Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer (NCT NCT02289950)
NCT ID: NCT02289950
Last Updated: 2021-09-02
Results Overview
PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
332 participants
Primary outcome timeframe
From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months
Results posted on
2021-09-02
Participant Flow
Participants took part in the study at 60 investigative sites in the United states, Belgium, Germany, Italy, Spain, United Kingdom and Japan from 19 March 2015 to 13 August 2020.
A total of 332 participants were screened, of which 118 were screen failures and 214 were randomized out of which 211 were treated. .
Participant milestones
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
72
|
|
Overall Study
Treated
|
140
|
71
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
142
|
72
|
Reasons for withdrawal
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Overall Study
Progressive disease by RECIST 1.1
|
99
|
52
|
|
Overall Study
Progressive disease by Clinical Assessment
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
9
|
3
|
|
Overall Study
Subject chose to discontinue therapy but will continue to survival follow-up
|
9
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Test article held for greater than 28 days
|
0
|
1
|
|
Overall Study
Adverse Event
|
11
|
3
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Other
|
5
|
2
|
|
Overall Study
Not Treated
|
2
|
1
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=142 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=72 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 10.74 • n=93 Participants
|
62.9 years
STANDARD_DEVIATION 10.50 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 10.64 • n=27 Participants
|
|
Sex/Gender, Customized
Females
|
141 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
213 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
194 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 monthsPopulation: The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.
PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=142 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=72 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.73 Months
Interval 10.22 to 13.6
|
10.78 Months
Interval 9.49 to 13.17
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death (up to approximately 5 years 5 months)Population: The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.
OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=142 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=72 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Overall Survival (OS)
|
43.07 Months
Interval 37.13 to
Here, NA means that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
|
42.45 Months
Interval 37.85 to
Here, NA means that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From first dose of study drug (Baseline) up to approximately 5 years 5 monthsPopulation: Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed.
BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(\>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(\<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=138 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=68 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Number of Participants With Best Overall Response (BOR)
Complete Response
|
24 Participants
|
15 Participants
|
|
Number of Participants With Best Overall Response (BOR)
Partial Response
|
72 Participants
|
35 Participants
|
|
Number of Participants With Best Overall Response (BOR)
Stable Disease
|
36 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 monthsPopulation: Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here "overall number of participants analyzed" signifies participants who had CR or PR.
TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=96 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=50 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Time to Tumor Response (TTR)
|
2.69 months
Interval 1.74 to 2.83
|
2.53 months
Interval 1.48 to 2.69
|
SECONDARY outcome
Timeframe: From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 monthsPopulation: Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here "overall number of participants analyzed" signifies participants who had CR or PR.
DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=96 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=50 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Duration of Response (DOR)
|
10.12 months
Interval 8.54 to 11.47
|
8.51 months
Interval 6.31 to 10.97
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 monthsPopulation: The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.
Percentage of participants achieving each second platinum-free interval (\<6 months, 6-12 months, greater than \[\>\] 12-36 months, and \>36 months) stratified by first platinum-free interval (6 to 12 months and \>12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable).
Outcome measures
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=142 Participants
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=72 Participants
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (>12-36 months): First platinum free interval (6 to 12 months)
|
16.9 percentage of participants
Interval 8.44 to 28.97
|
10.0 percentage of participants
Interval 2.11 to 26.53
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (>36 months): First platinum free interval (6 to 12 months)
|
0.00 percentage of participants
Interval 0.0 to 6.06
|
0.0 percentage of participants
Interval 0.0 to 11.57
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (<6 months): First platinum free interval (>12 to 36 months)
|
42.2 percentage of participants
Interval 31.4 to 53.51
|
52.4 percentage of participants
Interval 36.42 to 68.0
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (>12-36 months): First platinum free interval (>12 to 36 months)
|
20.5 percentage of participants
Interval 12.41 to 30.76
|
16.7 percentage of participants
Interval 6.97 to 31.36
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (<6 months): First platinum free interval (6 to 12 months)
|
71.2 percentage of participants
Interval 57.92 to 82.24
|
63.3 percentage of participants
Interval 43.86 to 80.07
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (6-12 months): First platinum free interval (6 to 12 months)
|
6.8 percentage of participants
Interval 1.88 to 16.46
|
23.3 percentage of participants
Interval 9.93 to 42.28
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (>36 months): First platinum free interval (>12 to 36 months)
|
0.0 percentage of participants
Interval 0.0 to 4.35
|
0.0 percentage of participants
Interval 0.0 to 8.41
|
|
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Second platinum free interval (6-12 months): First platinum free interval (>12 to 36 months)
|
33.7 percentage of participants
Interval 23.72 to 44.95
|
28.6 percentage of participants
Interval 15.72 to 44.58
|
Adverse Events
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
Serious events: 42 serious events
Other events: 140 other events
Deaths: 1 deaths
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
Serious events: 18 serious events
Other events: 70 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=141 participants at risk
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=70 participants at risk
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
7/141 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Stomatitis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
6/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Constipation
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/141 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.5%
5/141 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/141 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Chest pain
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Influenza like illness
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Malaise
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Non-cardiac chest pain
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Pyrexia
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Immune system disorders
Drug hypersensitivity
|
0.71%
1/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Lung infection
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Pneumonia
|
1.4%
2/141 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Tracheitis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Bacteraemia
|
0.71%
1/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.71%
1/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Lipase increased
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Platelet count decreased
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Hemiparesis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Ischaemic stroke
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Confusional state
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
2/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
1/141 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hypertensive crisis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/70 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Other adverse events
| Measure |
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
n=141 participants at risk
Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
|
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
n=70 participants at risk
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
17/141 • Number of events 22 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
17.1%
12/70 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Dizziness
|
15.6%
22/141 • Number of events 40 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
18.6%
13/70 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Dysgeusia
|
10.6%
15/141 • Number of events 22 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
17.1%
12/70 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Headache
|
34.8%
49/141 • Number of events 77 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
38.6%
27/70 • Number of events 61 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.6%
15/141 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
6/141 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Anaemia
|
53.9%
76/141 • Number of events 208 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
51.4%
36/70 • Number of events 121 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.0%
55/141 • Number of events 225 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
34.3%
24/70 • Number of events 82 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.9%
21/141 • Number of events 74 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 20 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.8%
42/141 • Number of events 109 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
27.1%
19/70 • Number of events 86 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.4%
9/141 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
9/141 • Number of events 12 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
27.7%
39/141 • Number of events 65 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
31.4%
22/70 • Number of events 34 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.1%
17/141 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
17.1%
12/70 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Constipation
|
41.1%
58/141 • Number of events 93 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
44.3%
31/70 • Number of events 53 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.0%
48/141 • Number of events 83 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
38.6%
27/70 • Number of events 63 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Dry mouth
|
6.4%
9/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
12/141 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
14.3%
10/70 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.5%
12/141 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
67.4%
95/141 • Number of events 187 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
64.3%
45/70 • Number of events 110 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Stomatitis
|
31.2%
44/141 • Number of events 66 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
34.3%
24/70 • Number of events 51 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
30.5%
43/141 • Number of events 74 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
38.6%
27/70 • Number of events 56 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Ear and labyrinth disorders
Ear pain
|
2.1%
3/141 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Ear and labyrinth disorders
Vertigo
|
5.7%
8/141 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Eye disorders
Vision blurred
|
5.0%
7/141 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Asthenia
|
23.4%
33/141 • Number of events 90 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
20.0%
14/70 • Number of events 42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Chills
|
4.3%
6/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Fatigue
|
48.9%
69/141 • Number of events 112 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
50.0%
35/70 • Number of events 55 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Influenza like illness
|
5.7%
8/141 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Malaise
|
6.4%
9/141 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Oedema peripheral
|
11.3%
16/141 • Number of events 21 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
17.1%
12/70 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Peripheral swelling
|
2.8%
4/141 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Pyrexia
|
16.3%
23/141 • Number of events 37 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
15.7%
11/70 • Number of events 16 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Immune system disorders
Drug hypersensitivity
|
2.8%
4/141 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Cystitis
|
4.3%
6/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Influenza
|
6.4%
9/141 • Number of events 12 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
22/141 • Number of events 34 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
20.0%
14/70 • Number of events 26 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Sinusitis
|
7.1%
10/141 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.4%
8/70 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.3%
23/141 • Number of events 29 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Urinary tract infection
|
12.8%
18/141 • Number of events 24 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.9%
16/70 • Number of events 32 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
7/141 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
10/141 • Number of events 16 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Neutrophil count decreased
|
31.2%
44/141 • Number of events 165 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
25.7%
18/70 • Number of events 90 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Platelet count decreased
|
19.1%
27/141 • Number of events 83 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
15.7%
11/70 • Number of events 46 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
White blood cell count decreased
|
24.1%
34/141 • Number of events 127 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
20.0%
14/70 • Number of events 68 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.9%
28/141 • Number of events 43 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
25.7%
18/70 • Number of events 32 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.2%
13/141 • Number of events 21 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
7/141 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.0%
7/141 • Number of events 12 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.3%
23/141 • Number of events 49 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.9%
21/141 • Number of events 33 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.5%
36/141 • Number of events 52 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
21.4%
15/70 • Number of events 27 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.71%
1/141 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
18/141 • Number of events 24 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
25.7%
18/70 • Number of events 24 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
6/141 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.1%
3/141 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
8/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
15.7%
11/70 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
3/141 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.4%
9/141 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.4%
1/70 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.2%
13/141 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Paraesthesia
|
7.8%
11/141 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.4%
8/70 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.3%
23/141 • Number of events 31 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
20.0%
14/70 • Number of events 21 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Anxiety
|
10.6%
15/141 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Depression
|
4.3%
6/141 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.6%
6/70 • Number of events 16 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Insomnia
|
10.6%
15/141 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.4%
8/70 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Dysuria
|
7.8%
11/141 • Number of events 16 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.5%
43/141 • Number of events 65 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.9%
16/70 • Number of events 25 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.0%
31/141 • Number of events 47 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
7/141 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
10/141 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
2.9%
2/70 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.3%
16/141 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.0%
7/70 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.4%
26/141 • Number of events 29 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
21.4%
15/70 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/141 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
4/141 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.4%
9/141 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
2.8%
4/141 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.7%
4/70 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.8%
11/141 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
15/141 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.0%
24/141 • Number of events 38 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
18.6%
13/70 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hot flush
|
2.8%
4/141 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.9%
9/70 • Number of events 17 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hypertension
|
5.0%
7/141 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.1%
5/70 • Number of events 14 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place