Trial Outcomes & Findings for Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients (NCT NCT02825420)
NCT ID: NCT02825420
Last Updated: 2021-10-29
Results Overview
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Target enrollment
220 participants
Primary outcome timeframe
From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Results posted on
2021-10-29
Participant Flow
A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit.
Participant milestones
| Measure |
Prior Use of Antiangiogenics
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
89
|
|
Overall Study
COMPLETED
|
88
|
72
|
|
Overall Study
NOT COMPLETED
|
43
|
17
|
Reasons for withdrawal
| Measure |
Prior Use of Antiangiogenics
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Study
Death
|
30
|
12
|
|
Overall Study
Progressive disease
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol amendment not signed
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Did not receive PLD
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prior Use of Antiangiogenics
n=129 Participants
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
No Prior Use of Antiangiogenics
n=89 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=129 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=218 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=129 Participants
|
54 Participants
n=89 Participants
|
129 Participants
n=218 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=129 Participants
|
35 Participants
n=89 Participants
|
89 Participants
n=218 Participants
|
|
Age, Continuous
|
61.0 years
n=129 Participants
|
61.0 years
n=89 Participants
|
61.0 years
n=218 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=129 Participants
|
89 Participants
n=89 Participants
|
218 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=129 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
10 Participants
n=129 Participants
|
2 Participants
n=89 Participants
|
12 Participants
n=218 Participants
|
|
Region of Enrollment
Italy
|
57 Participants
n=129 Participants
|
37 Participants
n=89 Participants
|
94 Participants
n=218 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=129 Participants
|
5 Participants
n=89 Participants
|
14 Participants
n=218 Participants
|
|
Region of Enrollment
Germany
|
16 Participants
n=129 Participants
|
2 Participants
n=89 Participants
|
18 Participants
n=218 Participants
|
|
Region of Enrollment
Spain
|
39 Participants
n=129 Participants
|
43 Participants
n=89 Participants
|
82 Participants
n=218 Participants
|
|
Weight
|
64.0 Kg
n=116 Participants • 19 patients not evaluated
|
68.0 Kg
n=83 Participants • 19 patients not evaluated
|
65.0 Kg
n=199 Participants • 19 patients not evaluated
|
|
Height
|
160 cm
n=116 Participants • 19 patients not evaluated
|
158 cm
n=83 Participants • 19 patients not evaluated
|
160 cm
n=199 Participants • 19 patients not evaluated
|
|
Calculated body surface area
|
1.7 m^2
n=113 Participants • 24 patients not evaluated
|
1.7 m^2
n=81 Participants • 24 patients not evaluated
|
1.7 m^2
n=194 Participants • 24 patients not evaluated
|
|
Investigator reported body surface area
|
1.6 m^2
n=113 Participants • 24 patients not evaluated
|
1.7 m^2
n=81 Participants • 24 patients not evaluated
|
1.7 m^2
n=194 Participants • 24 patients not evaluated
|
|
Tumor grade at diagnosis
High grade
|
95 Participants
n=129 Participants
|
61 Participants
n=89 Participants
|
156 Participants
n=218 Participants
|
|
Tumor grade at diagnosis
Intermediate grade
|
9 Participants
n=129 Participants
|
5 Participants
n=89 Participants
|
14 Participants
n=218 Participants
|
|
Tumor grade at diagnosis
Low grade
|
6 Participants
n=129 Participants
|
6 Participants
n=89 Participants
|
12 Participants
n=218 Participants
|
|
Tumor grade at diagnosis
Not done/not reported/unknown
|
19 Participants
n=129 Participants
|
17 Participants
n=89 Participants
|
36 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Papillary/serous
|
97 Participants
n=129 Participants
|
60 Participants
n=89 Participants
|
157 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Endometroid
|
6 Participants
n=129 Participants
|
8 Participants
n=89 Participants
|
14 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Clear cell carcinoma
|
6 Participants
n=129 Participants
|
4 Participants
n=89 Participants
|
10 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Peritoneal carcinoma
|
6 Participants
n=129 Participants
|
3 Participants
n=89 Participants
|
9 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Mixed epithelial tumour
|
4 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
5 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Mucinous
|
2 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
3 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Undifferentiated carcinoma
|
2 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
3 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Fallopian tube carcinoma
|
0 Participants
n=129 Participants
|
2 Participants
n=89 Participants
|
2 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Transitional carcinoma (brenner)
|
0 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
1 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Transitional carcinoma (no brenner)
|
0 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
1 Participants
n=218 Participants
|
|
Histopathology at initial ovarian cancer diagnosis
Unknown
|
6 Participants
n=129 Participants
|
7 Participants
n=89 Participants
|
13 Participants
n=218 Participants
|
|
Platinum sensitivity
Partially Platinum Sensitive
|
80 Participants
n=129 Participants
|
47 Participants
n=89 Participants
|
127 Participants
n=218 Participants
|
|
Platinum sensitivity
Fully Platinum Sensitive
|
48 Participants
n=129 Participants
|
41 Participants
n=89 Participants
|
89 Participants
n=218 Participants
|
|
Platinum sensitivity
Missing
|
1 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
2 Participants
n=218 Participants
|
|
BRCA 1/2 status tested
Positive
|
15 Participants
n=129 Participants
|
19 Participants
n=89 Participants
|
34 Participants
n=218 Participants
|
|
BRCA 1/2 status tested
Negative
|
68 Participants
n=129 Participants
|
32 Participants
n=89 Participants
|
100 Participants
n=218 Participants
|
|
BRCA 1/2 status tested
Unknown
|
1 Participants
n=129 Participants
|
0 Participants
n=89 Participants
|
1 Participants
n=218 Participants
|
|
BRCA 1/2 status tested
Not tested
|
45 Participants
n=129 Participants
|
38 Participants
n=89 Participants
|
83 Participants
n=218 Participants
|
|
ECOG performance status
PS 0
|
63 Participants
n=129 Participants
|
45 Participants
n=89 Participants
|
108 Participants
n=218 Participants
|
|
ECOG performance status
PS 1
|
41 Participants
n=129 Participants
|
15 Participants
n=89 Participants
|
56 Participants
n=218 Participants
|
|
ECOG performance status
PS 2
|
3 Participants
n=129 Participants
|
3 Participants
n=89 Participants
|
6 Participants
n=218 Participants
|
|
ECOG performance status
Missing
|
22 Participants
n=129 Participants
|
26 Participants
n=89 Participants
|
48 Participants
n=218 Participants
|
|
Prior surgery
|
118 Participants
n=129 Participants
|
81 Participants
n=89 Participants
|
199 Participants
n=218 Participants
|
|
Surgery residual disease
|
58 Participants
n=129 Participants
|
26 Participants
n=89 Participants
|
84 Participants
n=218 Participants
|
|
Prior radiotherapy
|
4 Participants
n=129 Participants
|
3 Participants
n=89 Participants
|
7 Participants
n=218 Participants
|
|
Prior chemotherapy
|
129 Participants
n=129 Participants
|
88 Participants
n=89 Participants
|
217 Participants
n=218 Participants
|
|
Number of prior chemotherapy lines
None
|
0 Participants
n=129 Participants
|
1 Participants
n=89 Participants
|
1 Participants
n=218 Participants
|
|
Number of prior chemotherapy lines
1 prior line
|
22 Participants
n=129 Participants
|
37 Participants
n=89 Participants
|
59 Participants
n=218 Participants
|
|
Number of prior chemotherapy lines
2 prior lines
|
48 Participants
n=129 Participants
|
23 Participants
n=89 Participants
|
71 Participants
n=218 Participants
|
|
Number of prior chemotherapy lines
3 prior lines
|
32 Participants
n=129 Participants
|
11 Participants
n=89 Participants
|
43 Participants
n=218 Participants
|
|
Number of prior chemotherapy lines
4-8 prior lines
|
27 Participants
n=129 Participants
|
17 Participants
n=89 Participants
|
44 Participants
n=218 Participants
|
|
Best response to prior therapy regimen
Complete Response
|
24 Participants
n=129 Participants
|
31 Participants
n=89 Participants
|
55 Participants
n=218 Participants
|
|
Best response to prior therapy regimen
Partial Response
|
31 Participants
n=129 Participants
|
23 Participants
n=89 Participants
|
54 Participants
n=218 Participants
|
|
Best response to prior therapy regimen
Stable Disease
|
36 Participants
n=129 Participants
|
12 Participants
n=89 Participants
|
48 Participants
n=218 Participants
|
|
Best response to prior therapy regimen
Disease recurrence/Progression disease
|
26 Participants
n=129 Participants
|
6 Participants
n=89 Participants
|
32 Participants
n=218 Participants
|
|
Best response to prior therapy regimen
Not Evaluable/Not done/Unknown
|
12 Participants
n=129 Participants
|
17 Participants
n=89 Participants
|
29 Participants
n=218 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Full Analysis Set
n=218 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Progression-Free Survival
|
9.46 months
Interval 7.9 to 10.9
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Full Analysis Set
n=129 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=89 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Progression Free Survival by Prior Antiangiogenic Treatment
|
7.59 months
Interval 6.4 to 10.0
|
12.45 months
Interval 9.4 to 14.3
|
PRIMARY outcome
Timeframe: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Full Analysis Set
n=34 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=100 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Progression Free Survival by BRCA1/2 Status
|
9.23 months
Interval 6.0 to 17.1
|
8.97 months
Interval 7.1 to 10.3
|
PRIMARY outcome
Timeframe: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Full Analysis Set
n=89 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=127 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Progression Free Survival by Platinum Sensitivity
|
9.26 months
Interval 7.1 to 12.5
|
9.46 months
Interval 7.4 to 11.4
|
SECONDARY outcome
Timeframe: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Full Analysis Set
n=218 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Best Tumor Response
Complete response
|
24 Participants
|
—
|
|
Best Tumor Response
Partial response
|
57 Participants
|
—
|
|
Best Tumor Response
Stable disease
|
59 Participants
|
—
|
|
Best Tumor Response
Progressive disease
|
62 Participants
|
—
|
|
Best Tumor Response
Not evaluable/Not done
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Full Analysis Set
n=129 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=89 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Best Response by Prior Antiangiogenic Treatment
Progressive disease
|
46 Participants
|
16 Participants
|
|
Best Response by Prior Antiangiogenic Treatment
Stable disease
|
32 Participants
|
27 Participants
|
|
Best Response by Prior Antiangiogenic Treatment
Partial response
|
27 Participants
|
30 Participants
|
|
Best Response by Prior Antiangiogenic Treatment
Complete response
|
11 Participants
|
13 Participants
|
|
Best Response by Prior Antiangiogenic Treatment
Not evaluable/Not done
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Outcome measures
| Measure |
Full Analysis Set
n=218 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Survival
|
23.56 months
Interval 18.1 to 34.1
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Outcome measures
| Measure |
Full Analysis Set
n=129 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=89 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Survival by Prior Antiangiogenic Treatment
|
21.85 months
Interval 16.7 to 39.6
|
26.28 months
Interval 18.1 to 40.1
|
SECONDARY outcome
Timeframe: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Outcome measures
| Measure |
Full Analysis Set
n=34 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=100 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Survival by BRCA1/2 Status
|
23.56 months
Interval 16.1 to 40.1
|
21.85 months
Interval 16.7 to
Not reached: the last observation is censored
|
SECONDARY outcome
Timeframe: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Outcome measures
| Measure |
Full Analysis Set
n=89 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=127 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Overall Survival by Platinum Sensitivity
|
23.56 months
Interval 16.7 to 34.1
|
26.05 months
Interval 17.7 to 39.6
|
SECONDARY outcome
Timeframe: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Outcome measures
| Measure |
Full Analysis Set
n=218 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score
Missing
|
55 Participants
|
—
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score
Less than 0 (improvement)
|
24 Participants
|
—
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score
0 (no change)
|
125 Participants
|
—
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score
More than 0 to 2 (deterioration)
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Outcome measures
| Measure |
Full Analysis Set
n=129 Participants
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
|
No Prior Use of Antiangiogenics
n=89 Participants
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
Less than 0 (improvement)
|
14 Participants
|
10 Participants
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
0 (no change)
|
83 Participants
|
42 Participants
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
More than 0 to 2 (deterioration)
|
5 Participants
|
9 Participants
|
|
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
Missing
|
27 Participants
|
28 Participants
|
Adverse Events
Prior Use of Antiangiogenics
Serious events: 23 serious events
Other events: 106 other events
Deaths: 30 deaths
No Prior Use of Antiangiogenics
Serious events: 14 serious events
Other events: 78 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Prior Use of Antiangiogenics
n=129 participants at risk
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
No Prior Use of Antiangiogenics
n=89 participants at risk
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
3/129 • Number of events 3 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
4/129 • Number of events 4 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
4.5%
4/89 • Number of events 4 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.9%
5/129 • Number of events 7 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
4.5%
4/89 • Number of events 4 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.6%
2/129 • Number of events 2 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
4/129 • Number of events 5 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Dysphagia
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Oesophagitis
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Retching
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
4/129 • Number of events 6 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 3 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Asthenia
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Disease progression
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Fatigue
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Oedema
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Pyrexia
|
1.6%
2/129 • Number of events 2 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Immune system disorders
Drug hypersensitivity
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Device related infection
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Escherichia infection
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Infusion site infection
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Pneumonia
|
1.6%
2/129 • Number of events 2 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Respiratory tract infection
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Sepsis
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Urosepsis
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Investigations
Blood alkaline phosphatase increased
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Investigations
Blood electrolytes decreased
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Investigations
Platelet count decreased
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Investigations
Transaminases increased
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
1/129 • Number of events 2 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Nervous system disorders
Convulsion
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Renal and urinary disorders
Azotaemia
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/129 • Number of events 4 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
0.00%
0/89 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Surgical and medical procedures
Off label use
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Vascular disorders
Embolism
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/129 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
1.1%
1/89 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
Other adverse events
| Measure |
Prior Use of Antiangiogenics
n=129 participants at risk
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
No Prior Use of Antiangiogenics
n=89 participants at risk
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.9%
45/129 • Number of events 99 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
28.1%
25/89 • Number of events 48 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.0%
18/129 • Number of events 36 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
7.9%
7/89 • Number of events 22 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.2%
57/129 • Number of events 162 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
51.7%
46/89 • Number of events 152 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.1%
22/129 • Number of events 34 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
6.7%
6/89 • Number of events 14 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Constipation
|
11.6%
15/129 • Number of events 22 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
13.5%
12/89 • Number of events 15 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
10/129 • Number of events 12 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
9.0%
8/89 • Number of events 10 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Nausea
|
30.2%
39/129 • Number of events 63 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
29.2%
26/89 • Number of events 36 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Stomatitis
|
3.9%
5/129 • Number of events 5 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
5.6%
5/89 • Number of events 6 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
30/129 • Number of events 42 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
16.9%
15/89 • Number of events 19 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Asthenia
|
27.1%
35/129 • Number of events 64 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
41.6%
37/89 • Number of events 61 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Fatigue
|
8.5%
11/129 • Number of events 11 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
5.6%
5/89 • Number of events 6 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
General disorders
Mucosal inflammation
|
7.8%
10/129 • Number of events 16 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
16.9%
15/89 • Number of events 22 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Investigations
Neutrophil count decreased
|
7.0%
9/129 • Number of events 30 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
7.9%
7/89 • Number of events 13 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.1%
13/129 • Number of events 21 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
9.0%
8/89 • Number of events 8 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.1%
4/129 • Number of events 6 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
13.5%
12/89 • Number of events 17 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.78%
1/129 • Number of events 1 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
5.6%
5/89 • Number of events 5 • From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
|
Additional Information
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Pharma Mar S.A.
Phone: 0034 91846 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER