Trial Outcomes & Findings for A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT01846611)
NCT ID: NCT01846611
Last Updated: 2019-04-01
Results Overview
OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
581 participants
Primary outcome timeframe
Up to 4.3 years
Results posted on
2019-04-01
Participant Flow
Total 581 participants were enrolled. Out of which 5 participants who were enrolled at the time of study termination were not assigned to any treatment group. Therefore, these 5 participants were not considered as randomized participants and excluded from result analysis.
Participant milestones
| Measure |
Trabectedin + DOXIL
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
287
|
|
Overall Study
Treated
|
286
|
282
|
|
Overall Study
COMPLETED
|
251
|
244
|
|
Overall Study
NOT COMPLETED
|
38
|
43
|
Reasons for withdrawal
| Measure |
Trabectedin + DOXIL
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
15
|
19
|
|
Overall Study
Other
|
19
|
18
|
Baseline Characteristics
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Trabectedin + DOXIL
n=289 Participants
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=287 Participants
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 10.35 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
576 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
270 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
248 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
494 Participants
n=5 Participants
|
|
Region of Enrollment
AUSTRALIA
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
CHINA
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
ISRAEL
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
NEW ZEALAND
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
124 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
SWITZERLAND
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
103 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4.3 yearsPopulation: All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.
OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
Outcome measures
| Measure |
Trabectedin + DOXIL
n=289 Participants
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=287 Participants
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
23.82 months
Interval 20.3 to 26.12
|
22.21 months
Interval 18.1 to 24.67
|
SECONDARY outcome
Timeframe: Up to 4.3 yearsPopulation: All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.
PFS is defined as the time between the date of randomization and the date of disease progression or death. PFS was assessed using the response evaluation criteria in solid tumors (RECIST) Version 1.1. As per criteria progressive disease in case of target lesions means at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Progressive disease in case of non-target lesions means unequivocal progression of existing non-target lesions. In both cases the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Trabectedin + DOXIL
n=289 Participants
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=287 Participants
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
7.52 months
Interval 6.93 to 9.43
|
7.26 months
Interval 6.14 to 7.59
|
SECONDARY outcome
Timeframe: Up to 4.3 yearsPopulation: All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.
ORR is defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Trabectedin + DOXIL
n=289 Participants
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=287 Participants
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
46.0 Percentage of participants
Interval 40.2 to 52.0
|
35.9 Percentage of participants
Interval 30.3 to 41.7
|
Adverse Events
Trabectedin + DOXIL
Serious events: 118 serious events
Other events: 282 other events
Deaths: 132 deaths
DOXIL
Serious events: 58 serious events
Other events: 273 other events
Deaths: 131 deaths
Serious adverse events
| Measure |
Trabectedin + DOXIL
n=286 participants at risk
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=282 participants at risk
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.9%
14/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral Pruritus
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.0%
14/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter Site Inflammation
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Chest Discomfort
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza Like Illness
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device Related Infection
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device Related Sepsis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterobacter Bacteraemia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis Bacterial
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic Shock
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Soft Tissue Infection
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Anastomotic Ulcer
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.9%
14/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection Fraction Decreased
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet Count Decreased
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases Increased
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Abdominal Wall
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Product Issues
Device Malfunction
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Failure
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic Fluid Collection
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Capillary Leak Syndrome
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.70%
2/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.00%
0/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Trabectedin + DOXIL
n=286 participants at risk
Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV.
|
DOXIL
n=282 participants at risk
Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
47.2%
135/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
24.8%
70/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.5%
53/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
13.5%
38/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.1%
149/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
36.9%
104/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.0%
63/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
6.4%
18/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.0%
20/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.3%
15/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.9%
54/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
15.6%
44/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
6.0%
17/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
28.7%
82/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
21.6%
61/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
59/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
16.7%
47/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.5%
10/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
23/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
6.4%
18/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.3%
15/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.0%
14/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
74.1%
212/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
40.4%
114/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral Pain
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.5%
10/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
52/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
32.3%
91/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
49.3%
141/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
19.1%
54/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
13.6%
39/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
59.8%
171/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
40.1%
113/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal Inflammation
|
7.7%
22/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
11.7%
33/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
11.2%
32/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
7.8%
22/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral Swelling
|
3.1%
9/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
13.3%
38/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
9.2%
26/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.9%
14/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.3%
15/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.9%
11/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
52.8%
151/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
4.3%
12/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
35.0%
100/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.9%
11/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Bilirubin Conjugated Increased
|
8.4%
24/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
25.5%
73/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
8.4%
24/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
4.5%
13/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.2%
9/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
7.0%
20/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
7.4%
21/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Urea Increased
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection Fraction Decreased
|
7.0%
20/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.5%
10/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
4.5%
13/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin Decreased
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.35%
1/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte Count Decreased
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
18.2%
52/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
13.1%
37/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet Count Decreased
|
18.2%
52/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
4.5%
13/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
11.5%
33/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
10.3%
29/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
29.0%
83/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
18.4%
52/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
21/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.2%
9/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.3%
21/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
22/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
4.3%
12/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.6%
19/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.9%
14/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
25/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
4.3%
12/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.4%
24/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.3%
15/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
0.71%
2/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.6%
16/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
3.2%
9/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.4%
4/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
16/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness Postural
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
12.2%
35/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
7.1%
20/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
13.3%
38/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
10.3%
29/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy Peripheral
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
4.6%
13/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
6.3%
18/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.0%
14/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.6%
19/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.7%
16/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
0.35%
1/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
41/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
12.1%
34/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
44/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
9.9%
28/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.1%
3/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
12/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.0%
14/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.6%
16/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
6.0%
17/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.8%
5/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
6/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.2%
32/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
7.8%
22/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
22/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
7.4%
21/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
20.3%
58/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
41.5%
117/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
1.7%
5/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
5.0%
14/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
22/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
9.2%
26/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
2.8%
8/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
8.5%
24/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
3.5%
10/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
4.3%
12/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
1.0%
3/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.1%
6/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot Flush
|
2.4%
7/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.8%
8/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.7%
22/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
2.5%
7/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
3.8%
11/286 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
1.4%
4/282 • Up to 4.3 years
Safety population included all-treated participants who received at least 1 dose of study drug.
|
Additional Information
Senior Medical Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER