milliliter | Geometric Coefficient of Variation 36.6 |
Secondary
AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 7417 Hours*microgram per milliliter | Geometric Coefficient of Variation 58.5 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=27,26,11 | 10725 Hours*microgram per milliliter | Geometric Coefficient of Variation 59.4 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 9628 Hours*microgram per milliliter | Geometric Coefficient of Variation 52.8 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=27,26,11 | 11295 Hours*microgram per milliliter | Geometric Coefficient of Variation 80 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 9017 Hours*microgram per milliliter | Geometric Coefficient of Variation 55.4 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=27,26,11 | 17715 Hours*microgram per milliliter | Geometric Coefficient of Variation 61 |
Secondary
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186
Population: Full Analysis Population. Only those participants who were measured analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 61,n=11,11,3 | -2.1 Scores on a scale | Standard Deviation 12.32 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 97,n=4,5,3 | -12.5 Scores on a scale | Standard Deviation 15.3 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 31,n=14,18,7 | 2.4 Scores on a scale | Standard Deviation 20.52 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 43,n=15,13,4 | 8.1 Scores on a scale | Standard Deviation 21.19 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 79,n=3,2,2 | -16.7 Scores on a scale | Standard Deviation 11.11 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 37,n=14,13,5 | 9.5 Scores on a scale | Standard Deviation 27.51 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 19,n=18,25,10 | 3.7 Scores on a scale | Standard Deviation 22.87 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 61,n=11,11,3 | -11.6 Scores on a scale | Standard Deviation 12.29 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 43,n=15,13,4 | 4.4 Scores on a scale | Standard Deviation 24.77 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 43,n=15,13,4 | 1.0 Scores on a scale | Standard Deviation 8.81 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 43,n=15,13,4 | -5.9 Scores on a scale | Standard Deviation 12.51 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 61,n=11,11,3 | 10.1 Scores on a scale | Standard Deviation 18.89 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 37,n=14,13,5 | -6.0 Scores on a scale | Standard Deviation 12.22 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 186,n=39,46,16 | 4.0 Scores on a scale | Standard Deviation 10.98 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 31,n=14,18,7 | -3.6 Scores on a scale | Standard Deviation 10.59 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 97,n=4,5,3 | 8.3 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 37,n=14,13,5 | 2.2 Scores on a scale | Standard Deviation 6.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 25,n=19,23,7 | -0.0 Scores on a scale | Standard Deviation 16.25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 115,n=2,6,3 | -16.7 Scores on a scale | Standard Deviation 70.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 79,n=3,2,2 | -7.4 Scores on a scale | Standard Deviation 6.42 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 19,n=18,25,10 | 0.9 Scores on a scale | Standard Deviation 14.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 133,n=2,1,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 115,n=2,6,3 | 5.7 Scores on a scale | Standard Deviation 13.36 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 13,n=28,28,15 | -1.0 Scores on a scale | Standard Deviation 16.22 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 31,n=14,18,7 | 2.0 Scores on a scale | Standard Deviation 6.07 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 97,n=4,5,3 | 5.6 Scores on a scale | Standard Deviation 14.34 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 186,n=39,46,16 | -4.3 Scores on a scale | Standard Deviation 30.76 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 25,n=19,23,7 | 2.3 Scores on a scale | Standard Deviation 27.11 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 07,n=47,45,16 | -1.8 Scores on a scale | Standard Deviation 19.73 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 25,n=19,23,7 | 3.4 Scores on a scale | Standard Deviation 8.41 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 115,n=2,6,3 | 11.1 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 13,n=28,28,15 | -2.0 Scores on a scale | Standard Deviation 24.39 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 19,n=18,25,10 | 0.0 Scores on a scale | Standard Deviation 10.4 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 133,n=2,1,2 | 27.8 Scores on a scale | Standard Deviation 7.86 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 97,n=4,5,3 | -0.2 Scores on a scale | Standard Deviation 5.42 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 13,n=28,28,15 | 2.0 Scores on a scale | Standard Deviation 10.44 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 31,n=14,18,7 | 7.1 Scores on a scale | Standard Deviation 18.8 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 07,n=47,45,16 | 2.8 Scores on a scale | Standard Deviation 25.11 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 186,n=39,46,16 | -9.4 Scores on a scale | Standard Deviation 19.34 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 61,n=11,11,3 | 6.1 Scores on a scale | Standard Deviation 25.03 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 07,n=47,45,16 | 1.5 Scores on a scale | Standard Deviation 9.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 07,n=47,45,16 | 2.8 Scores on a scale | Standard Deviation 22.87 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 79,n=3,2,2 | 5.9 Scores on a scale | Standard Deviation 11.4 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 186, n=39,46,16 | -0.6 Scores on a scale | Standard Deviation 17.28 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 13,n=28,28,15 | 6.0 Scores on a scale | Standard Deviation 25.75 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 37,n=14,13,5 | 6.3 Scores on a scale | Standard Deviation 17.28 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 133,n=2,1,2 | -13.9 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 19,n=18,25,10 | 5.6 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 133,n=2,1,2 | 5.7 Scores on a scale | Standard Deviation 13.36 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 115,n=2,6,3 | -19.4 Scores on a scale | Standard Deviation 3.93 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 25,n=19,23,7 | 7.0 Scores on a scale | Standard Deviation 23.78 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 186,n=39,46,16 | -7.7 Scores on a scale | Standard Deviation 26.69 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 07,n=47,45,16 | 4.2 Scores on a scale | Standard Deviation 29.99 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 13,n=28,28,15 | 8.3 Scores on a scale | Standard Deviation 22.55 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 19,n=18,25,10 | 10.7 Scores on a scale | Standard Deviation 20.91 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 25,n=19,23,7 | 13.5 Scores on a scale | Standard Deviation 29.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 31,n=14,18,7 | 19.1 Scores on a scale | Standard Deviation 24.93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 37,n=14,13,5 | 29.1 Scores on a scale | Standard Deviation 22.47 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 43,n=15,13,4 | 29.9 Scores on a scale | Standard Deviation 26.98 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 61,n=11,11,3 | 4.0 Scores on a scale | Standard Deviation 20.65 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 79,n=3,2,2 | 33.3 Scores on a scale | Standard Deviation 31.43 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 97,n=4,5,3 | 17.8 Scores on a scale | Standard Deviation 39.75 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 115,n=2,6,3 | 16.7 Scores on a scale | Standard Deviation 25.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 133,n=2,1,2 | 55.6 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 151,n=0,2,0 | 44.4 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 169,n=0,1,0 | 55.6 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 07,n=47,45,16 | 9.6 Scores on a scale | Standard Deviation 28.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 13,n=28,28,15 | 6.0 Scores on a scale | Standard Deviation 35.2 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 19,n=18,25,10 | 8.0 Scores on a scale | Standard Deviation 25.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 25,n=19,23,7 | 15.9 Scores on a scale | Standard Deviation 31.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 31,n=14,18,7 | 14.8 Scores on a scale | Standard Deviation 30.73 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 37,n=14,13,5 | 25.6 Scores on a scale | Standard Deviation 30.89 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 43,n=15,13,4 | 28.2 Scores on a scale | Standard Deviation 38.12 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 61,n=11,11,3 | 12.1 Scores on a scale | Standard Deviation 26.97 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 97,n=4,5,3 | 6.7 Scores on a scale | Standard Deviation 27.89 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 115,n=2,6,3 | 5.6 Scores on a scale | Standard Deviation 25.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 151,n=0,2,0 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 186,n=39,46,16 | -0.7 Scores on a scale | Standard Deviation 35.48 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 07,n=47,45,16 | -1.0 Scores on a scale | Standard Deviation 17.78 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 13,n=28,28,15 | -3.2 Scores on a scale | Standard Deviation 22.95 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 19,n=18,25,10 | -6.4 Scores on a scale | Standard Deviation 17.98 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 25,n=19,23,7 | -3.6 Scores on a scale | Standard Deviation 17.78 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 31,n=14,18,7 | -10.5 Scores on a scale | Standard Deviation 19.23 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 37,n=14,13,5 | -9.8 Scores on a scale | Standard Deviation 22.92 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 43,n=15,13,4 | -14.5 Scores on a scale | Standard Deviation 24.06 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 61,n=11,11,3 | -7.6 Scores on a scale | Standard Deviation 10.02 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 79,n=3,2,2 | -2.8 Scores on a scale | Standard Deviation 3.93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 97,n=4,5,3 | -3.3 Scores on a scale | Standard Deviation 15.52 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 115,n=2,6,3 | -7.4 Scores on a scale | Standard Deviation 10.92 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 133,n=2,1,2 | -5.6 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 151,n=0,2,0 | 5.6 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 169,n=0,1,0 | -5.6 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 186, n=39,46,16 | 2.5 Scores on a scale | Standard Deviation 18.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 07,n=47,45,16 | 0.4 Scores on a scale | Standard Deviation 13.33 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 13,n=28,28,15 | -1.7 Scores on a scale | Standard Deviation 11.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 19,n=18,25,10 | -1.2 Scores on a scale | Standard Deviation 10.87 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 25,n=19,23,7 | 0.1 Scores on a scale | Standard Deviation 13.1 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 31,n=14,18,7 | -2.9 Scores on a scale | Standard Deviation 13.87 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 37,n=14,13,5 | -6.0 Scores on a scale | Standard Deviation 17.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 43,n=15,13,4 | -5.6 Scores on a scale | Standard Deviation 19.05 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 61,n=11,11,3 | 1.9 Scores on a scale | Standard Deviation 12.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 133,n=2,1,2 | -7.4 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 79,n=3,2,2 | 9.1 Scores on a scale | Standard Deviation 12.83 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 97,n=4,5,3 | 5.0 Scores on a scale | Standard Deviation 13.8 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 115,n=2,6,3 | 0.7 Scores on a scale | Standard Deviation 7.21 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 169,n=0,1,0 | -11.1 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 186,n=39,46,16 | 4.0 Scores on a scale | Standard Deviation 12.61 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 19,n=18,25,10 | -3.3 Scores on a scale | Standard Deviation 42.89 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 37,n=14,13,5 | 11.1 Scores on a scale | Standard Deviation 31.43 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 115,n=2,6,3 | -10.0 Scores on a scale | Standard Deviation 16.59 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 13,n=28,28,15 | -4.4 Scores on a scale | Standard Deviation 37.52 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 115,n=2,6,3 | -1.0 Scores on a scale | Standard Deviation 7.09 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 133,n=2,1,2 | 8.3 Scores on a scale | Standard Deviation 51.07 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 61,n=11,11,3 | 2.0 Scores on a scale | Standard Deviation 9.84 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 13,n=28,28,15 | -2.2 Scores on a scale | Standard Deviation 27.28 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 07,n=47,45,16 | 4.2 Scores on a scale | Standard Deviation 43.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 31,n=14,18,7 | 7.9 Scores on a scale | Standard Deviation 27 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 186, n=39,46,16 | 4.9 Scores on a scale | Standard Deviation 24.5 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 186,n=39,46,16 | 3.5 Scores on a scale | Standard Deviation 24.59 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 133,n=2,1,2 | -8.1 Scores on a scale | Standard Deviation 5.24 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 07,n=47,45,16 | 0.2 Scores on a scale | Standard Deviation 15.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 133,n=2,1,2 | 38.9 Scores on a scale | Standard Deviation 55 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 79,n=3,2,2 | -1.3 Scores on a scale | Standard Deviation 4.45 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 13,n=28,28,15 | 6.8 Scores on a scale | Standard Deviation 23.69 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 115,n=2,6,3 | 33.3 Scores on a scale | Standard Deviation 58.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 25,n=19,23,7 | 4.8 Scores on a scale | Standard Deviation 31.98 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 19,n=18,25,10 | 0.9 Scores on a scale | Standard Deviation 9.04 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 97,n=4,5,3 | 22.2 Scores on a scale | Standard Deviation 40.06 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 07,n=47,45,16 | 8.3 Scores on a scale | Standard Deviation 24.51 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 186,n=39,46,16 | 10.4 Scores on a scale | Standard Deviation 41.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 25,n=19,23,7 | 0.4 Scores on a scale | Standard Deviation 6.45 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 07,n=47,45,16 | -2.8 Scores on a scale | Standard Deviation 12.17 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 133,n=2,1,2 | 83.3 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 79,n=3,2,2 | 38.9 Scores on a scale | Standard Deviation 39.28 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 13,n=28,28,15 | 1.1 Scores on a scale | Standard Deviation 25.65 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 115,n=2,6,3 | 55.6 Scores on a scale | Standard Deviation 50.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 97,n=4,5,3 | -4.7 Scores on a scale | Standard Deviation 3.44 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 19,n=18,25,10 | -1.7 Scores on a scale | Standard Deviation 20.63 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 97,n=4,5,3 | 44.4 Scores on a scale | Standard Deviation 69.39 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 31,n=14,18,7 | 5.5 Scores on a scale | Standard Deviation 11.12 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 25,n=19,23,7 | -1.6 Scores on a scale | Standard Deviation 25.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 79,n=3,2,2 | 33.3 Scores on a scale | Standard Deviation 94.28 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 61,n=11,11,3 | 25.9 Scores on a scale | Standard Deviation 54.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 31,n=14,18,7 | -4.8 Scores on a scale | Standard Deviation 23.88 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 61,n=11,11,3 | 33.3 Scores on a scale | Standard Deviation 57.74 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 19,n=18,25,10 | 3.3 Scores on a scale | Standard Deviation 27.24 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 37,n=14,13,5 | -14.4 Scores on a scale | Standard Deviation 16.01 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 79,n=3,2,2 | -2.8 Scores on a scale | Standard Deviation 27.5 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 43,n=15,13,4 | 8.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 37,n=14,13,5 | -1.8 Scores on a scale | Standard Deviation 4.04 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 43,n=15,13,4 | -8.3 Scores on a scale | Standard Deviation 26.64 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 37,n=14,13,5 | 26.7 Scores on a scale | Standard Deviation 54.77 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | FP,Week 43,n=15,13,4 | 8.3 Scores on a scale | Standard Deviation 5.56 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 61,n=11,11,3 | -11.1 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 31,n=14,18,7 | 9.5 Scores on a scale | Standard Deviation 56.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 186,n=39,46,16 | 3.7 Scores on a scale | Standard Deviation 10.75 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | BI,Week 25,n=19,23,7 | 9.5 Scores on a scale | Standard Deviation 53.45 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | SET,Week 43,n=15,13,4 | -4.9 Scores on a scale | Standard Deviation 5.76 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score | DS,Week 97,n=4,5,3 | -7.4 Scores on a scale | Standard Deviation 25.05 |
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186
Population: Full Analysis Population. Only those participants who were measured analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 25, n=20, 23, 7 | -4.6 Scores on a scale | Standard Deviation 21.2 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 186,n=41,46, 17 | 1.6 Scores on a scale | Standard Deviation 27.59 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 07,n=48,47,17 | -2.1 Scores on a scale | Standard Deviation 22.18 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 25,n=20,23,7 | -4.6 Scores on a scale | Standard Deviation 16.1 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 13,n=29,29,16 | -1.1 Scores on a scale | Standard Deviation 18.86 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 31, n=15,18, 7 | 2.2 Scores on a scale | Standard Deviation 19.53 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 19,n=19,27,10 | -5.3 Scores on a scale | Standard Deviation 20.07 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 25,n=20,23,7 | -1.7 Scores on a scale | Standard Deviation 20.16 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 13, n=29,29,16 | 0.7 Scores on a scale | Standard Deviation 14.62 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 31,n=15, 18, 7 | -6.7 Scores on a scale | Standard Deviation 18.69 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 37, n=15,13, 5 | 1.7 Scores on a scale | Standard Deviation 13.44 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 37,n=15, 13, 5 | -8.9 Scores on a scale | Standard Deviation 19.79 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 43,n=15, 14, 4 | -6.7 Scores on a scale | Standard Deviation 22.54 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 43, n=15,14, 4 | 0.0 Scores on a scale | Standard Deviation 18.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 79,n=3, 2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 97,n=4, 5,3 | 16.7 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 37,n=15,13,5 | -1.7 Scores on a scale | Standard Deviation 14.5 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 115,n=2, 6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 61, n=11,11, 3 | 6.8 Scores on a scale | Standard Deviation 12.81 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 133,n=2,1,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 186,n=41, 46,17 | 0.0 Scores on a scale | Standard Deviation 19.72 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 19,n=19,27,10 | 0.4 Scores on a scale | Standard Deviation 13.78 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 07,n=48, 47, 17 | -6.2 Scores on a scale | Standard Deviation 29.7 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 79, n=3,2,2 | 2.8 Scores on a scale | Standard Deviation 4.81 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 13,n=29,29,16 | 0.0 Scores on a scale | Standard Deviation 26.73 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 19,n=19,27,10 | -8.8 Scores on a scale | Standard Deviation 24.45 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 25,n=20,23,7 | -5.0 Scores on a scale | Standard Deviation 32.94 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 97, n=4,5,3 | 2.1 Scores on a scale | Standard Deviation 10.49 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 31,n=15,18,7 | -17.8 Scores on a scale | Standard Deviation 27.79 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 37,n=15,13,5 | -15.6 Scores on a scale | Standard Deviation 33.01 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 43,n=15,14,4 | -15.6 Scores on a scale | Standard Deviation 30.52 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 115, n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 61,n=11,11,3 | -9.1 Scores on a scale | Standard Deviation 15.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 25, n=20,23,7 | 1.3 Scores on a scale | Standard Deviation 12.16 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 97,n=4,5,3 | -25.0 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 133, n=2,1,2 | -4.2 Scores on a scale | Standard Deviation 29.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 115,n=2,6,3 | -33.3 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 133,n=2,1,2 | -16.7 Scores on a scale | Standard Deviation 70.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 186,n=41,46,17 | 2.4 Scores on a scale | Standard Deviation 33.66 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 07,n=48,47,17 | 4.9 Scores on a scale | Standard Deviation 24.78 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 13,n=29,29,16 | 8.0 Scores on a scale | Standard Deviation 29.08 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 186, n=41,46,17 | -6.7 Scores on a scale | Standard Deviation 24.45 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 19,n=19,27,10 | 0.0 Scores on a scale | Standard Deviation 24.85 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 25,n=20, 23, 7 | 6.7 Scores on a scale | Standard Deviation 31.72 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 31,n=15,18, 7 | -8.9 Scores on a scale | Standard Deviation 15.26 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 07,n=48,47,17 | 4.5 Scores on a scale | Standard Deviation 20.55 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 13,n=29,29,16 | 0.0 Scores on a scale | Standard Deviation 25.2 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 37,n=15,13,5 | -4.4 Scores on a scale | Standard Deviation 17.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 19,n=19,27,10 | 1.8 Scores on a scale | Standard Deviation 26 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 31,n=15,18,7 | -2.7 Scores on a scale | Standard Deviation 8.66 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 43,n=15,14,4 | -4.4 Scores on a scale | Standard Deviation 17.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 13,n=29,29,16 | 2.3 Scores on a scale | Standard Deviation 23.45 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 61,n=11,11,3 | -6.1 Scores on a scale | Standard Deviation 20.1 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 79,n=3,2,2 | -33.3 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 97, n=4,5,3 | -4.2 Scores on a scale | Standard Deviation 43.83 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 25,n=20,23,7 | 3.3 Scores on a scale | Standard Deviation 28.41 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 31,n=15,18,7 | -2.2 Scores on a scale | Standard Deviation 23.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 43,n=15,14,4 | -4.4 Scores on a scale | Standard Deviation 14.04 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 37,n=15,13,5 | -2.2 Scores on a scale | Standard Deviation 23.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 43,n=15,14,4 | -4.4 Scores on a scale | Standard Deviation 21.33 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 37,n=15,13, 5 | 4.0 Scores on a scale | Standard Deviation 11.76 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 115, n=2,6,3 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 97,n=4,5,3 | -8.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 133, n=2,1,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 133,n=2,1,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 186,n=41,46,17 | -0.8 Scores on a scale | Standard Deviation 21.72 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 19,n=19,27,10 | -1.8 Scores on a scale | Standard Deviation 26.58 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 07,n=48,47,17 | -4.9 Scores on a scale | Standard Deviation 25.72 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 13,n=29,29,16 | -4.6 Scores on a scale | Standard Deviation 23.1 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 97,n=4,5,3 | -8.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 19,n=19,27,10 | -7.0 Scores on a scale | Standard Deviation 21.02 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 25, n=20, 23, 7 | -1.7 Scores on a scale | Standard Deviation 27.52 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 25,n=20,23,7 | -3.3 Scores on a scale | Standard Deviation 26.27 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 43,n=15,14, 4 | 3.1 Scores on a scale | Standard Deviation 11.23 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 31,n=15,18, 7 | -6.7 Scores on a scale | Standard Deviation 22.54 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 31, n=15,18, 7 | 6.7 Scores on a scale | Standard Deviation 23.4 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 37,n=15,13,5 | -2.2 Scores on a scale | Standard Deviation 23.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 43,n=15,14,4 | -6.7 Scores on a scale | Standard Deviation 18.69 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 61,n=11,11,3 | -12.1 Scores on a scale | Standard Deviation 37.34 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 37, n=15,13, 5 | 3.3 Scores on a scale | Standard Deviation 22 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 79,n=3,2,1 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 97,n=4,5,3 | -25.0 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 13,n=29,29,16 | -3.2 Scores on a scale | Standard Deviation 18.42 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 43, n=15,14, 4 | 2.2 Scores on a scale | Standard Deviation 24.29 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 133,n=2,1,2 | -50.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 186,n=41,46,17 | -1.6 Scores on a scale | Standard Deviation 24.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 07,n=48,47,17 | -0.7 Scores on a scale | Standard Deviation 20.47 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 61,n=11,11, 3 | 4.2 Scores on a scale | Standard Deviation 12.39 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 61, n=11,11, 3 | 10.6 Scores on a scale | Standard Deviation 27.15 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 79, n=3,2,2 | 11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 61,n=11,11,3 | -3.8 Scores on a scale | Standard Deviation 17.23 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 79,n=3,2, 2 | 2.2 Scores on a scale | Standard Deviation 3.85 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 186, n=41,46,17 | -4.1 Scores on a scale | Standard Deviation 26.56 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 97, n=4,5,3 | -4.2 Scores on a scale | Standard Deviation 25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 115, n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 97,n=4,5, 3 | 0.0 Scores on a scale | Standard Deviation 9.43 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 07,n=48,47,17 | -3.7 Scores on a scale | Standard Deviation 21.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 13,n=29,29,16 | -7.7 Scores on a scale | Standard Deviation 23.78 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 133, n=2,1,2 | -8.3 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 31,n=15,18,7 | -2.2 Scores on a scale | Standard Deviation 14.59 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 186, n=41,46,17 | -3.3 Scores on a scale | Standard Deviation 25.88 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 115,n=2,6, 3 | 3.3 Scores on a scale | Standard Deviation 4.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 19,n=19,27,10 | -0.6 Scores on a scale | Standard Deviation 22.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 07,n=48,47,17 | 3.8 Scores on a scale | Standard Deviation 29.02 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 79,n=3,2,1 | 2.8 Scores on a scale | Standard Deviation 24.06 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 25, n=20, 23, 7 | 3.3 Scores on a scale | Standard Deviation 23.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 133,n=2,1, 2 | 3.3 Scores on a scale | Standard Deviation 4.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 31, n=15,18, 7 | -0.7 Scores on a scale | Standard Deviation 21.61 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 13,n=29,29,16 | -4.0 Scores on a scale | Standard Deviation 28.75 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 19,n=19,27,10 | -6.1 Scores on a scale | Standard Deviation 28.44 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 25, n=20, 23, 7 | -6.7 Scores on a scale | Standard Deviation 26.71 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 31, n=15,18, 7 | 2.2 Scores on a scale | Standard Deviation 16.51 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 186,n=41,46,17 | -0.8 Scores on a scale | Standard Deviation 21.2 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 37, n=15,13, 5 | -9.6 Scores on a scale | Standard Deviation 18.24 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 133,n=2,1,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 37, n=15,13, 5 | 2.2 Scores on a scale | Standard Deviation 21.7 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 07,n=48,47,17 | 0.3 Scores on a scale | Standard Deviation 33.24 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 43, n=15,14, 4 | -1.1 Scores on a scale | Standard Deviation 17.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 61, n=11,11, 3 | 7.6 Scores on a scale | Standard Deviation 32.8 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 97,n=4,5,3 | 8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 79, n=3,2,2 | 5.6 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 13,n=29,29,16 | 2.3 Scores on a scale | Standard Deviation 33.55 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 43, n=15,14, 4 | -12.6 Scores on a scale | Standard Deviation 17.25 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 61, n=11,11, 3 | -12.1 Scores on a scale | Standard Deviation 24.07 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 79, n=3,2,2 | -22.2 Scores on a scale | Standard Deviation 11.11 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 19,n=19,27,10 | -4.4 Scores on a scale | Standard Deviation 31.35 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 97, n=4,5,3 | -5.6 Scores on a scale | Standard Deviation 26.45 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 186,n=41,46,17 | 5.7 Scores on a scale | Standard Deviation 24.61 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 07,n=48,47,17 | 1.4 Scores on a scale | Standard Deviation 22.76 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 19,n=19,27,10 | -2.2 Scores on a scale | Standard Deviation 13.84 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 13,n=29,29,16 | 0.0 Scores on a scale | Standard Deviation 25.2 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 25,n=20,23,7 | 2.5 Scores on a scale | Standard Deviation 32.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 19,n=19,27,10 | -7.0 Scores on a scale | Standard Deviation 21.02 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 25,n=20,23,7 | -3.3 Scores on a scale | Standard Deviation 14.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 115,n=2,6,3 | -4.2 Scores on a scale | Standard Deviation 17.68 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 31,n=15,18,7 | -4.4 Scores on a scale | Standard Deviation 11.73 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 31,n=15,18,7 | 8.9 Scores on a scale | Standard Deviation 24.29 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 37,n=15,13,5 | 2.2 Scores on a scale | Standard Deviation 23.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 43,n=15,14,4 | -4.4 Scores on a scale | Standard Deviation 17.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 14.91 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 37,n=15,13,5 | 8.9 Scores on a scale | Standard Deviation 29.46 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 97,n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 43,n=15,14,4 | 8.9 Scores on a scale | Standard Deviation 30.12 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 133,n=2,1,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 186,n=41,46,17 | 5.7 Scores on a scale | Standard Deviation 20.95 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 133,n=2,1,2 | -4.2 Scores on a scale | Standard Deviation 17.68 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 07,n=48,47,17 | -2.8 Scores on a scale | Standard Deviation 26.48 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 61,n=11,11,3 | 12.1 Scores on a scale | Standard Deviation 36.58 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 115, n=2,6,3 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 133, n=2,1,2 | -5.6 Scores on a scale | Standard Deviation 39.28 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 79,n=3,2,2 | 5.6 Scores on a scale | Standard Deviation 34.69 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 186, n=41,46,17 | -1.6 Scores on a scale | Standard Deviation 23.12 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 07,n=48,47,17 | 2.4 Scores on a scale | Standard Deviation 14.17 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 13,n=29,29,16 | 2.3 Scores on a scale | Standard Deviation 13.16 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 97,n=4,5,3 | -4.2 Scores on a scale | Standard Deviation 43.83 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 19,n=19,27,10 | -1.8 Scores on a scale | Standard Deviation 15.61 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 25,n=20,23,7 | 5.0 Scores on a scale | Standard Deviation 12.21 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 31,n=15,18,7 | -3.3 Scores on a scale | Standard Deviation 6.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 37,n=15,13, 5 | -6.7 Scores on a scale | Standard Deviation 16.43 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 43,n=15,14,4 | -7.8 Scores on a scale | Standard Deviation 15.26 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 61, n=11,11,3 | -4.5 Scores on a scale | Standard Deviation 10.78 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 133,n=2,1,2 | 8.3 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 79, n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 97, n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 186n=41,46,17 | -8.1 Scores on a scale | Standard Deviation 19.5 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 115, n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 133, n=2,1,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V, Week 186, n=41,46,17 | 5.7 Scores on a scale | Standard Deviation 24.04 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 186,n=41,46,17 | -0.4 Scores on a scale | Standard Deviation 30.84 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 07,n=48,47,17 | -3.1 Scores on a scale | Standard Deviation 28.69 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 13,n=29,28,16 | -4.0 Scores on a scale | Standard Deviation 26.97 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 19,n=19,27,10 | 4.4 Scores on a scale | Standard Deviation 19.12 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 07,n=48,47,17 | 1.4 Scores on a scale | Standard Deviation 18.86 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 25,n=20,23,7 | 2.5 Scores on a scale | Standard Deviation 18.16 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 31,n=15,18,7 | 4.4 Scores on a scale | Standard Deviation 19.38 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 37,n=15,13,5 | -2.2 Scores on a scale | Standard Deviation 21.7 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 13,n=29,29,16 | -2.0 Scores on a scale | Standard Deviation 23 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 43,n=15,14,4 | -2.2 Scores on a scale | Standard Deviation 15.26 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 61,n=11,11,3 | -10.6 Scores on a scale | Standard Deviation 18.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 07,n=48,47,17 | 4.4 Scores on a scale | Standard Deviation 15.7 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 79,n=3,2,2 | -16.7 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 19,n=19,27,10 | 0.4 Scores on a scale | Standard Deviation 19.93 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 97,n=4,5,3 | -4.2 Scores on a scale | Standard Deviation 20.97 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 115,n=2,6, 3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 133,n=2,1, 2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 151,n=0,2, 0 | 33.3 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 133, n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 61, n=11,11, 3 | -1.5 Scores on a scale | Standard Deviation 15.73 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 61,n=11,11, 3 | 9.7 Scores on a scale | Standard Deviation 22.18 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 79, n=3,2,2 | -25.0 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 43,n=15,14,4 | 11.9 Scores on a scale | Standard Deviation 32.31 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 151, n=0,2,0 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 169, n=0,1,0 | 33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 186, n=41,46,17 | -10.1 Scores on a scale | Standard Deviation 25.93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 97, n=4,5,3 | -16.7 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 79,n=3,2, 2 | 10.0 Scores on a scale | Standard Deviation 4.71 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 186,n=41,46,17 | 3.6 Scores on a scale | Standard Deviation 20.16 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 115, n=2,6,3 | -0.0 Scores on a scale | Standard Deviation 18.26 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 61,n=11,11,3 | -5.3 Scores on a scale | Standard Deviation 13.58 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V, Week 151, n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V, Week 169, n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 07,n=48,47,17 | -0.5 Scores on a scale | Standard Deviation 23.74 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 97,n=4,5, 3 | 0.0 Scores on a scale | Standard Deviation 9.43 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 07,n=48,47,17 | -0.0 Scores on a scale | Standard Deviation 28.66 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 97,n=4,5,3 | 26.7 Scores on a scale | Standard Deviation 22.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 133, n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 97, n=4,5,3 | 6.7 Scores on a scale | Standard Deviation 20.18 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 151, n=0,2,0 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 169, n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 61,n=11,11,3 | -3.0 Scores on a scale | Standard Deviation 29.64 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 186, n=41,46,17 | -11.2 Scores on a scale | Standard Deviation 26.07 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 13,n=29,29,16 | -7.7 Scores on a scale | Standard Deviation 19.27 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 169,n=0,1, 0 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V, Week 186, n=41,46,17 | 3.3 Scores on a scale | Standard Deviation 18.47 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 186,n=41,46, 17 | 1.4 Scores on a scale | Standard Deviation 25.29 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 25, n=20, 23, 7 | 4.0 Scores on a scale | Standard Deviation 20.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 115, n=2,6,3 | -3.7 Scores on a scale | Standard Deviation 15.18 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 07,n=48,47,17 | 2.1 Scores on a scale | Standard Deviation 14.59 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 19,n=19,27,10 | -2.9 Scores on a scale | Standard Deviation 22.77 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 115,n=2,6, 3 | 4.4 Scores on a scale | Standard Deviation 13.11 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 13,n=29,29,16 | 1.1 Scores on a scale | Standard Deviation 22.68 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 133,n=2,1,2 | 33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 43,n=15,14,4 | -8.3 Scores on a scale | Standard Deviation 24.24 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 19,n=19,27,10 | 3.7 Scores on a scale | Standard Deviation 25.04 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 31, n=15,18, 7 | 0.9 Scores on a scale | Standard Deviation 25.06 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 133, n=2,1,2 | -22.2 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 25,n=20,23,7 | 4.3 Scores on a scale | Standard Deviation 18.27 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 25, n=20, 23, 7 | -2.4 Scores on a scale | Standard Deviation 21.7 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 13,n=29,29,16 | -0.0 Scores on a scale | Standard Deviation 25 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 31,n=15, 18, 7 | 0.0 Scores on a scale | Standard Deviation 16.17 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 151, n=0,2,0 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 31, n=15,18, 7 | -11.7 Scores on a scale | Standard Deviation 22.05 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 37,n=15, 13, 5 | 12.8 Scores on a scale | Standard Deviation 16.88 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 37, n=15,13, 5 | 9.6 Scores on a scale | Standard Deviation 23.29 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 07,n=48,47,17 | 1.1 Scores on a scale | Standard Deviation 32.49 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 43,n=15, 14, 4 | 2.4 Scores on a scale | Standard Deviation 15.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 13, n=29,29,16 | 4.1 Scores on a scale | Standard Deviation 11.19 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 133,n=2,1, 2 | 13.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 61,n=11,11,3 | 3.0 Scores on a scale | Standard Deviation 17.98 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 169, n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 13,n=29,29,16 | 1.7 Scores on a scale | Standard Deviation 28.64 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 79,n=3, 2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 43, n=15,14, 4 | 8.3 Scores on a scale | Standard Deviation 27.74 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 07,n=48,47,17 | -1.1 Scores on a scale | Standard Deviation 28.32 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 97,n=4, 5,3 | 0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 19,n=19,27,10 | 5.6 Scores on a scale | Standard Deviation 28.5 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 79,n=3,2,1 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 115,n=2, 6,3 | 5.6 Scores on a scale | Standard Deviation 13.61 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 186, n=41,46,17 | 4.1 Scores on a scale | Standard Deviation 23.35 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 25, n=20, 23, 7 | 13.8 Scores on a scale | Standard Deviation 22.84 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 61, n=11,11, 3 | -5.3 Scores on a scale | Standard Deviation 16.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 18.86 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 186,n=41, 46,17 | 12.3 Scores on a scale | Standard Deviation 24.7 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 79,n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 31, n=15,18, 7 | 15.7 Scores on a scale | Standard Deviation 31.56 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 07,n=48, 47, 17 | -2.8 Scores on a scale | Standard Deviation 26.77 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 186,n=41,46,17 | -8.3 Scores on a scale | Standard Deviation 33.66 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 13,n=29,29,16 | -1.1 Scores on a scale | Standard Deviation 25.95 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 79, n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 169, n=0,1,0 | 13.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 19,n=19,27,10 | -4.9 Scores on a scale | Standard Deviation 28.8 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 19,n=19,27,10 | 6.2 Scores on a scale | Standard Deviation 24.87 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 07,n=48,47,17 | 4.3 Scores on a scale | Standard Deviation 17.88 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 25,n=20,23,7 | -7.2 Scores on a scale | Standard Deviation 22.38 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 19,n=19,27,10 | 3.7 Scores on a scale | Standard Deviation 20.19 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 19,n=19,27,10 | 3.1 Scores on a scale | Standard Deviation 20.3 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 31,n=15,18,7 | -9.3 Scores on a scale | Standard Deviation 33.93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 97, n=4,5,3 | 1.7 Scores on a scale | Standard Deviation 25.95 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 37,n=15,13,5 | -10.3 Scores on a scale | Standard Deviation 16.01 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 37,n=15,13,5 | 1.9 Scores on a scale | Standard Deviation 21.29 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 186,n=41,46,17 | -6.2 Scores on a scale | Standard Deviation 21.29 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 43,n=15,14,4 | -4.8 Scores on a scale | Standard Deviation 22.1 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 13,n=29,29,16 | 6.0 Scores on a scale | Standard Deviation 16.5 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 13,n=29,29,16 | 1.1 Scores on a scale | Standard Deviation 9.89 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 61,n=11,11,3 | -9.1 Scores on a scale | Standard Deviation 21.56 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 115, n=2,6,3 | -2.8 Scores on a scale | Standard Deviation 11.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 151,n=0,2,0 | 33.3 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 79,n=3,2,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 37, n=15,13, 5 | 16.7 Scores on a scale | Standard Deviation 29.66 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 97,n=4,5,3 | -6.7 Scores on a scale | Standard Deviation 14.91 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 13,n=29,28,16 | -2.3 Scores on a scale | Standard Deviation 25.48 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 186n=41,46,17 | -11.6 Scores on a scale | Standard Deviation 22.46 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 115,n=2,6,3 | 5.6 Scores on a scale | Standard Deviation 25.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 133, n=2,1,2 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 43, n=15,14, 4 | 20.2 Scores on a scale | Standard Deviation 30.08 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 25, n=20,23,7 | 5.5 Scores on a scale | Standard Deviation 25.08 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 07,n=48,47,17 | -6.0 Scores on a scale | Standard Deviation 35.68 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 186,n=41,46,17 | -2.9 Scores on a scale | Standard Deviation 32.07 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 151, n=0,2,0 | 4.2 Scores on a scale | Standard Deviation 29.46 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 19,n=19,27,10 | -1.2 Scores on a scale | Standard Deviation 15.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 07,n=48,47,17 | 2.1 Scores on a scale | Standard Deviation 29 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 169, n=0,1,0 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 61, n=11,11, 3 | -1.5 Scores on a scale | Standard Deviation 17.41 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 13,n=29,29,16 | -2.3 Scores on a scale | Standard Deviation 25.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 97,n=4,5,3 | -6.7 Scores on a scale | Standard Deviation 19 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 61,n=11,11,3 | -0.0 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 19,n=19,27,10 | -0.0 Scores on a scale | Standard Deviation 38.12 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 186, n=41,46,17 | -6.2 Scores on a scale | Standard Deviation 21.04 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 79, n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 25,n=20, 23, 7 | -5.8 Scores on a scale | Standard Deviation 21.68 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 25,n=20,23,7 | -2.5 Scores on a scale | Standard Deviation 20.94 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 37, n=15,13, 5 | -13.7 Scores on a scale | Standard Deviation 24.07 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 31,n=15,18, 7 | 0.0 Scores on a scale | Standard Deviation 19.8 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 25,n=20,23,7 | -0.7 Scores on a scale | Standard Deviation 12.79 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 151,n=0,2,0 | 8.3 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 13,n=29,29,16 | -6.9 Scores on a scale | Standard Deviation 18.64 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 07,n=48,47,17 | -2.1 Scores on a scale | Standard Deviation 21.03 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 43, n=15,14, 4 | -10.3 Scores on a scale | Standard Deviation 32.16 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 37,n=15,13,5 | -5.1 Scores on a scale | Standard Deviation 22.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 13,n=29,29,16 | -0.6 Scores on a scale | Standard Deviation 32.88 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 19,n=19,27,10 | -2.5 Scores on a scale | Standard Deviation 24.33 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 19,n=19,27,10 | -8.6 Scores on a scale | Standard Deviation 31.14 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 61, n=11,11, 3 | 3.0 Scores on a scale | Standard Deviation 22.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 43,n=15,14,4 | -9.5 Scores on a scale | Standard Deviation 24.21 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 97,n=4,5,3 | 1.7 Scores on a scale | Standard Deviation 25.28 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 31,n=15,18,7 | 1.9 Scores on a scale | Standard Deviation 7.86 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 36.51 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 31,n=15,18,7 | 9.3 Scores on a scale | Standard Deviation 22.88 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 79, n=3,2,2 | -16.7 Scores on a scale | Standard Deviation 7.86 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 79,n=3,2,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 133,n=2,1, 2 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 115,n=2,6, 3 | 8.3 Scores on a scale | Standard Deviation 27.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 25,n=20,23,7 | -7.2 Scores on a scale | Standard Deviation 33.27 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 13,n=29,29,16 | -1.1 Scores on a scale | Standard Deviation 15.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 37,n=15,13, 5 | 2.6 Scores on a scale | Standard Deviation 11.48 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 31,n=15,18,7 | -3.7 Scores on a scale | Standard Deviation 34.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 186,n=41,46,17 | -0.0 Scores on a scale | Standard Deviation 32.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 19,n=19,27,10 | 1.9 Scores on a scale | Standard Deviation 36.5 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 37,n=15,13,5 | 2.6 Scores on a scale | Standard Deviation 28.74 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 97, n=4,5,3 | 16.7 Scores on a scale | Standard Deviation 20.41 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 115,n=2,6,3 | -5.6 Scores on a scale | Standard Deviation 17.21 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 43,n=15,14,4 | 14.3 Scores on a scale | Standard Deviation 28.39 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 07,n=48,47,17 | -2.1 Scores on a scale | Standard Deviation 17.59 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 25,n=20,23,7 | -1.4 Scores on a scale | Standard Deviation 24.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 61,n=11,11,3 | 15.2 Scores on a scale | Standard Deviation 31.14 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 43,n=15,14,4 | 1.2 Scores on a scale | Standard Deviation 7.91 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 13,n=29,29,16 | -5.7 Scores on a scale | Standard Deviation 17.97 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 115, n=2,6,3 | 2.8 Scores on a scale | Standard Deviation 24.53 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 169,n=0,1,0 | 33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 97,n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 37,n=15,13, 5 | 15.4 Scores on a scale | Standard Deviation 25.15 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 07,n=48,47,17 | 1.4 Scores on a scale | Standard Deviation 27.1 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 19,n=19,27,10 | 1.2 Scores on a scale | Standard Deviation 17.25 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 25,n=20,23,7 | 0.0 Scores on a scale | Standard Deviation 32.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 133,n=2,1,2 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 133, n=2,1,2 | 33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 151,n=0,2,0 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 169,n=0,1,0 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 61, n=11,11,3 | 4.5 Scores on a scale | Standard Deviation 7.78 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 186,n=41,46,17 | -5.1 Scores on a scale | Standard Deviation 28.08 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 25,n=20,23,7 | -1.4 Scores on a scale | Standard Deviation 18.74 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 07,n=48,47,17 | 2.8 Scores on a scale | Standard Deviation 24.9 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 19,n=19,27,10 | -0.6 Scores on a scale | Standard Deviation 22.87 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 31,n=15,18,7 | -0.9 Scores on a scale | Standard Deviation 23.9 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 13,n=29,29,16 | 4.6 Scores on a scale | Standard Deviation 19.36 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 43,n=15,14,4 | 10.7 Scores on a scale | Standard Deviation 15.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 31,n=15,18,7 | -3.7 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 79, n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 97,n=4,5,3 | 13.3 Scores on a scale | Standard Deviation 18.26 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 133,n=2,1,2 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 25, n=20, 23, 7 | 1.4 Scores on a scale | Standard Deviation 21.27 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 19,n=19,27,10 | 3.7 Scores on a scale | Standard Deviation 26.69 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 37,n=15,13,5 | -5.1 Scores on a scale | Standard Deviation 22.96 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 25,n=20,23,7 | -1.4 Scores on a scale | Standard Deviation 15.82 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 31,n=15,18,7 | 3.7 Scores on a scale | Standard Deviation 34.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 31,n=15,18,7 | 5.1 Scores on a scale | Standard Deviation 20.44 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 31,n=15,18, 7 | -1.9 Scores on a scale | Standard Deviation 17.98 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 43,n=15,14,4 | -2.4 Scores on a scale | Standard Deviation 20.52 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 115,n=2,6,3 | 1.4 Scores on a scale | Standard Deviation 22 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 37,n=15,13,5 | -2.6 Scores on a scale | Standard Deviation 16.45 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 31, n=15,18, 7 | -3.7 Scores on a scale | Standard Deviation 19.43 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 97, n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 43,n=15,14,4 | 0.0 Scores on a scale | Standard Deviation 22.65 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 43,n=15,14, 4 | 14.8 Scores on a scale | Standard Deviation 26.04 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 61,n=11,11,3 | -9.1 Scores on a scale | Standard Deviation 30.15 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 61,n=11,11,3 | 6.1 Scores on a scale | Standard Deviation 29.13 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 07,n=48,47,17 | -1.0 Scores on a scale | Standard Deviation 21.93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 37,n=15,13,5 | -10.3 Scores on a scale | Standard Deviation 24.09 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 79,n=3,2,1 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 37, n=15,13, 5 | 3.8 Scores on a scale | Standard Deviation 13.87 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 97,n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 37,n=15,13,5 | 3.8 Scores on a scale | Standard Deviation 39.76 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 115, n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 115,n=2,6,3 | 22.2 Scores on a scale | Standard Deviation 50.18 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 97,n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 07,n=48,47,17 | -4.1 Scores on a scale | Standard Deviation 18.54 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 133,n=2,1,2 | -33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 43, n=15,14, 4 | 1.2 Scores on a scale | Standard Deviation 10.26 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 151,n=0,2,0 | -33.3 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 169,n=0,1,0 | -33.3 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 151,n=0,2,0 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 186,n=41,46,17 | 12.3 Scores on a scale | Standard Deviation 25.68 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 115,n=2,6,3 | -5.6 Scores on a scale | Standard Deviation 13.61 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 186,n=41,46,17 | 5.9 Scores on a scale | Standard Deviation 21.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 07,n=48,47,17 | 1.5 Scores on a scale | Standard Deviation 23.8 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 19,n=19,27,10 | 0 Scores on a scale | Standard Deviation 12.42 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 25,n=20,23,7 | 7.1 Scores on a scale | Standard Deviation 8.91 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 19,n=19,27,10 | 10.0 Scores on a scale | Standard Deviation 22.5 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 13,n=29,29,16 | -7.3 Scores on a scale | Standard Deviation 31.01 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 13,n=29,29,16 | 1.0 Scores on a scale | Standard Deviation 14.23 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 31,n=15,18,7 | 2.4 Scores on a scale | Standard Deviation 14.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 37,n=15,13,5 | 11.7 Scores on a scale | Standard Deviation 4.56 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 43,n=15,14,4 | 12.5 Scores on a scale | Standard Deviation 10.76 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 79,n=3,2,1 | 16.7 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 97,n=4,5,3 | 8.3 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 115,n=2,6,3 | 2.8 Scores on a scale | Standard Deviation 4.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 133,n=2,1,2 | -8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | GHS/QoL,Week 186n=41,46,17 | -3.9 Scores on a scale | Standard Deviation 15.34 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 07,n=48,47,17 | -5.5 Scores on a scale | Standard Deviation 24.18 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 13, n=29,29,16 | -12.5 Scores on a scale | Standard Deviation 23.84 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,,Week 19,n=19,27,10 | -4.0 Scores on a scale | Standard Deviation 14.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 25, n=20,23,7 | -1.0 Scores on a scale | Standard Deviation 14.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF,Week 31,n=15,18,7 | 4.8 Scores on a scale | Standard Deviation 10.69 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 37,n=15,13, 5 | 10.7 Scores on a scale | Standard Deviation 18.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 43,n=15,14, 4 | 6.7 Scores on a scale | Standard Deviation 27.22 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 61,n=11,11, 3 | 15.6 Scores on a scale | Standard Deviation 3.85 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 79,n=3,2, 2 | 10.0 Scores on a scale | Standard Deviation 4.71 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 97,n=4,5, 3 | -2.2 Scores on a scale | Standard Deviation 23.41 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 115,n=2,6, 3 | 4.4 Scores on a scale | Standard Deviation 10.18 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 133,n=2,1, 2 | -6.7 Scores on a scale | Standard Deviation 18.86 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | PF, Week 186,n=41,46,17 | -13.3 Scores on a scale | Standard Deviation 24.38 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 07,n=48,47,17 | -7.8 Scores on a scale | Standard Deviation 25.08 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 13,n=29,29,16 | -6.3 Scores on a scale | Standard Deviation 30.96 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 19,n=19,27,10 | -5.0 Scores on a scale | Standard Deviation 23.64 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 25,n=20,23,7 | 11.9 Scores on a scale | Standard Deviation 32.93 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 31,n=15,18,7 | 7.1 Scores on a scale | Standard Deviation 21.21 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 37,n=15,13,5 | 20.0 Scores on a scale | Standard Deviation 27.39 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 43,n=15,14,4 | 8.3 Scores on a scale | Standard Deviation 21.52 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 61,n=11,11,3 | 16.7 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 79,n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 97,n=4,5,3 | 5.6 Scores on a scale | Standard Deviation 34.69 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 115,n=2,6,3 | 16.7 Scores on a scale | Standard Deviation 44.1 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 133,n=2,1,2 | 25.0 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | RF,Week 186,n=41,46,17 | -16.7 Scores on a scale | Standard Deviation 30.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 07,n=48,47,17 | -4.4 Scores on a scale | Standard Deviation 21.27 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 13,n=29,29,16 | -9.4 Scores on a scale | Standard Deviation 23.35 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 19,n=19,27,10 | -1.7 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 25, n=20, 23, 7 | -2.4 Scores on a scale | Standard Deviation 14.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 31, n=15,18, 7 | 1.2 Scores on a scale | Standard Deviation 18.28 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 37, n=15,13, 5 | 13.3 Scores on a scale | Standard Deviation 16.24 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 43, n=15,14, 4 | 4.2 Scores on a scale | Standard Deviation 4.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 61, n=11,11, 3 | 19.4 Scores on a scale | Standard Deviation 12.73 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 79, n=3,2,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 97, n=4,5,3 | 8.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 115, n=2,6,3 | 11.1 Scores on a scale | Standard Deviation 12.73 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 133, n=2,1,2 | 8.3 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | EF,Week 186, n=41,46,17 | -10.8 Scores on a scale | Standard Deviation 17.37 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 07,n=48,47,17 | -1.0 Scores on a scale | Standard Deviation 20.81 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 79, n=3,2,2 | 25.0 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 13,n=29,29,16 | -15.6 Scores on a scale | Standard Deviation 27.53 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 97, n=4,5,3 | 33.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 115, n=2,6,3 | 27.8 Scores on a scale | Standard Deviation 25.46 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 19,n=19,27,10 | -6.7 Scores on a scale | Standard Deviation 21.08 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 25, n=20, 23, 7 | -11.9 Scores on a scale | Standard Deviation 18.54 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 31, n=15,18, 7 | -4.8 Scores on a scale | Standard Deviation 12.6 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 37, n=15,13, 5 | 3.3 Scores on a scale | Standard Deviation 13.94 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 43, n=15,14, 4 | -4.2 Scores on a scale | Standard Deviation 8.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 61, n=11,11, 3 | 5.6 Scores on a scale | Standard Deviation 9.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 79, n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 133, n=2,1,2 | 41.7 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 97, n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 115, n=2,6,3 | 11.1 Scores on a scale | Standard Deviation 9.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 186, n=41,46,17 | -8.8 Scores on a scale | Standard Deviation 31.8 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 07,n=48,47,17 | -5.2 Scores on a scale | Standard Deviation 20.83 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 133, n=2,1,2 | 8.3 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 13,n=29,29,16 | -1.4 Scores on a scale | Standard Deviation 24.97 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | CF,Week 186, n=41,46,17 | -9.8 Scores on a scale | Standard Deviation 13.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 19,n=19,27,10 | -11.1 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 25, n=20, 23, 7 | -11.1 Scores on a scale | Standard Deviation 16.97 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 07,n=48,47,17 | -1.0 Scores on a scale | Standard Deviation 33.58 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 19,n=19,27,10 | -6.7 Scores on a scale | Standard Deviation 28.54 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 25, n=20, 23, 7 | 2.4 Scores on a scale | Standard Deviation 32.53 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 115,n=2,6,3 | 0.0 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 31, n=15,18, 7 | -12.7 Scores on a scale | Standard Deviation 18.62 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 133,n=2,1,2 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 31, n=15,18, 7 | 2.4 Scores on a scale | Standard Deviation 24.4 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 37, n=15,13, 5 | 20.0 Scores on a scale | Standard Deviation 21.73 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 43, n=15,14, 4 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | SF,Week 61, n=11,11, 3 | 33.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 37, n=15,13, 5 | -20.0 Scores on a scale | Standard Deviation 14.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 43, n=15,14, 4 | -22.2 Scores on a scale | Standard Deviation 12.83 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 61, n=11,11, 3 | -11.1 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 79, n=3,2,2 | 5.6 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 186,n=41,46,17 | 2.0 Scores on a scale | Standard Deviation 21.96 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 07,n=48,47,17 | -7.8 Scores on a scale | Standard Deviation 25.08 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 13,n=29,29,16 | 8.3 Scores on a scale | Standard Deviation 31.03 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 19,n=19,27,10 | -3.3 Scores on a scale | Standard Deviation 18.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 25,n=20,23,7 | -14.3 Scores on a scale | Standard Deviation 32.53 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 31,n=15,18,7 | -19.0 Scores on a scale | Standard Deviation 26.23 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 37,n=15,13,5 | -20.0 Scores on a scale | Standard Deviation 38.01 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 43,n=15,14,4 | -16.7 Scores on a scale | Standard Deviation 43.03 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 61,n=11,11,3 | -11.1 Scores on a scale | Standard Deviation 38.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 97,n=4,5,3 | -22.2 Scores on a scale | Standard Deviation 50.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 115,n=2,6,3 | -22.2 Scores on a scale | Standard Deviation 50.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 133,n=2,1,2 | -50.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Constipation,Week 186,n=41,46,17 | 3.9 Scores on a scale | Standard Deviation 33.09 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 07,n=48,47,17 | -2.0 Scores on a scale | Standard Deviation 24.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 97, n=4,5,3 | -25.9 Scores on a scale | Standard Deviation 23.13 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 115, n=2,6,3 | -18.5 Scores on a scale | Standard Deviation 23.13 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 133, n=2,1,2 | -22.2 Scores on a scale | Standard Deviation 15.71 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Fatigue,Week 186, n=41,46,17 | 6.5 Scores on a scale | Standard Deviation 22.93 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 07,n=48,47,17 | 2.0 Scores on a scale | Standard Deviation 14.29 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 13,n=29,29,16 | 7.3 Scores on a scale | Standard Deviation 25.8 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 19,n=19,27,10 | 1.7 Scores on a scale | Standard Deviation 5.27 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 25,n=20,23,7 | -4.8 Scores on a scale | Standard Deviation 12.6 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 31,n=15,18,7 | -2.4 Scores on a scale | Standard Deviation 15 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 37,n=15,13, 5 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 43,n=15,14,4 | -8.3 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 61, n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 79, n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 97, n=4,5,3 | -11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 115, n=2,6,3 | -16.7 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V,Week 133, n=2,1,2 | -25.0 Scores on a scale | Standard Deviation 11.79 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | N/V, Week 186, n=41,46,17 | 1.0 Scores on a scale | Standard Deviation 21.63 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 07,n=48,47,17 | 8.8 Scores on a scale | Standard Deviation 28.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 13,n=29,28,16 | 5.2 Scores on a scale | Standard Deviation 27.02 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 19,n=19,27,10 | 1.7 Scores on a scale | Standard Deviation 30.88 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 25,n=20,23,7 | -0.0 Scores on a scale | Standard Deviation 28.87 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 31,n=15,18,7 | 2.4 Scores on a scale | Standard Deviation 35.26 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 37,n=15,13,5 | -3.3 Scores on a scale | Standard Deviation 24.72 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 43,n=15,14,4 | 4.2 Scores on a scale | Standard Deviation 36.96 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 61,n=11,11,3 | -5.6 Scores on a scale | Standard Deviation 34.69 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 79,n=3,2,2 | 8.3 Scores on a scale | Standard Deviation 58.93 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 97,n=4,5,3 | -0.0 Scores on a scale | Standard Deviation 44.1 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 115,n=2,6, 3 | 5.6 Scores on a scale | Standard Deviation 53.58 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 133,n=2,1, 2 | 16.7 Scores on a scale | Standard Deviation 70.71 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Pain,Week 186,n=41,46, 17 | 16.7 Scores on a scale | Standard Deviation 31.73 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 07,n=48,47,17 | -7.8 Scores on a scale | Standard Deviation 18.74 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 13,n=29,29,16 | 2.1 Scores on a scale | Standard Deviation 30.96 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 19,n=19,27,10 | -16.7 Scores on a scale | Standard Deviation 28.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 25,n=20,23,7 | 0.0 Scores on a scale | Standard Deviation 27.22 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 31,n=15, 18, 7 | -9.5 Scores on a scale | Standard Deviation 16.27 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 37,n=15, 13, 5 | -26.7 Scores on a scale | Standard Deviation 27.89 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 43,n=15, 14, 4 | -25.0 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 61,n=11,11,3 | -33.3 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 79,n=3, 2,2 | -33.3 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 97,n=4, 5,3 | -22.2 Scores on a scale | Standard Deviation 38.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 115,n=2, 6,3 | -33.3 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 133,n=2,1,2 | -16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Dyspnoea,Week 186,n=41, 46,17 | -9.8 Scores on a scale | Standard Deviation 25.72 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 07,n=48, 47, 17 | -0.0 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 13,n=29,29,16 | -0.0 Scores on a scale | Standard Deviation 34.43 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 19,n=19,27,10 | -13.3 Scores on a scale | Standard Deviation 35.83 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 25,n=20,23,7 | 0.0 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 31,n=15,18,7 | 4.8 Scores on a scale | Standard Deviation 40.5 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 37,n=15,13,5 | -13.3 Scores on a scale | Standard Deviation 38.01 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 43,n=15,14,4 | -0.0 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 61,n=11,11,3 | -11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 79,n=3,2,2 | -33.3 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 97,n=4,5,3 | -44.4 Scores on a scale | Standard Deviation 38.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 115,n=2,6,3 | -33.3 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 133,n=2,1,2 | -66.7 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Insomnia,Week 186,n=41,46,17 | 2.0 Scores on a scale | Standard Deviation 29.98 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 07,n=48,47,17 | 2.0 Scores on a scale | Standard Deviation 27.56 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 13,n=29,29,16 | 12.5 Scores on a scale | Standard Deviation 26.87 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 19,n=19,27,10 | -3.3 Scores on a scale | Standard Deviation 10.54 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 25,n=20, 23, 7 | -9.5 Scores on a scale | Standard Deviation 16.27 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 31,n=15,18, 7 | -4.8 Scores on a scale | Standard Deviation 23 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 13,n=29,29,16 | 4.2 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 37,n=15,13,5 | -20.0 Scores on a scale | Standard Deviation 18.26 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 43,n=15,14,4 | -25.0 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 61,n=11,11,3 | 11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 19,n=19,27,10 | -3.3 Scores on a scale | Standard Deviation 18.92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 25,n=20,23,7 | -19.0 Scores on a scale | Standard Deviation 17.82 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 31,n=15,18,7 | -4.8 Scores on a scale | Standard Deviation 29.99 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 37,n=15,13,5 | -20.0 Scores on a scale | Standard Deviation 18.26 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 43,n=15,14,4 | -16.7 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 61,n=11,11,3 | 0.0 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 79,n=3,2,2 | 0.0 Scores on a scale | Standard Deviation 47.14 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 97,n=4,5,3 | -22.2 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 115,n=2,6,3 | -22.2 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 133,n=2,1,2 | -33.3 Scores on a scale | Standard Deviation 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | Diarrhoea,Week 186,n=41,46,17 | 0.0 Scores on a scale | Standard Deviation 35.36 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 07,n=48,47,17 | 0.0 Scores on a scale | Standard Deviation 16.67 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 79,n=3,2,2 | 16.7 Scores on a scale | Standard Deviation 23.57 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | AL,Week 97,n=4,5,3 | 0.0 Scores on a scale | Standard Deviation 33.33 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 13,n=29,29,16 | 10.4 Scores on a scale | Standard Deviation 20.07 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 25,n=20,23,7 | 0.0 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 31,n=15,18, 7 | 4.8 Scores on a scale | Standard Deviation 23 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 37,n=15,13,5 | 6.7 Scores on a scale | Standard Deviation 14.91 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 43,n=15,14,4 | 8.3 Scores on a scale | Standard Deviation 31.91 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 61,n=11,11,3 | 11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 79,n=3,2,1 | 0.0 Scores on a scale | — |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 97,n=4,5,3 | -11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 115,n=2,6,3 | -11.1 Scores on a scale | Standard Deviation 19.25 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score | FD,Week 133,n=2,1,2 | -16.7 Scores on a scale | Standard Deviation 23.57 |
Secondary
Clinical Benefit Rate by Independent Review Committee (Efficacy Population)
CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Independent Review Committee (Efficacy Population) | 34 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Independent Review Committee (Efficacy Population) | 38 Percentage of Participants |
Secondary
Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)
CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Independent Review Committee (Full Analysis Population) | 36 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Independent Review Committee (Full Analysis Population) | 40 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Clinical Benefit Rate by Independent Review Committee (Full Analysis Population) | 56 Percentage of Participants |
Secondary
Clinical Benefit Rate by Investigator Assessment (Efficacy Population)
CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Investigator Assessment (Efficacy Population) | 34 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Clinical Benefit Rate by Investigator Assessment (Efficacy Population) | 35 Percentage of Participants |
Secondary
Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population) | 35 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population) | 38 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population) | 60 Percentage of Participants |
Secondary
Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 0.903 Nanogram per milliliter | Geometric Coefficient of Variation 63.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 0.660 Nanogram per milliliter | Geometric Coefficient of Variation 52.3 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 1.148 Nanogram per milliliter | Geometric Coefficient of Variation 64.7 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 0.749 Nanogram per milliliter | Geometric Coefficient of Variation 66.2 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 1.017 Nanogram per milliliter | Geometric Coefficient of Variation 61.4 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 0.656 Nanogram per milliliter | Geometric Coefficient of Variation 47.6 |
Secondary
Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 49.34 Microgram per milliliter | Geometric Coefficient of Variation 32.9 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 48.94 Microgram per milliliter | Geometric Coefficient of Variation 30 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 55.60 Microgram per milliliter | Geometric Coefficient of Variation 26.5 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 61.06 Microgram per milliliter | Geometric Coefficient of Variation 26.9 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 60.08 Microgram per milliliter | Geometric Coefficient of Variation 18.3 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 65.07 Microgram per milliliter | Geometric Coefficient of Variation 17.4 |
Secondary
Duration of Response by Independent Review Committee (Efficacy Population)
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Duration of Response by Independent Review Committee (Efficacy Population) | 11.0 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Duration of Response by Independent Review Committee (Efficacy Population) | 15.9 Months |
Secondary
Duration of Response by Independent Review Committee (Full Analysis Population)
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Duration of Response by Independent Review Committee (Full Analysis Population) | 12.5 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Duration of Response by Independent Review Committee (Full Analysis Population) | 6.2 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Duration of Response by Independent Review Committee (Full Analysis Population) | 9.0 Months |
Secondary
Duration of Response by Investigator Assessment (Efficacy Population)
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Duration of Response by Investigator Assessment (Efficacy Population) | 6.9 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Duration of Response by Investigator Assessment (Efficacy Population) | 15.9 Months |
Secondary
Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Duration of Response (DoR) by Investigator Assessment (Full Analysis Population) | 12.4 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Duration of Response (DoR) by Investigator Assessment (Full Analysis Population) | 12.6 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Duration of Response (DoR) by Investigator Assessment (Full Analysis Population) | 5.3 Months |
Secondary
Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 42.51 Microgram per milliliter | Geometric Coefficient of Variation 26.3 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 42.35 Microgram per milliliter | Geometric Coefficient of Variation 25.6 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 52.03 Microgram per milliliter | Geometric Coefficient of Variation 19.8 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 45.5 Microgram per milliliter | Geometric Coefficient of Variation 25.3 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 51.32 Microgram per milliliter | Geometric Coefficient of Variation 18.3 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 48.06 Microgram per milliliter | Geometric Coefficient of Variation 17.1 |
Secondary
Number of Participants With Abnormal Findings During Physical Examination
Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.
Time frame: Up to 186 weeks
Population: Full Safety Population. This analysis was planned, but data was not collected and captured in the database.
Secondary
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result
Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Time frame: Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result | 0 Participants |
Secondary
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline \<0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from Baseline \>=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, possible worsened vision, n=88,94,24 | 11 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, possible worsened vision, n=87,93,23 | 21 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, no change/improved vision, n=87,93,23 | 32 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, no change/improved vision, n=88,94,24 | 35 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, definite worsened vision, n=87,93,23 | 34 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, definite worsened vision, n=88,94,24 | 42 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, no change/improved vision, n=87,93,23 | 38 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, possible worsened vision, n=88,94,24 | 15 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, definite worsened vision, n=88,94,24 | 34 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, no change/improved vision, n=88,94,24 | 45 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, possible worsened vision, n=87,93,23 | 13 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, definite worsened vision, n=87,93,23 | 42 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, definite worsened vision, n=87,93,23 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, possible worsened vision, n=87,93,23 | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, possible worsened vision, n=88,94,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, no change/improved vision, n=88,94,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Right eye, no change/improved vision, n=87,93,23 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores | Left eye, definite worsened vision, n=88,94,24 | 16 Participants |
Secondary
Number of Participants With Change From Baseline in Body Temperature
Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to \<=35 degrees celsius', 'increase to \>=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to \>=38 to increase to \>=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<=35' and 'increased to \>=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Change to normal or no change | 86 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Decrease to <=35 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Increase to >=38 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Change to normal or no change | 85 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Decrease to <=35 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Body Temperature | Increase to >=38 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Body Temperature | Change to normal or no change | 21 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Body Temperature | Increase to >=38 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Body Temperature | Decrease to <=35 | 0 Participants |
Secondary
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range
Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein,Urea enzymatic colorimetry.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, decrease to low, n=90,93,24 | 12 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, increase to high, n=95,98,24 | 29 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, decrease to low, n=95,98,24 | 26 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, increase to high, n=90,93,24 | 12 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, change to normal or NC, n=94,98,24 | 49 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, increase to high, n=70,72,21 | 10 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, decrease to low, n=70,72,21 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, change to normal or NC, n=95,98,24 | 49 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, decrease to low, n=94,97,24 | 17 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, decrease to low, n=92,98,23 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, decrease to low, n=94,98,24 | 32 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, increase to high, n=92,98,23 | 45 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, increase to high, n=94,98,24 | 17 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry , decrease to low, n=90,93,24 | 10 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, increase to high, n=90,93,24 | 15 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, change to normal or NC, n=92,98,23 | 46 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, change to normal or NC, n=70,72,21 | 60 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, change to normal or NC, n=90,93,24 | 66 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, change to normal or NC, n=90,93,24 | 67 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, increase to high, n=94,97,24 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, change to normal or NC, n=94,97,24 | 63 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, increase to high, n=94,98,24 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, change to normal or NC, n=90,93,24 | 59 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, increase to high, n=70,72,21 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, decrease to low, n=90,93,24 | 22 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry , decrease to low, n=90,93,24 | 13 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, change to normal or NC, n=90,93,24 | 56 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, increase to high, n=90,93,24 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, decrease to low, n=70,72,21 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, change to normal or NC, n=70,72,21 | 60 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, decrease to low, n=95,98,24 | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, change to normal or NC, n=95,98,24 | 48 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, increase to high, n=95,98,24 | 27 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, decrease to low, n=94,97,24 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, change to normal or NC, n=94,97,24 | 63 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, increase to high, n=94,97,24 | 24 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, decrease to low, n=92,98,23 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, change to normal or NC, n=92,98,23 | 51 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, increase to high, n=92,98,23 | 47 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, decrease to low, n=94,98,24 | 32 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, change to normal or NC, n=94,98,24 | 58 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, increase to high, n=90,93,24 | 26 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, increase to high, n=90,93,24 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, increase to high, n=92,98,23 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, change to normal or NC, n=94,97,24 | 20 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry, change to normal or NC, n=90,93,24 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, decrease to low, n=94,98,24 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, increase to high, n=94,97,24 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, decrease to low, n=70,72,21 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, decrease to low, n=92,98,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, increase to high, n=94,98,24 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, change to normal or NC, n=70,72,21 | 20 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, increase to high, n=90,93,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Direct Bilirubin, increase to high, n=70,72,21 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, change to normal or NC, n=90,93,24 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, decrease to low, n=95,98,24 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | LDH, change to normal or NC, n=92,98,23 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, change to normal or NC, n=95,98,24 | 9 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Bicarbonate, decrease to low, n=90,93,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Protein, change to normal or NC, n=94,98,24 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Calcium, increase to high, n=95,98,24 | 9 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Urea enzymatic colorimetry , decrease to low, n=90,93,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range | Chloride, decrease to low, n=94,97,24 | 2 Participants |
Secondary
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Following parameters were assessed:basophils,eosinophils,hematocrit,mean corpuscular hemoglobin (MCH),MCH concentration,MC volume,monocyte,erythrocytes, reticulocytes.Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range\[LNR\]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, decrease to low, n=94,96,23 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, increase to high, n=95,97,23 | 10 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, decrease to low, n=95,97,24 | 10 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, increase to high, n=95,95,21 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, decrease to low, n=95,97,24 | 6 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, increase to high, n=95,97,24 | 28 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, change to normal or NC, n=94,96,23 | 87 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, increase to high, n=94,96,23 | 5 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, decrease to low, n=95,97,23 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, change to normal or NC, n=95,97,23 | 71 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, change to normal or NC, n=95,97,24 | 84 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, increase to high, n=95,97,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21 | 79 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, decrease to low, n=94,96,21 | 20 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, change to normal or NC, n=94,96,21 | 70 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, increase to high, n=94,96,21 | 5 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, decrease to low, n=95,97,24 | 12 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, change to normal or NC, n=95,97,24 | 77 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, increase to high, n=95,97,24 | 7 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, change to normal or NC, n=95,97,24 | 62 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, decrease to low, n=95,97,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, change to normal or NC, n=95,97,24 | 91 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, increase to high, n=95,97,24 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, decrease to low, n=73,65,19 | 11 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, change to normal or NC, n=73,65,19 | 49 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, increase to high, n=73,65,19 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, increase to high, n=95,95,21 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, change to normal or NC, n=95,97,24 | 94 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, increase to high, n=95,97,24 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, decrease to low, n=95,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, change to normal or NC, n=95,97,24 | 95 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, decrease to low, n=94,96,21 | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, increase to high, n=95,97,23 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, increase to high, n=95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, decrease to low, n=95,97,24 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, change to normal or NC, n=94,96,21 | 66 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21 | 17 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, decrease to low, n=73,65,19 | 15 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, increase to high, n=95,97,24 | 45 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, change to normal or NC, n=73,65,19 | 33 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, decrease to low, n=94,96,23 | 7 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, increase to high, n=94,96,21 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, change to normal or NC, n=95,97,24 | 50 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, change to normal or NC, n=94,96,23 | 85 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, decrease to low, n=95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, increase to high, n=95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, increase to high, n=94,96,23 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, decrease to low, n=95,97,24 | 15 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, increase to high, n=73,65,19 | 21 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, decrease to low, n=95,97,23 | 13 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21 | 68 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, change to normal or NC, n=95,97,24 | 73 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, change to normal or NC, n=95,97,23 | 78 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, increase to high, n=95,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, increase to high, n=95,97,23 | 7 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, decrease to low, n=95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, decrease to low, n=95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, increase to high, n=95,95,21 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, decrease to low, n=94,96,21 | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, change to normal or NC, n=95,97,24 | 21 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, change to normal or NC, n=94,96,21 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | MCH Concentration, increase to high, n=94,96,21 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, decrease to low, n=95,97,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythrocytes, increase to high, n=95,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Volume, change to normal or NC, n=95,97,24 | 18 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, change to normal or NC, n=73,65,19 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, change to normal or NC, n=95,97,24 | 23 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hematocrit, increase to high, n=95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, change to normal or NC, n=95,97,23 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, decrease to low, n=95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, increase to high, n=73,65,19 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, decrease to low, n=94,96,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, change to normal or NC, n=94,96,23 | 19 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, change to normal or NC, n=95,97,24 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Basophils, increase to high, n=94,96,23 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Monocytes, increase to high, n=95,97,24 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosinophils, decrease to low, n=95,97,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Reticulocytes, decrease to low, n=73,65,19 | 7 Participants |
Secondary
Number of Participants With Change From Baseline in Pulse Rate
Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to \<60 beats per minute \[bpm\]', 'increase to \>100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to \>100 bpm to increase to \>100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<60 bpm' and 'increased to \>100 bpm' during post Baseline. Data for worst-case post Baseline is presented.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Change to normal or no change | 57 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Decrease to <60 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Increase to >100 | 25 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Change to normal or no change | 55 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Decrease to <60 | 17 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Change From Baseline in Pulse Rate | Increase to >100 | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Pulse Rate | Decrease to <60 | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Pulse Rate | Increase to >100 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Change From Baseline in Pulse Rate | Change to normal or no change | 15 Participants |
Secondary
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for analysis of:glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil),creatinine kinase (CK),creatinine, gamma glutamyl transferase (GGT),potassium (Pot), magnesium (Mg),sodium (Sod), phosphate (Ph) urate & estimated glomerular filtration rate (eGFR). Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Grading was according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented.Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 3, n=94,95,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 3, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 3, n=94,98,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 4, n=94,98,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 3, n=93,97,24 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 4, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 3, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 4, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 3, n=93,96,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 3, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 4, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 4, n= 87,91,24 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 3, n= 95,97,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 4, n= 91,95,24 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 4, n= 95,97,24 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 3, n= 91,96,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 3, n= 95,97,24 | 2 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 3, n= 93,96,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 4, n= 93,96,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 3, n= 84,85,23 | 8 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 4, n= 84,85,23 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 4, n=93,96,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 3, n= 87,91,24 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 4, n= 95,97,24 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 3, n= 91,95,24 | 5 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 3, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 3, n= 90,93,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 4, n= 90,93,24 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 4, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 4, n=94,98,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 4, n= 87,91,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 3, n= 95,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 3, n= 91,95,24 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 3, n= 95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 3, n= 91,96,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 3, n= 84,85,23 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 3, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 4, n= 91,95,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 3, n= 90,93,24 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 4, n= 90,93,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 3, n= 95,97,24 | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 3, n= 95,97,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 3, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 3, n= 93,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 3, n=94,98,24 | 7 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 4, n= 93,96,24 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 3, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 3, n= 87,91,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 3, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 4, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 4, n= 84,85,23 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 3, n=93,96,24 | 7 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 4, n=93,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 3, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 3, n=94,95,24 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 4, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 3, n= 87,91,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 3, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | CK, increase to Grade 4, n= 87,91,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 4, n=94,98,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 3, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hyper, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 3, n= 91,95,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 3, n= 95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | GGT, increase to Grade 4, n= 91,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 3, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 3, n= 84,85,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 3, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 3, n= 90,93,24 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 4, n=93,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Gl, Hypo, increase to Grade 4, n=94,95,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hyper, increase to Grade 3, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 3, n= 93,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALT, increase to Grade 4, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, increase to Grade 3, n=94,98,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 3, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hypo, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Mg, Hypo, increase to Grade 4, n= 91,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | eGFR, increase to Grade 4, n= 84,85,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | T.Bil, increase to Grade 4, n=92,97,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, increase to Grade 4, n= 90,93,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 3, n=93,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Urate, increase to Grade 4, n= 93,96,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hyper, increase to Grade 4, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Pot, Hyper,increase to Grade 3, n= 95,97,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | AST, increase to Grade 3, n=93,96,24 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Sod, Hypo, increase to Grade 3, n= 95,97,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | ALP, increase to Grade 4, n=93,97,24 | 0 Participants |
Secondary
Number of Participants With Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 4 | 5 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 3 | 19 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 3 | 16 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 4 | 13 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 3 | 5 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 3 | 9 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 4 | 6 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 4 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 3 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 4 | 25 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 4 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 3 | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 4 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 3 | 30 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 3 | 24 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 4 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 3 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 3 | 9 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 3 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Neutro, increase to Grade 4 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leuko decreased, increase to Grade 3 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 3 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 3 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Leuko, Leukocytosis, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 4 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count increased, increase to Grade 4 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Anemia, increase to Grade 3 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | PC, increase to Grade 4 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Lymph, Lymph count decreased, increase to Grade 3 | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Hematology Parameters | Hb, Hb increased, increase to Grade 4 | 0 Participants |
Secondary
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: \<120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: \>=160 mmHg. For DBP: Grade 0: \<80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: \>=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented.
Time frame: Baseline (Day 1) and Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 3 | 9 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 3 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 2 | 18 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 2 | 29 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 3 | 22 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 2 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 2 | 41 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 3 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 2 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 3 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, increase to Grade 3 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, increase to Grade 2 | 4 Participants |
Secondary
Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP \>=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Up to 186 weeks
Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Right eye, n=88,93,23 | 17 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Left eye, n=88,92,24 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Left eye, n=88,92,24 | 15 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Right eye, n=88,93,23 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Right eye, n=88,93,23 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline | Left eye, n=88,92,24 | 7 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.
Time frame: Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Common non-SAE | 93 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | SAE | 43 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Keratopathy | 67 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Dry eye events | 17 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Infusion-related reactions | 20 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Corneal events | 68 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Neutropenia | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Blurred vision | 24 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Thrombocytopenia | 36 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Thrombocytopenia | 56 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Common non-SAE | 96 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Blurred vision | 36 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Neutropenia | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | SAE | 53 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Dry eye events | 25 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Corneal events | 76 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Keratopathy | 74 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Infusion-related reactions | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Keratopathy | 23 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Dry eye events | 6 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Blurred vision | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Thrombocytopenia | 10 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Neutropenia | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Infusion-related reactions | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Common non-SAE | 24 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | SAE | 15 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) | Corneal events | 23 Participants |
Secondary
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline and Up to 186 weeks
Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Left eye,n=95,97,23 | 18 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Left eye,n=95,99,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Right eye,n=93,97,24 | 3 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Left eye,n=94,95,24 | 4 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Right eye,n=93,99,24 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Left eye,n=93,99,23 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Right eye,n=61,60,22 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Left eye,n=63,61,20 | 1 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Right eye,n=95,99,24 | 15 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Left eye,n=95,99,23 | 16 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Right eye,n=95,98,24 | 18 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Right eye, n=94,99,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Left eye,n=93,99,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Right eye, n=94,99,24 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Left eye,n=63,61,20 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Right eye,n=95,98,24 | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Left eye,n=95,99,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Right eye,n=93,99,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Left eye,n=95,99,23 | 25 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Right eye,n=93,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Right eye,n=61,60,22 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Left eye,n=95,97,23 | 29 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Left eye,n=94,95,24 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Right eye,n=95,99,24 | 24 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Left eye,n=94,95,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Right eye,n=93,99,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal Neovascularization, Left eye,n=93,99,23 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Right eye,n=61,60,22 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Left eye,n=95,99,23 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Corneal ulcer, Left eye,n=63,61,20 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Right eye,n=95,98,24 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Epithelial Microcystic Edema, Right eye,n=95,99,24 | 9 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Right eye, n=94,99,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active edema, Left eye,n=95,99,24 | 1 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Active opacity, Right eye,n=93,97,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) | Subepithelial haze, Left eye,n=95,97,23 | 6 Participants |
Secondary
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline and Up to 186 weeks
Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Left eye,n=55,55,15 | 39 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Left eye,n=92,89,23 | 8 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Right eye, n=53,54,17 | 39 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Right eye,n=92,94,24 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Left eye,n=92,89,23 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Right eye, n=53,54,17 | 40 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Right eye,n=92,94,24 | 7 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Left eye,n=55,55,15 | 44 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Right eye, n=53,54,17 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Right eye,n=92,94,24 | 3 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CE, Left eye,n=55,55,15 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) | CS, Left eye,n=92,89,23 | 3 Participants |
Secondary
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline and Up to 186 weeks
Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Right eye,n=95,93,23 | 0 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Left eye,n=93,92,22 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Right eye,n=95,93,23 | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Left eye,n=93,92,22 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Right eye,n=95,93,23 | 0 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) | Left eye,n=93,92,22 | 0 Participants |
Secondary
Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented.
Time frame: Baseline and Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) | 4 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) | 3 Participants |
Secondary
Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from \>10 seconds (Baseline) to \<=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time frame: Baseline and Up to 186 weeks
Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Left eye,n=34,30,2 | 14 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Right eye,n=30,31,2 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Left eye,n=34,30,2 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Right eye,n=30,31,2 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Left eye,n=34,30,2 | 2 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) | Right eye,n=30,31,2 | 1 Participants |
Secondary
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.
Time frame: Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Blurred Vision, n= 84,92,22 | 59 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Chills, n=43,42,13 | 39 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Constipation, n=84,92, 22 | 42 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Decreased Appetite, n=84,92, 22 | 60 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Fatigue, n=84,92, 22 | 81 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | General Pain, n= 79, 80, 20 | 78 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Mouth/Throat Sores, n=84,92, 22 | 28 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nausea, n=48, 52, 11 | 47 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Shortness Of Breath, n=84,92, 22 | 60 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Vomiting, n=21, 28, 6 | 20 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Watery Eyes, n=84,92, 22 | 50 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Heart Palpitations, n=37, 37, 14 | 35 Participants |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nosebleed, n=23, 33, 6 | 22 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Watery Eyes, n=84,92, 22 | 59 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Blurred Vision, n= 84,92,22 | 67 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Mouth/Throat Sores, n=84,92, 22 | 25 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nosebleed, n=23, 33, 6 | 33 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Chills, n=43,42,13 | 36 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Vomiting, n=21, 28, 6 | 28 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Constipation, n=84,92, 22 | 47 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Heart Palpitations, n=37, 37, 14 | 33 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nausea, n=48, 52, 11 | 50 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Decreased Appetite, n=84,92, 22 | 65 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | General Pain, n= 79, 80, 20 | 80 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Shortness Of Breath, n=84,92, 22 | 58 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Fatigue, n=84,92, 22 | 87 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Shortness Of Breath, n=84,92, 22 | 17 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | General Pain, n= 79, 80, 20 | 19 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Heart Palpitations, n=37, 37, 14 | 14 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Mouth/Throat Sores, n=84,92, 22 | 8 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nausea, n=48, 52, 11 | 11 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Watery Eyes, n=84,92, 22 | 19 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Fatigue, n=84,92, 22 | 21 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Blurred Vision, n= 84,92,22 | 19 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Chills, n=43,42,13 | 12 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Constipation, n=84,92, 22 | 17 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Vomiting, n=21, 28, 6 | 5 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Decreased Appetite, n=84,92, 22 | 16 Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Nosebleed, n=23, 33, 6 | 6 Participants |
Secondary
Overall Response Rate by Investigator Assessment (Efficacy Population)
ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Overall Response Rate by Investigator Assessment (Efficacy Population) | 33 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Overall Response Rate by Investigator Assessment (Efficacy Population) | 26 Percentage of Participants |
Secondary
Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)
ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population) | 33 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population) | 32 Percentage of Participants |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population) | 52 Percentage of Participants |
Secondary
Overall Survival
Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Overall Survival | 15.3 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Overall Survival | 14.0 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Overall Survival | 24.5 Months |
Secondary
Progression Free Survival by Independent Review Committee
Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Progression Free Survival by Independent Review Committee | 2.8 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Progression Free Survival by Independent Review Committee | 3.9 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Progression Free Survival by Independent Review Committee | 5.7 Months |
Secondary
Progression Free Survival by Investigator Assessment
Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Progression Free Survival by Investigator Assessment | 2.2 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Progression Free Survival by Investigator Assessment | 3.2 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Progression Free Survival by Investigator Assessment | 3.6 Months |
Secondary
t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | NA Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | NA Hours |
Secondary
t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,17,19 | 241.8 Hours | Geometric Coefficient of Variation 49.3 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,23,11 | 352.4 Hours | Geometric Coefficient of Variation 52.6 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,17,19 | 250.8 Hours | Geometric Coefficient of Variation 70.3 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,23,11 | 372.0 Hours | Geometric Coefficient of Variation 49.6 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=29,17,19 | 299.8 Hours | Geometric Coefficient of Variation 61 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=23,23,11 | 557.3 Hours | Geometric Coefficient of Variation 91.7 |
Secondary
Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=29,19,22 | 164.4 Hours | Geometric Coefficient of Variation 46.2 |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,23,11 | 193.7 Hours | Geometric Coefficient of Variation 48.4 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=29,19,22 | 165.8 Hours | Geometric Coefficient of Variation 55 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,23,11 | 214.4 Hours | Geometric Coefficient of Variation 45.9 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=29,19,22 | 196.2 Hours | Geometric Coefficient of Variation 40.9 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=26,23,11 | 279.5 Hours | Geometric Coefficient of Variation 40.3 |
Secondary
Time to Progression by Independent Review Committee
Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Progression by Independent Review Committee | 2.9 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Progression by Independent Review Committee | 4.9 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Progression by Independent Review Committee | 5.7 Months |
Secondary
Time to Progression by Investigator Assessment
Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Progression by Investigator Assessment | 2.2 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Progression by Investigator Assessment | 3.9 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Progression by Investigator Assessment | 3.6 Months |
Secondary
Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 0.780 Hours |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 0.580 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 0.700 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 0.715 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 1, n=32,21,22 | 0.750 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 0.870 Hours |
Secondary
Time to Response by Independent Review Committee (Efficacy Population)
Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Response by Independent Review Committee (Efficacy Population) | 1.5 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Response by Independent Review Committee (Efficacy Population) | 1.4 Months |
Secondary
Time to Response by Independent Review Committee (Full Analysis Population)
Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Response by Independent Review Committee (Full Analysis Population) | 1.5 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Response by Independent Review Committee (Full Analysis Population) | 1.4 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Response by Independent Review Committee (Full Analysis Population) | 0.9 Months |
Secondary
Time to Response by Investigator Assessment (Efficacy Population)
Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time frame: Up to 186 weeks
Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Response by Investigator Assessment (Efficacy Population) | 1.4 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Response by Investigator Assessment (Efficacy Population) | 1.5 Months |
Secondary
Time to Response by Investigator Assessment (Full Analysis Population)
Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time frame: Up to 186 weeks
Population: Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Time to Response by Investigator Assessment (Full Analysis Population) | 1.5 Months |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Time to Response by Investigator Assessment (Full Analysis Population) | 1.5 Months |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Time to Response by Investigator Assessment (Full Analysis Population) | 0.9 Months |
Secondary
Titers of Anti-drug Antibodies Against GSK2857916
Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arm GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values was not presented for the arm.
Time frame: Up to 186 weeks
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Titers of Anti-drug Antibodies Against GSK2857916 | 125.0 Titers | Standard Deviation 50 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Titers of Anti-drug Antibodies Against GSK2857916 | 100.0 Titers | Standard Deviation 0 |
Secondary
Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 22.830 Hours |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 23.235 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 23.835 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 22.570 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 1, n=27,20,19 | 24.080 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM | Cycle 3, n=26,29,11 | 22.780 Hours |
Secondary
Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 1.750 Hours |
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 0.830 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 1.870 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 1.150 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 1, n=30,19,20 | 0.650 Hours |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM | Cycle 3, n=29,28,11 | 1.750 Hours |
Secondary
Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time frame: Baseline (Day 1) and up to Week 186
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score | -20.0 Scores on a scale | Standard Deviation 22.6 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score | -19.6 Scores on a scale | Standard Deviation 21.66 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score | -23.1 Scores on a scale | Standard Deviation 23.82 |
Secondary
Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time frame: Baseline (Day 1) and up to Week 186
Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | 26.9 Scores on a scale | Standard Deviation 29.61 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | 28.2 Scores on a scale | Standard Deviation 28.49 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | 35.0 Scores on a scale | Standard Deviation 29.02 |