Trial Outcomes & Findings for SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (NCT NCT02807181)
NCT ID: NCT02807181
Last Updated: 2025-05-09
Results Overview
Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
89 participants
Primary outcome timeframe
18 months following the date of randomization.
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
41
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
37
|
32
|
Reasons for withdrawal
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Overall Study
Death
|
28
|
24
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Subject decision
|
1
|
0
|
|
Overall Study
Biopsy of tumor removed from resection
|
1
|
0
|
|
Overall Study
In Study
|
3
|
3
|
|
Overall Study
Post Progression
|
3
|
2
|
Baseline Characteristics
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=48 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=41 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Continuous
|
61.94 years
n=5 Participants
|
67.17 years
n=7 Participants
|
64.35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
France
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Extra-hepatic disease
Present
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Extra-hepatic disease
Absent
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
ECOG Performance Scale
0
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
ECOG Performance Scale
1
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Cirrhosis
Present
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cirrhosis
Absent
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Extent of liver involvement
Non-whole
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Extent of liver involvement
Whole
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Prior Treatment
Yes
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Prior Treatment
No
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months following the date of randomization.Population: Randomized Population
Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=48 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=41 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Survival at 18 Months
Yes
|
25 Participants
|
23 Participants
|
|
Survival at 18 Months
No
|
23 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months..Population: The data set we received for analysis showed only 17 CIS-GEM participants and 16 SIRT+CIS GEM participants with reported liver tumor progression data available. Due to database issues, the validity and reliability of this data is not complete.
Liver-specific PFS was defined as the number of days between randomization and the date of first tumor progression in the liver. Diagnosis of tumor progression was to be made using RECIST 1.1.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=17 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=16 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Liver-specific Progression Free Survival (PFS)
|
323 Days to first tumor progression
Interval 82.0 to 712.0
|
369 Days to first tumor progression
Interval 102.0 to 875.0
|
SECONDARY outcome
Timeframe: From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months.Population: The data set we received for analysis showed 38 CIS-GEM participants and 27 SIRT+CIS GEM participants with reported tumor progression data available for any site. Due to database issues, the validity and reliability of this data is not complete
PFS was defined as the time interval between randomization and the date of tumor progression. Diagnosis of tumor progression was to be made using RECIST 1.1. The outcome was not analyzed due to unreliability of the clinical database.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=38 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=27 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Progression Free Survival (PFS) at Any Site
|
332 Days to tumor progression
Interval 40.0 to 712.0
|
424 Days to tumor progression
Interval 102.0 to 875.0
|
SECONDARY outcome
Timeframe: From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.Population: The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete.
The outcome was not analyzed due to unreliability of the clinical database.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=396 Number of Responses (RECIST 1.1+RRECIST)
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=416 Number of Responses (RECIST 1.1+RRECIST)
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Complete Response (CR) : RECIST 1.1
|
22 Number of Responses (RECIST 1.1+RRECIST)
|
10 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Complete Response (CR) : Refined RECIST
|
21 Number of Responses (RECIST 1.1+RRECIST)
|
10 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Partial Response (PR) : RECIST 1.1
|
25 Number of Responses (RECIST 1.1+RRECIST)
|
58 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Partial Response (PR) : Refined RECIST
|
24 Number of Responses (RECIST 1.1+RRECIST)
|
56 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Progressive Disease (PD) : RECIST 1.1
|
23 Number of Responses (RECIST 1.1+RRECIST)
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Progressive Disease (PD) : Refined RECIST
|
22 Number of Responses (RECIST 1.1+RRECIST)
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Stable Disease (SD) : RECIST 1.1
|
113 Number of Responses (RECIST 1.1+RRECIST)
|
110 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Stable Disease (SD) : Refined RECIST
|
105 Number of Responses (RECIST 1.1+RRECIST)
|
105 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Not Evaluable : RECIST 1.1
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
8 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Not Evaluable : Refined RECIST
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
8 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Incomplete Form : RECIST 1.1
|
2 Number of Responses (RECIST 1.1+RRECIST)
|
9 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Incomplete Form : Refined RECIST
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
16 Number of Responses (RECIST 1.1+RRECIST)
|
SECONDARY outcome
Timeframe: From the date of first treatment until progression at any site, assessed up to 36 months.Population: The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete.
The outcome was not analyzed due to unreliability of the clinical database.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=396 Number of Responses (RECIST 1.1+RRECIST)
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=416 Number of Responses (RECIST 1.1+RRECIST)
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Complete Response (CR) : RECIST 1.1
|
22 Number of Responses (RECIST 1.1+RRECIST)
|
8 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Complete Response (CR) : Refined RECIST
|
22 Number of Responses (RECIST 1.1+RRECIST)
|
7 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Partial Response (PR) : RECIST 1.1
|
28 Number of Responses (RECIST 1.1+RRECIST)
|
28 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Partial Response (PR) : Refined RECIST
|
27 Number of Responses (RECIST 1.1+RRECIST)
|
48 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Progressive Disease (PD) : RECIST 1.1
|
42 Number of Responses (RECIST 1.1+RRECIST)
|
42 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Progressive Disease (PD) : Refined RECIST
|
38 Number of Responses (RECIST 1.1+RRECIST)
|
34 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Stable Disease (SD) : RECIST 1.1
|
103 Number of Responses (RECIST 1.1+RRECIST)
|
102 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Stable Disease (SD) : Refined RECIST
|
98 Number of Responses (RECIST 1.1+RRECIST)
|
96 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Not Evaluable : RECIST 1.1
|
1 Number of Responses (RECIST 1.1+RRECIST)
|
7 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Not Evaluable : Refined RECIST
|
0 Number of Responses (RECIST 1.1+RRECIST)
|
7 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Incomplete Form : RECIST 1.1
|
2 Number of Responses (RECIST 1.1+RRECIST)
|
9 Number of Responses (RECIST 1.1+RRECIST)
|
|
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Incomplete Form : Refined RECIST
|
13 Number of Responses (RECIST 1.1+RRECIST)
|
16 Number of Responses (RECIST 1.1+RRECIST)
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 36 months.Population: Overall survival data assessed until 36 months can be calculated for 42 CIS GEM participants and 36 SIRT+CIS GEM participants due to early termination and database errors. The validity and reliability of these data are not complete.
The outcome was not analyzed due to unreliability of the clinical database.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=42 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=36 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Overall Survival
Number of Participants Alive
|
14 Participants
|
12 Participants
|
|
Overall Survival
Number of Participants Expired
|
28 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 18 months following the date of randomization.Population: Data were collected for only 14 unique patients within the study due to early study termination and database issues. Any available data are reflected in the table. The validity and reliability of these data are not complete.
To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin. The outcome was not analyzed due to unreliability of the clinical database.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=7 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=7 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Liver Surgical Resection and Ablation Rate
Count of participants with resection only
|
4 Participants
|
4 Participants
|
|
Liver Surgical Resection and Ablation Rate
Count of participants with resection and ablation
|
1 Participants
|
1 Participants
|
|
Liver Surgical Resection and Ablation Rate
Count of participants with no resection or ablation
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Informed consent until 28 days post last dose of protocol chemotherapy.Population: The following endpoints reflects safety and tolerability data related to Adverse Event grade by category. Counts of participants with Grade 3 or higher adverse event severity by AE category by treatment arm are shown below.
Adverse events (AEs) as assessed by CTCAE v. 4.0. Summaries of non-serious AEs (clinical database, MedDRA 20.1) and serious adverse events (SAEs; pharmacovigilance database, MedDRA 25.1) are provided for information only in the 'Adverse Events' section - the data are deemed unreliable.
Outcome measures
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=48 Participants
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=41 Participants
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Incidence of Adverse Events (Safety and Tolerability)
Serious Adverse Events
|
17 Participants
|
20 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Blood and lymphatic system disorders
|
15 Participants
|
16 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Cardiac disorders
|
2 Participants
|
2 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Gastrointestinal disorders
|
5 Participants
|
5 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher General disorders and administration site conditions
|
5 Participants
|
8 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Hepatobiliary disorders
|
3 Participants
|
4 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Immune system disorders
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Infections and infestations
|
3 Participants
|
0 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Injury, poisoning and procedural complications
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Investigations
|
16 Participants
|
26 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Metabolism and nutrition disorders
|
3 Participants
|
4 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Musculoskeletal and connective tissue disorders
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Nervous system disorders
|
0 Participants
|
3 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Psychiatric disorders
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Renal and urinary disorders
|
2 Participants
|
0 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Reproductive system and breast disorders
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Respiratory, thoracic and mediastinal disorders
|
4 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Skin and subcutaneous tissue disorders
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Surgical and medical procedures
|
0 Participants
|
2 Participants
|
|
Incidence of Adverse Events (Safety and Tolerability)
Grade 3 or higher Vascular disorders
|
4 Participants
|
4 Participants
|
Adverse Events
Chemotherapy (Cisplatin-Gemcitabine)
Serious events: 17 serious events
Other events: 47 other events
Deaths: 28 deaths
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
Serious events: 21 serious events
Other events: 41 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=48 participants at risk
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=41 participants at risk
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
2/48 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
4/48 • Number of events 4 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Cardiac disorders
Cardiac arrest
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Cardiac disorders
Cardiac failure
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
1/48 • Number of events 3 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/48 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Spigelian hernia
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Chills
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Condition aggravated
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Fatigue
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Number of events 5 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Oedema peripheral
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Pyrexia
|
4.2%
2/48 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Strangulated hernia
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Bronchitis
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Infection
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Pneumocytis jirovecii pneumonia
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Injury, poisoning and procedural complications
Post embolization syndrome
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Injury, poisoning and procedural complications
Procedural shock
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Injury, poisoning and procedural complications
Radiation hepatitis
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Gout
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Posterior reversable encephalopathy syndrome
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 2 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Surgical and medical procedures
Drug delivery device placement
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Vascular disorders
Arterial haemorrhage
|
2.1%
1/48 • Number of events 1 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
Other adverse events
| Measure |
Chemotherapy (Cisplatin-Gemcitabine)
n=48 participants at risk
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Cisplatin-gemcitabine: Systemic chemotherapy
|
Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)
n=41 participants at risk
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Cisplatin-gemcitabine: Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
64.6%
31/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
58.5%
24/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
8/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
17.1%
7/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.6%
7/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
19.5%
8/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Cardiac disorders
Palpitations
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Ear and labyrinth disorders
Hypoacusis
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.4%
5/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.8%
10/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
26.8%
11/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.8%
10/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
26.8%
11/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
14.6%
6/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
24/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
43.9%
18/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
15/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
24.4%
10/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
14.6%
6/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
1/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Nausea
|
47.9%
23/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
63.4%
26/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
8/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
22.0%
9/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
12/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
46.3%
19/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Asthenia
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Fatigue
|
70.8%
34/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
78.0%
32/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Influenza like illness
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Oedema peripheral
|
25.0%
12/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
34.1%
14/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Pain
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
General disorders
Pyrexia
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
24.4%
10/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Bronchitis
|
12.5%
6/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Blood alkaline phosphatase increase
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Blood creatine increased
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Neutrophil count decreased
|
35.4%
17/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
63.4%
26/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Platelet count decreased
|
22.9%
11/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
43.9%
18/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
Weight decreased
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Investigations
White blood cell count decreased
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
19.5%
8/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
16/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
58.5%
24/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralagia
|
10.4%
5/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
24.4%
10/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.1%
1/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
8/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
14.6%
6/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Headache
|
10.4%
5/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Lethargy
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Paraesthesia
|
4.2%
2/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.2%
14/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
22.0%
9/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Psychiatric disorders
Anxiety
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
4.9%
2/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
2.4%
1/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Renal and urinary disorders
Renal failure
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
7/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
12.2%
5/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.2%
15/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
36.6%
15/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.4%
5/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
0.00%
0/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.1%
13/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
31.7%
13/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.4%
5/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
4/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
7.3%
3/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Vascular disorders
Embolism
|
6.2%
3/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
9.8%
4/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
|
Vascular disorders
Hypertension
|
14.6%
7/48 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
17.1%
7/41 • Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must provide a proposed publication to Sponsor \>=30 days prior to publication submission for review and comment on the appropriateness of the data analysis and presentation, confidential Information, and rights regarding inventions or other intellectual property. The Sponsor may extend the review period by +30 days. Publication can be delayed by Sponsor to file patent applications but such delay shall not exceed 24 months from the date of such notice to the Investigator.
- Publication restrictions are in place
Restriction type: OTHER