Trial Outcomes & Findings for A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma (NCT NCT02639182)
NCT ID: NCT02639182
Last Updated: 2024-11-18
Results Overview
PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months)
Results posted on
2024-11-18
Participant Flow
Participants who were atleast 18 years of age with all histologies of confirmed renal cell carcinoma and evidence of progression on or after the last regimen received were enrolled.
Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1), the number of prior systemic RCC regimens (2 or \> 2) and Renal cell carcinoma (RCC), histology (clear or nonclear cell).
Participant milestones
| Measure |
AGS-16C3F
Participants received 1.8 milligram per kilogram (mg/kg) of AGS-16C3F once every three weeks by single (60-minute) intravenous (IV) infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 milligram (mg) orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
|
Overall Study
Treated
|
66
|
65
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
67
|
66
|
Reasons for withdrawal
| Measure |
AGS-16C3F
Participants received 1.8 milligram per kilogram (mg/kg) of AGS-16C3F once every three weeks by single (60-minute) intravenous (IV) infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 milligram (mg) orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Overall Study
Disease Progression
|
50
|
49
|
|
Overall Study
Adverse Event
|
7
|
5
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Withdrew Consent
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Study Closure
|
1
|
2
|
|
Overall Study
Sponsor Ended Study
|
0
|
1
|
|
Overall Study
Randomized But Did Not Receive Study Drug
|
1
|
1
|
Baseline Characteristics
A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 9.1 • n=113 Participants
|
61.1 Years
STANDARD_DEVIATION 8.9 • n=163 Participants
|
61.7 Years
STANDARD_DEVIATION 9 • n=160 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=113 Participants
|
17 Participants
n=163 Participants
|
35 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=113 Participants
|
49 Participants
n=163 Participants
|
98 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=113 Participants
|
62 Participants
n=163 Participants
|
126 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
59 Participants
n=113 Participants
|
56 Participants
n=163 Participants
|
115 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
13 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
19 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
38 Participants
n=160 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
48 Participants
n=113 Participants
|
47 Participants
n=163 Participants
|
95 Participants
n=160 Participants
|
|
Histological Type
Clear cell
|
55 Participants
n=113 Participants
|
55 Participants
n=163 Participants
|
110 Participants
n=160 Participants
|
|
Histological Type
Non-clear cell
|
12 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
23 Participants
n=160 Participants
|
|
Prognostic Risk Group
Favorable (0 risk factors)
|
5 Participants
n=113 Participants
|
10 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
|
Prognostic Risk Group
Intermediate (1-2 risk factors)
|
48 Participants
n=113 Participants
|
43 Participants
n=163 Participants
|
91 Participants
n=160 Participants
|
|
Prognostic Risk Group
Poor (>=3 risk factors)
|
14 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
27 Participants
n=160 Participants
|
|
Number of Prior Systemic Renal cell carcinoma (RCC) Treatment Regimens
2 if clear cell or 1 if non-clear cell histology
|
35 Participants
n=113 Participants
|
33 Participants
n=163 Participants
|
68 Participants
n=160 Participants
|
|
Number of Prior Systemic Renal cell carcinoma (RCC) Treatment Regimens
>2 if clear cell or >1 if non-clear cell histology
|
32 Participants
n=113 Participants
|
33 Participants
n=163 Participants
|
65 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months)Population: FAS Population
PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review
|
2.9 Months
Interval 2.0 to 4.0
|
5.7 Months
Interval 5.3 to 9.1
|
SECONDARY outcome
Timeframe: From date of randomization to the earliest of either documented disease progression or death from any cause (up to 40 months)Population: FAS Population
PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. PD was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assessments immediately prior to death or progression; or no death and no postebaseline assessments; or if initiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
PFS Per RECIST v1.1 as Assessed by Blinded Central Radiology Assessment
|
3.5 Months
Interval 2.1 to 3.8
|
4.5 Months
Interval 3.5 to 7.6
|
SECONDARY outcome
Timeframe: From date of randomization until data cutoff date of 21 August 2019 (up to 40 months)Population: FAS Population
ORR was defined as the percentage of participants who had a best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Objective Response Rate (ORR) Based on the Investigator's Radiographic Assessment
|
7.5 Percentage of Participants
Interval 2.5 to 16.6
|
18.2 Percentage of Participants
Interval 9.8 to 29.6
|
SECONDARY outcome
Timeframe: From date of first objective response until data cutoff date of 21 August 2019 (up to 40 months)Population: FAS Population
DOR was defined as the time from the date of the first response of CR or PR (whichever was first recorded) to the first date of documented PD or death due to any cause. DOR was analysed using Kaplan-Meier estimates. CR and PR were defined in outcome measure 3 and PD was defined in outcome measures 1 and 2. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Duration of Response (DOR) Based on the Investigator's Radiographic Assessment
|
6.8 Months
Interval 3.8 to 18.4
|
6.7 Months
Interval 1.8 to 9.2
|
SECONDARY outcome
Timeframe: Date of randomization until the date of death from any cause (up to 53 months)Population: FAS Population
OS was defined as the time from the date of randomization until the date of death from any cause. OS was analysed using Kaplan-Meier estimates. Participants were censored if there was no death and no postbaseline contact or no death and at least one postbaseline follow-up.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Overall Survival (OS)
|
13.1 Months
Interval 10.1 to 23.0
|
15.5 Months
Interval 12.7 to 21.6
|
SECONDARY outcome
Timeframe: Date of randomization until data cutoff date of 21 August 2019 (up to 40 months)Population: FAS Population
DCR was defined as the percentage of patients who had a best overall response of CR, PR or at least 6 months with stable disease (SD). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug.
Outcome measures
| Measure |
AGS-16C3F
n=67 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=66 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Disease Control Rate (DCR) Based on the Investigator's Radiographic Assessment
|
13.4 Percentage of Participants
Interval 6.3 to 24.0
|
22.7 Percentage of Participants
Interval 13.3 to 34.7
|
SECONDARY outcome
Timeframe: From first dose up to 53 monthsPopulation: Safety Population: All randomized participants who received at least one dose of study drug.
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. AE was considered "serious" if it results in death or is life threatening results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions or results in congenital anomaly, or birth defect requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events.
Outcome measures
| Measure |
AGS-16C3F
n=66 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=65 Participants
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
65 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: Pharmacokinetic Population (PKAS): (included all participants who were randomized to receive AGS-16C3F and had sufficient serum concentration data to facilitate derivation of at least 1 pharmacokinetic parameter, and for whom the time of dosing on the day of sampling was known) with available data at specified time point.
Cmax of ADC was reported.
Outcome measures
| Measure |
AGS-16C3F
n=59 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Antibody Drug Conjugate (ADC)
Cycle 1
|
52.21 Microgram per Milliliter (μg/mL)
Standard Deviation 58.407
|
—
|
|
Maximum Observed Serum Concentration (Cmax) of Antibody Drug Conjugate (ADC)
Cycle 4
|
48.66 Microgram per Milliliter (μg/mL)
Standard Deviation 38.820
|
—
|
SECONDARY outcome
Timeframe: Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days)Population: PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data.
Ctrough of ADC was reported.
Outcome measures
| Measure |
AGS-16C3F
n=50 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 2
|
3429.39 Nanogram per Milliliter (ng/mL)
Standard Deviation 1402.334
|
—
|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 3
|
5194.21 Nanogram per Milliliter (ng/mL)
Standard Deviation 3602.012
|
—
|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 4
|
7731.38 Nanogram per Milliliter (ng/mL)
Standard Deviation 11171.906
|
—
|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 6
|
5695.13 Nanogram per Milliliter (ng/mL)
Standard Deviation 3899.222
|
—
|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 14
|
8698.26 Nanogram per Milliliter (ng/mL)
Standard Deviation 4239.327
|
—
|
|
Mean Predose Serum Concentration (Ctrough) of ADC
Cycle 18
|
7213.32 Nanogram per Milliliter (ng/mL)
Standard Deviation 2082.501
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
Tmax of ADC was reported.
Outcome measures
| Measure |
AGS-16C3F
n=59 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax) of ADC
Cycle 1
|
0.04 Days
Interval 0.0 to 1.0
|
—
|
|
Time to Maximum Observed Serum Concentration (Tmax) of ADC
Cycle 4
|
0.05 Days
Interval 0.0 to 3.9
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
AUC (0 to 21) of ADC was reported.
Outcome measures
| Measure |
AGS-16C3F
n=52 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of ADC
Cycle 1
|
199.80 Day*Microgram per Milliliter (day*μg/mL)
Standard Deviation 68.821
|
—
|
|
Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of ADC
Cycle 4
|
293.90 Day*Microgram per Milliliter (day*μg/mL)
Standard Deviation 100.190
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
t1/2 of ADC was reported.
Outcome measures
| Measure |
AGS-16C3F
n=49 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of ADC
Cycle 1
|
6.93 Days
Interval 3.9 to 19.6
|
—
|
|
Terminal Elimination Half-life (t1/2) of ADC
Cycle 4
|
7.40 Days
Interval 3.6 to 14.5
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
Cmax of TAb was reported.
Outcome measures
| Measure |
AGS-16C3F
n=59 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Total Antibody (TAb)
Cycle 1
|
37.49 μg/mL
Standard Deviation 12.515
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (TAb)
Cycle 4
|
42.84 μg/mL
Standard Deviation 12.345
|
—
|
SECONDARY outcome
Timeframe: Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days)Population: PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data.
Ctrough of TAb was reported.
Outcome measures
| Measure |
AGS-16C3F
n=50 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 2
|
4966.69 ng/mL
Standard Deviation 2571.410
|
—
|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 3
|
6943.11 ng/mL
Standard Deviation 3666.956
|
—
|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 4
|
8660.94 ng/mL
Standard Deviation 4176.472
|
—
|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 6
|
8777.51 ng/mL
Standard Deviation 4131.388
|
—
|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 14
|
12491.90 ng/mL
Standard Deviation 6593.131
|
—
|
|
Mean Predose Serum Concnetration (Ctrough) of TAb
Cycle 18
|
11726.15 ng/mL
Standard Deviation 5572.172
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
Tmax of TAb was reported.
Outcome measures
| Measure |
AGS-16C3F
n=60 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax) of Tab
Cycle 1
|
0.05 Days
Interval 0.0 to 2.2
|
—
|
|
Time to Maximum Observed Serum Concentration (Tmax) of Tab
Cycle 4
|
0.05 Days
Interval 0.0 to 3.9
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
AUC (0 to 21) of TAb was reporetd.
Outcome measures
| Measure |
AGS-16C3F
n=48 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of TAb
Cycle 1
|
246.06 day*μg/mL
Standard Deviation 88.815
|
—
|
|
Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of TAb
Cycle 4
|
346.07 day*μg/mL
Standard Deviation 158.029
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
t1/2 of TAb was reported.
Outcome measures
| Measure |
AGS-16C3F
n=45 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Tab
Cycle 1
|
8.70 Days
Interval 4.3 to 16.6
|
—
|
|
Terminal Elimination Half-life (t1/2) of Tab
Cycle 4
|
9.15 Days
Interval 1.8 to 38.1
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
Cmax of Cys-mcMMAF was reported.
Outcome measures
| Measure |
AGS-16C3F
n=64 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Cysteine Adduct of Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF)
Cycle 1
|
6.09 ng/mL
Standard Deviation 4.08
|
—
|
|
Maximum Serum Concentration (Cmax) of Cysteine Adduct of Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF)
Cycle 4
|
3.78 ng/mL
Standard Deviation 1.70
|
—
|
SECONDARY outcome
Timeframe: Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days)Population: PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data.
Ctrough of Cys-mcMMAF was reported.
Outcome measures
| Measure |
AGS-16C3F
n=1 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Mean Predose Serum Concnetration (Ctrough) of Cys-mcMMAF
Cycle 6
|
0.307 ng/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point.
Tmax of Cys-mcMMAF was reported.
Outcome measures
| Measure |
AGS-16C3F
n=64 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax) of Cys-mcMMAF
Cycle 1
|
0.207 Days
Interval 0.139 to 0.954
|
—
|
|
Time to Maximum Observed Serum Concentration (Tmax) of Cys-mcMMAF
Cycle 4
|
0.208 Days
Interval 0.197 to 1.11
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point. Not calculated at cycle 4 due to an insufficient number of participants.
AUC (0 to 21) of Cys-mcMMAF was reporetd.
Outcome measures
| Measure |
AGS-16C3F
n=21 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of Cys-mcMMAF
Cycle 1
|
9.61 day*ng/mL
Standard Deviation 10.3
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days)Population: PKAS Population with available data at specified time point. Not calculated at cycle 4 due to an insufficient number of samples.
t1/2 of Cys-mcMMAF was reported
Outcome measures
| Measure |
AGS-16C3F
n=1 Participants
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Cys-mcMMAF
Cycle 1
|
2.72 Days
Interval 2.72 to 2.72
|
—
|
Adverse Events
AGS-16C3F
Serious events: 26 serious events
Other events: 65 other events
Deaths: 36 deaths
Axitinib
Serious events: 31 serious events
Other events: 64 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
AGS-16C3F
n=66 participants at risk
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=65 participants at risk
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Angina unstable
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Aortic valve disease
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Asthenia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Device failure
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Fatigue
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Influenza like illness
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Pyrexia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Clostridium difficile infection
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Liver function test abnormal
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Platelet count decreased
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Transaminases increased
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Altered state of consciousness
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Hemiparesis
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Spinal cord compression
|
1.5%
1/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Psychiatric disorders
Confusional state
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Surgical and medical procedures
Craniotomy
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Haematoma
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
Other adverse events
| Measure |
AGS-16C3F
n=66 participants at risk
Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
|
Axitinib
n=65 participants at risk
Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.6%
5/66 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
21.5%
14/65 • Number of events 38 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
11/66 • Number of events 12 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
4.6%
3/65 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
6/66 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.7%
15/66 • Number of events 35 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.6%
5/66 • Number of events 9 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Eye disorders
Diplopia
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Eye disorders
Dry eye
|
21.2%
14/66 • Number of events 18 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
9.2%
6/65 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Eye disorders
Eye pain
|
10.6%
7/66 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Eye disorders
Photophobia
|
7.6%
5/66 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Eye disorders
Vision blurred
|
39.4%
26/66 • Number of events 38 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
12/66 • Number of events 20 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
15.4%
10/65 • Number of events 12 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Constipation
|
24.2%
16/66 • Number of events 16 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
32.3%
21/65 • Number of events 25 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
12/66 • Number of events 18 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
47.7%
31/65 • Number of events 70 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
6/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
9.2%
6/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
4/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Nausea
|
47.0%
31/66 • Number of events 56 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
40.0%
26/65 • Number of events 40 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
23.1%
15/65 • Number of events 23 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
18/66 • Number of events 25 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
33.8%
22/65 • Number of events 38 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Asthenia
|
10.6%
7/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Chills
|
22.7%
15/66 • Number of events 29 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Fatigue
|
54.5%
36/66 • Number of events 48 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
56.9%
37/65 • Number of events 67 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Influenza like illness
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Mucosal inflammation
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 9 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Non-cardiac chest pain
|
4.5%
3/66 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Oedema peripheral
|
16.7%
11/66 • Number of events 13 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Pain
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
General disorders
Pyrexia
|
13.6%
9/66 • Number of events 18 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
4/66 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.6%
5/66 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
5/66 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
1.5%
1/65 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.6%
7/66 • Number of events 16 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
4.6%
3/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
7.6%
5/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Blood bilirubin increased
|
6.1%
4/66 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Blood creatinine increased
|
7.6%
5/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/66 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Platelet count decreased
|
7.6%
5/66 • Number of events 9 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Investigations
Weight decreased
|
10.6%
7/66 • Number of events 13 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
29.2%
19/65 • Number of events 30 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.2%
14/66 • Number of events 17 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
36.9%
24/65 • Number of events 45 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
6/66 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
16.9%
11/65 • Number of events 15 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.6%
5/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
4.6%
3/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
2/66 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
3/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
10/66 • Number of events 13 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
13.8%
9/65 • Number of events 12 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
11/66 • Number of events 23 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
36.9%
24/65 • Number of events 27 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
3/66 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.6%
5/66 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
15.4%
10/65 • Number of events 12 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
6/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
9.2%
6/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
11/66 • Number of events 13 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
16.9%
11/65 • Number of events 13 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
3/66 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 12 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
6/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
21.5%
14/65 • Number of events 22 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Dizziness
|
21.2%
14/66 • Number of events 18 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
18.5%
12/65 • Number of events 16 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Dysgeusia
|
4.5%
3/66 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
15.4%
10/65 • Number of events 11 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Headache
|
24.2%
16/66 • Number of events 20 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
24.6%
16/65 • Number of events 23 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Memory impairment
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Paraesthesia
|
3.0%
2/66 • Number of events 3 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.6%
5/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Nervous system disorders
Tremor
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
0.00%
0/65 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
3.1%
2/65 • Number of events 2 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Psychiatric disorders
Confusional state
|
6.1%
4/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Psychiatric disorders
Insomnia
|
9.1%
6/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
6.2%
4/65 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.8%
17/66 • Number of events 19 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
23.1%
15/65 • Number of events 20 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
38.5%
25/65 • Number of events 26 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.7%
13/66 • Number of events 19 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
27.7%
18/65 • Number of events 21 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.2%
14/66 • Number of events 23 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/66 • Number of events 1 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
7.7%
5/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
4/66 • Number of events 4 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
9.2%
6/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
4/66 • Number of events 8 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
10.8%
7/65 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.6%
5/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
4.6%
3/65 • Number of events 5 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Hypertension
|
6.1%
4/66 • Number of events 10 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
41.5%
27/65 • Number of events 48 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
|
Vascular disorders
Hypotension
|
6.1%
4/66 • Number of events 6 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
9.2%
6/65 • Number of events 7 • From first dose up to 53 months
All-cause mortality data was reported for FAS population. Serious and non-serious adverse events were reported for safety population.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER