Trial Outcomes & Findings for ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer (NCT NCT01041404)

NCT ID: NCT01041404

Last Updated: 2014-11-05

Results Overview

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

584 participants

Primary outcome timeframe

Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Results posted on

2014-11-05

Participant Flow

Participant milestones

Participant milestones
Measure
Fluoropyrimidine/Cisplatin (FP)
Participants received fluoropyrimidine (EITHER 5-fluorouracil \[5-FU\] or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m\^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Overall Study
STARTED
290
294
Overall Study
Entered Follow-Up
251
251
Overall Study
Died in Follow-up
199
200
Overall Study
Lost to Follow-up
12
10
Overall Study
Alive in Follow-up
40
41
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
290
294

Reasons for withdrawal

Reasons for withdrawal
Measure
Fluoropyrimidine/Cisplatin (FP)
Participants received fluoropyrimidine (EITHER 5-fluorouracil \[5-FU\] or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m\^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Overall Study
Adverse Event
45
35
Overall Study
Lack of Efficacy
200
210
Overall Study
Violation of Selection Criteria
0
1
Overall Study
Protocol Violation
4
0
Overall Study
Withdrawal by Subject
29
23
Overall Study
Failure to Return
1
2
Overall Study
Other
11
23

Baseline Characteristics

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Total
n=584 Participants
Total of all reporting groups
Age, Continuous
58.5 years
STANDARD_DEVIATION 11.22 • n=5 Participants
59.4 years
STANDARD_DEVIATION 10.75 • n=7 Participants
59.0 years
STANDARD_DEVIATION 10.99 • n=5 Participants
Sex: Female, Male
Female
72 Participants
n=5 Participants
68 Participants
n=7 Participants
140 Participants
n=5 Participants
Sex: Female, Male
Male
218 Participants
n=5 Participants
226 Participants
n=7 Participants
444 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Overall Survival (OS) - Percentage of Participants With an Event
62.8 percentage of participants
56.8 percentage of participants

PRIMARY outcome

Timeframe: BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Overall Survival - Time to Event
11.1 months
Interval 10.0 to 13.0
13.8 months
Interval 12.0 to 16.0

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Progression-Free Survival (PFS) - Percentage of Participants With an Event
81.0 percentage of participants
76.9 percentage of participants

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Progression-Free Survival - Time to Event
5.5 months
Interval 5.0 to 6.0
6.7 months
Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Time to Progression (TTP) - Percentage of Participants With an Event
74.1 percentage of participants
70.7 percentage of participants

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Time to Progression - Time to Event
5.6 months
Interval 5.0 to 6.0
7.1 months
Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
34.5 percentage of participants
Interval 29.0 to 40.3
47.3 percentage of participants
Interval 41.5 to 53.2

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS; only participants with a CR or PR were included in the analysis.

Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=100 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=139 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Duration of Response - Percentage of Participants With an Event
80.0 percentage of participants
71.9 percentage of participants

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS; only participants with a CR or PR were included in the analysis.

The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=100 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=139 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Duration of Response
4.8 months
Interval 4.0 to 6.0
6.9 months
Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Percentage of Participants With Clinical Benefit
69.3 percentage of participants
Interval 63.7 to 74.6
78.9 percentage of participants
Interval 73.8 to 83.4

SECONDARY outcome

Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS; n (number) = number of participants assessed for a specific parameter at a given visit.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 118 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
75.0 scores on a scale
Standard Error 3.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 106 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
98.3 scores on a scale
Standard Error 1.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 55 (n=5,24)
76.7 scores on a scale
Standard Error 4.08
73.8 scores on a scale
Standard Error 4.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 85 (n=2,6)
95.8 scores on a scale
Standard Error 4.17
91.7 scores on a scale
Standard Error 5.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 58 (n=5,21)
76.7 scores on a scale
Standard Error 4.08
73.8 scores on a scale
Standard Error 4.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 61 (n=4,17)
79.2 scores on a scale
Standard Error 7.98
72.5 scores on a scale
Standard Error 5.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 64 (n=3,20)
77.8 scores on a scale
Standard Error 5.56
70.0 scores on a scale
Standard Error 4.85
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 67 (n=4,17)
75.0 scores on a scale
Standard Error 4.81
72.5 scores on a scale
Standard Error 5.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 70 (n=3,14)
77.8 scores on a scale
Standard Error 5.56
68.5 scores on a scale
Standard Error 5.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 22 (n=79,143)
14.8 scores on a scale
Standard Error 2.38
17.0 scores on a scale
Standard Error 2.24
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 88 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
90.3 scores on a scale
Standard Error 3.98
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: BL (n=274,287)
55.3 scores on a scale
Standard Error 1.43
54.9 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 4 (n=235,249)
61.0 scores on a scale
Standard Error 1.37
60.9 scores on a scale
Standard Error 1.28
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 7 (n=180,220)
60.9 scores on a scale
Standard Error 1.54
60.5 scores on a scale
Standard Error 1.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 10 (n=176,202)
62.3 scores on a scale
Standard Error 1.58
61.9 scores on a scale
Standard Error 1.42
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 13 (n=152,182)
63.8 scores on a scale
Standard Error 1.77
63.6 scores on a scale
Standard Error 1.47
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 16 (n=121,165)
60.8 scores on a scale
Standard Error 1.85
61.9 scores on a scale
Standard Error 1.58
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 91 (n=2,4)
100.0 scores on a scale
Standard Error 0.00
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 19 (n=114,143)
61.0 scores on a scale
Standard Error 1.94
63.8 scores on a scale
Standard Error 1.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 22 (n=78,143)
65.1 scores on a scale
Standard Error 2.32
64.9 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 25 (n=64,124)
68.0 scores on a scale
Standard Error 2.65
67.8 scores on a scale
Standard Error 2.02
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 73 (n=3,12)
80.6 scores on a scale
Standard Error 2.78
68.1 scores on a scale
Standard Error 5.97
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 25 (n=64,124)
15.1 scores on a scale
Standard Error 3.05
15.9 scores on a scale
Standard Error 2.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 28 (n=47,111)
72.0 scores on a scale
Standard Error 2.69
68.5 scores on a scale
Standard Error 2.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 31 (n=45,95)
69.6 scores on a scale
Standard Error 2.83
70.0 scores on a scale
Standard Error 2.07
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 34 (n=36,87)
70.8 scores on a scale
Standard Error 3.55
72.0 scores on a scale
Standard Error 2.18
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 37 (n=29,64)
66.1 scores on a scale
Standard Error 3.72
70.6 scores on a scale
Standard Error 2.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 40 (n=23,55)
62.0 scores on a scale
Standard Error 4.97
70.6 scores on a scale
Standard Error 2.92
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 43 (n=12,43)
72.9 scores on a scale
Standard Error 5.14
73.6 scores on a scale
Standard Error 3.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 76 (n=3,8)
77.8 scores on a scale
Standard Error 5.56
67.7 scores on a scale
Standard Error 8.97
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 79 (n=3,9)
77.8 scores on a scale
Standard Error 5.56
69.4 scores on a scale
Standard Error 7.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 82 (n=2,5)
83.3 scores on a scale
Standard Error 0.00
60.0 scores on a scale
Standard Error 10.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 85 (n=2,6)
83.3 scores on a scale
Standard Error 0.00
79.2 scores on a scale
Standard Error 6.72
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 88 (n=2,6)
83.3 scores on a scale
Standard Error 0.00
73.6 scores on a scale
Standard Error 5.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 91 (n=2,4)
83.3 scores on a scale
Standard Error 0.00
79.2 scores on a scale
Standard Error 5.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 94 (n=2,6)
83.3 scores on a scale
Standard Error 0.00
79.2 scores on a scale
Standard Error 7.98
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 46 (n=13,42)
75.0 scores on a scale
Standard Error 4.00
73.8 scores on a scale
Standard Error 3.18
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 49 (n=9,36)
68.5 scores on a scale
Standard Error 5.69
76.6 scores on a scale
Standard Error 2.83
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 52 (n=7,29)
72.6 scores on a scale
Standard Error 3.95
71.3 scores on a scale
Standard Error 4.02
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 100 (n=1,4)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
85.4 scores on a scale
Standard Error 5.24
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 103 (n=1,3)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
75.0 scores on a scale
Standard Error 4.81
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 106 (n=1,4)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
77.1 scores on a scale
Standard Error 3.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 97 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
78.3 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 103 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
87.5 scores on a scale
Standard Error 5.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 106 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
89.6 scores on a scale
Standard Error 3.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 109 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
91.7 scores on a scale
Standard Error 4.81
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 112 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.0 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 115 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
93.8 scores on a scale
Standard Error 3.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 118 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 4.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 121 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.0 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 124 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 127 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
88.9 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 133 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
91.7 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Final Visit (n=158,161)
75.1 scores on a scale
Standard Error 2.16
74.3 scores on a scale
Standard Error 2.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: BL (n=276,287)
86.9 scores on a scale
Standard Error 1.06
85.7 scores on a scale
Standard Error 1.20
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 109 (n=1,4)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
77.1 scores on a scale
Standard Error 3.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 4 (n=235,250)
86.0 scores on a scale
Standard Error 1.14
86.3 scores on a scale
Standard Error 1.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 112 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
75.0 scores on a scale
Standard Error 3.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 115 (n=1,4)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
72.9 scores on a scale
Standard Error 3.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 121 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
75.0 scores on a scale
Standard Error 3.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 7 (n=180,220)
85.7 scores on a scale
Standard Error 1.36
86.5 scores on a scale
Standard Error 1.24
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 10 (n=176,202)
85.6 scores on a scale
Standard Error 1.35
86.8 scores on a scale
Standard Error 1.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 13 (n=152,183)
88.2 scores on a scale
Standard Error 1.34
85.7 scores on a scale
Standard Error 1.43
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 124 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
81.7 scores on a scale
Standard Error 5.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 16 (n=121,165)
82.8 scores on a scale
Standard Error 1.70
86.8 scores on a scale
Standard Error 1.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 19 (n=114,143)
84.2 scores on a scale
Standard Error 1.62
87.6 scores on a scale
Standard Error 1.40
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 127 (n=1,3)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
72.2 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
72.2 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 133 (n=1,3)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
72.2 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
66.7 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
66.7 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
66.7 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
66.7 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Global Health Status: Final Visit (n=158,160)
53.2 scores on a scale
Standard Error 2.09
53.1 scores on a scale
Standard Error 2.20
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: BL (n=276,287)
78.9 scores on a scale
Standard Error 1.16
79.6 scores on a scale
Standard Error 1.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 4 (n=235,250)
76.0 scores on a scale
Standard Error 1.27
79.5 scores on a scale
Standard Error 1.20
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 7 (n=181,220)
79.3 scores on a scale
Standard Error 1.37
79.3 scores on a scale
Standard Error 1.25
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 10 (n=174,201)
78.2 scores on a scale
Standard Error 1.47
80.2 scores on a scale
Standard Error 1.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 73 (n=3,12)
94.4 scores on a scale
Standard Error 5.56
82.9 scores on a scale
Standard Error 5.25
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 76 (n=3,8)
100.0 scores on a scale
Standard Error 0.00
87.5 scores on a scale
Standard Error 6.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 79 (n=3,9)
97.2 scores on a scale
Standard Error 2.78
84.3 scores on a scale
Standard Error 7.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 82 (n=2,6)
95.8 scores on a scale
Standard Error 4.17
83.3 scores on a scale
Standard Error 13.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 13 (n=151,183)
80.2 scores on a scale
Standard Error 1.53
80.5 scores on a scale
Standard Error 1.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 16 (n=121,165)
79.8 scores on a scale
Standard Error 1.58
80.7 scores on a scale
Standard Error 1.37
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 19 (n=114,143)
78.8 scores on a scale
Standard Error 1.81
81.5 scores on a scale
Standard Error 1.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 22 (n=79,143)
80.7 scores on a scale
Standard Error 2.20
83.6 scores on a scale
Standard Error 1.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 25 (n=64,124)
85.8 scores on a scale
Standard Error 2.07
84.8 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 28 (n=47,110)
86.2 scores on a scale
Standard Error 2.50
83.7 scores on a scale
Standard Error 1.60
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 31 (n=45,95)
85.6 scores on a scale
Standard Error 2.45
85.4 scores on a scale
Standard Error 1.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 34 (n=37,87)
86.3 scores on a scale
Standard Error 2.50
85.1 scores on a scale
Standard Error 1.89
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 37 (n=29,64)
85.7 scores on a scale
Standard Error 3.43
85.8 scores on a scale
Standard Error 2.05
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 40 (n=24,55)
84.4 scores on a scale
Standard Error 3.51
88.2 scores on a scale
Standard Error 1.88
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 43 (n=12,43)
85.6 scores on a scale
Standard Error 3.75
89.9 scores on a scale
Standard Error 1.85
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 46 (n=14,42)
87.6 scores on a scale
Standard Error 3.03
91.9 scores on a scale
Standard Error 1.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 49 (n=10,36)
88.7 scores on a scale
Standard Error 3.45
92.0 scores on a scale
Standard Error 1.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 52 (n=8,30)
88.3 scores on a scale
Standard Error 3.93
89.2 scores on a scale
Standard Error 2.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 55 (n=6,24)
85.6 scores on a scale
Standard Error 5.28
93.1 scores on a scale
Standard Error 1.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 58 (n=6,21)
86.7 scores on a scale
Standard Error 5.71
91.4 scores on a scale
Standard Error 2.88
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 61 (n=4,17)
91.7 scores on a scale
Standard Error 5.00
91.0 scores on a scale
Standard Error 3.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 79 (n=3,9)
100.0 scores on a scale
Standard Error 0.00
81.5 scores on a scale
Standard Error 7.58
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 64 (n=3,20)
95.6 scores on a scale
Standard Error 4.44
91.0 scores on a scale
Standard Error 3.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 112 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
93.3 scores on a scale
Standard Error 4.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 67 (n=4,17)
93.3 scores on a scale
Standard Error 4.71
93.3 scores on a scale
Standard Error 2.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 70 (n=3,14)
97.8 scores on a scale
Standard Error 2.22
92.9 scores on a scale
Standard Error 3.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 73 (n=3,12)
97.8 scores on a scale
Standard Error 2.22
91.1 scores on a scale
Standard Error 3.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 76 (n=3,8)
95.6 scores on a scale
Standard Error 4.44
90.0 scores on a scale
Standard Error 5.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 79 (n=3,9)
95.6 scores on a scale
Standard Error 4.44
92.6 scores on a scale
Standard Error 3.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 82 (n=2,6)
93.3 scores on a scale
Standard Error 6.67
90.0 scores on a scale
Standard Error 6.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 85 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
95.6 scores on a scale
Standard Error 2.81
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 88 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
95.6 scores on a scale
Standard Error 2.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 91 (n=2,4)
100.0 scores on a scale
Standard Error 0.00
98.3 scores on a scale
Standard Error 1.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 94 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
97.8 scores on a scale
Standard Error 2.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 97 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
97.3 scores on a scale
Standard Error 2.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 100 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 103 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 28 (n=47,110)
9.9 scores on a scale
Standard Error 3.03
13.3 scores on a scale
Standard Error 2.07
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 109 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.0 scores on a scale
Standard Error 3.19
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 112 (n=1,5)
93.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
97.3 scores on a scale
Standard Error 2.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 115 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
93.3 scores on a scale
Standard Error 4.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 118 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.0 scores on a scale
Standard Error 4.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 121 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
94.7 scores on a scale
Standard Error 3.89
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 124 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.0 scores on a scale
Standard Error 2.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 127 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
93.3 scores on a scale
Standard Error 3.85
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
93.3 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 133 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.6 scores on a scale
Standard Error 4.44
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
93.3 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
93.3 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
93.3 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Physical Functioning: Final Visit (n=158,161)
72.1 scores on a scale
Standard Error 1.97
73.8 scores on a scale
Standard Error 2.19
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: BL (n=276,287)
73.2 scores on a scale
Standard Error 1.70
73.9 scores on a scale
Standard Error 1.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 4 (n=234,250)
67.4 scores on a scale
Standard Error 1.85
76.1 scores on a scale
Standard Error 1.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 7 (n=181,220)
70.9 scores on a scale
Standard Error 1.99
73.3 scores on a scale
Standard Error 1.85
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 10 (n=176,202)
70.2 scores on a scale
Standard Error 2.06
74.3 scores on a scale
Standard Error 1.87
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 13 (n=152,182)
73.4 scores on a scale
Standard Error 2.11
75.1 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 16 (n=121,165)
72.0 scores on a scale
Standard Error 2.41
74.6 scores on a scale
Standard Error 1.98
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 19 (n=114,143)
71.1 scores on a scale
Standard Error 2.21
75.8 scores on a scale
Standard Error 2.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 22 (n=79,142)
74.7 scores on a scale
Standard Error 2.81
79.7 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 25 (n=64,124)
81.3 scores on a scale
Standard Error 2.93
82.4 scores on a scale
Standard Error 1.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 28 (n=47,110)
80.5 scores on a scale
Standard Error 3.52
79.7 scores on a scale
Standard Error 2.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 31 (n=45,95)
82.2 scores on a scale
Standard Error 2.87
81.1 scores on a scale
Standard Error 2.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 34 (n=37,87)
83.3 scores on a scale
Standard Error 3.10
82.2 scores on a scale
Standard Error 2.64
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 37 (n=29,64)
81.6 scores on a scale
Standard Error 4.16
81.5 scores on a scale
Standard Error 2.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 40 (n=24,55)
79.9 scores on a scale
Standard Error 4.91
82.1 scores on a scale
Standard Error 3.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 43 (n=12,43)
80.6 scores on a scale
Standard Error 4.95
86.8 scores on a scale
Standard Error 2.63
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 46 (n=14,42)
82.1 scores on a scale
Standard Error 4.44
86.5 scores on a scale
Standard Error 2.74
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 49 (n=10,36)
81.7 scores on a scale
Standard Error 6.78
88.0 scores on a scale
Standard Error 2.94
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 52 (n=8,30)
85.4 scores on a scale
Standard Error 5.84
84.4 scores on a scale
Standard Error 3.57
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 55 (n=6,24)
80.6 scores on a scale
Standard Error 5.12
88.2 scores on a scale
Standard Error 3.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 58 (n=6,21)
77.8 scores on a scale
Standard Error 5.56
89.7 scores on a scale
Standard Error 3.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 61 (n=4,17)
83.3 scores on a scale
Standard Error 9.62
87.3 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 64 (n=3,20)
83.3 scores on a scale
Standard Error 9.62
87.5 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 67 (n=4,17)
83.3 scores on a scale
Standard Error 6.80
90.2 scores on a scale
Standard Error 3.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 70 (n=3,14)
88.9 scores on a scale
Standard Error 5.56
86.9 scores on a scale
Standard Error 5.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 73 (n=3,12)
88.9 scores on a scale
Standard Error 5.56
80.6 scores on a scale
Standard Error 5.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 76 (n=3,8)
83.3 scores on a scale
Standard Error 9.62
81.3 scores on a scale
Standard Error 7.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 79 (n=3,9)
83.3 scores on a scale
Standard Error 9.62
81.5 scores on a scale
Standard Error 7.58
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 82 (n=2,6)
91.7 scores on a scale
Standard Error 8.33
80.6 scores on a scale
Standard Error 10.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 85 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
91.7 scores on a scale
Standard Error 5.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 88 (n=2,6)
91.7 scores on a scale
Standard Error 8.33
94.4 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 91 (n=2,4)
91.7 scores on a scale
Standard Error 8.33
91.7 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 94 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 97 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 100 (n=1,4)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 103 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 106 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 109 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 112 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
93.3 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 115 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
83.3 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 118 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
86.7 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 121 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 124 (n=1,5)
83.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 127 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
88.9 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
88.9 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 133 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
88.9 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
83.3 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
83.3 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
83.3 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Role Functioning: Final Visit (n=158,161)
63.5 scores on a scale
Standard Error 2.46
68.7 scores on a scale
Standard Error 2.51
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: BL (n=276,287)
75.4 scores on a scale
Standard Error 1.26
73.1 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 4 (n=235,250)
80.5 scores on a scale
Standard Error 1.25
77.9 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 7 (n=180,220)
81.3 scores on a scale
Standard Error 1.39
80.2 scores on a scale
Standard Error 1.37
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 10 (n=176,202)
82.9 scores on a scale
Standard Error 1.39
81.2 scores on a scale
Standard Error 1.31
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 13 (n=152,183)
82.6 scores on a scale
Standard Error 1.48
80.5 scores on a scale
Standard Error 1.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 16 (n=121,165)
83.1 scores on a scale
Standard Error 1.81
81.9 scores on a scale
Standard Error 1.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 19 (n=114,143)
82.2 scores on a scale
Standard Error 1.95
82.4 scores on a scale
Standard Error 1.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 22 (n=79,143)
85.9 scores on a scale
Standard Error 2.06
84.0 scores on a scale
Standard Error 1.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 25 (n=64,124)
88.2 scores on a scale
Standard Error 1.97
84.8 scores on a scale
Standard Error 1.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 28 (n=47,111)
86.0 scores on a scale
Standard Error 2.37
85.5 scores on a scale
Standard Error 1.54
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 31 (n=45,95)
85.7 scores on a scale
Standard Error 2.24
85.7 scores on a scale
Standard Error 1.78
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 34 (n=37,87)
88.5 scores on a scale
Standard Error 2.29
85.4 scores on a scale
Standard Error 1.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 37 (n=29,64)
83.9 scores on a scale
Standard Error 3.43
86.3 scores on a scale
Standard Error 2.12
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 40 (n=24,55)
83.6 scores on a scale
Standard Error 3.99
86.7 scores on a scale
Standard Error 2.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 43 (n=12,43)
81.9 scores on a scale
Standard Error 5.21
87.8 scores on a scale
Standard Error 2.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 46 (n=14,42)
82.1 scores on a scale
Standard Error 4.44
87.5 scores on a scale
Standard Error 2.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 49 (n=10,36)
88.3 scores on a scale
Standard Error 4.16
91.4 scores on a scale
Standard Error 2.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 52 (n=8,29)
86.5 scores on a scale
Standard Error 5.88
88.2 scores on a scale
Standard Error 3.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 55 (n=6,24)
76.4 scores on a scale
Standard Error 9.23
88.5 scores on a scale
Standard Error 2.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 58 (n=6,21)
85.6 scores on a scale
Standard Error 6.27
88.9 scores on a scale
Standard Error 3.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 61 (n=4,17)
95.8 scores on a scale
Standard Error 2.41
90.7 scores on a scale
Standard Error 2.25
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 64 (n=3,20)
100 scores on a scale
Standard Error 0.00
86.3 scores on a scale
Standard Error 3.59
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 67 (n=4,17)
95.8 scores on a scale
Standard Error 2.41
89.2 scores on a scale
Standard Error 3.26
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 70 (n=3,14)
97.2 scores on a scale
Standard Error 2.78
89.3 scores on a scale
Standard Error 4.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 22 (n=79,143)
85.9 scores on a scale
Standard Error 1.92
87.4 scores on a scale
Standard Error 1.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 25 (n=64,124)
85.9 scores on a scale
Standard Error 2.20
87.4 scores on a scale
Standard Error 1.50
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 94 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
88.9 scores on a scale
Standard Error 5.12
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 97 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
91.7 scores on a scale
Standard Error 5.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 28 (n=47,111)
86.5 scores on a scale
Standard Error 2.25
88.0 scores on a scale
Standard Error 1.54
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 31 (n=45,95)
87.0 scores on a scale
Standard Error 2.18
90.0 scores on a scale
Standard Error 1.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Emotional Functioning: Week 100 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
87.5 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 37 (n=29,64)
88.5 scores on a scale
Standard Error 2.63
91.4 scores on a scale
Standard Error 1.89
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 40 (n=24,55)
83.3 scores on a scale
Standard Error 3.48
91.5 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 43 (n=12,43)
88.9 scores on a scale
Standard Error 3.75
91.5 scores on a scale
Standard Error 2.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 46 (n=14,42)
89.3 scores on a scale
Standard Error 3.75
91.7 scores on a scale
Standard Error 2.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 49 (n=10,36)
85.0 scores on a scale
Standard Error 5.80
92.6 scores on a scale
Standard Error 2.43
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 34 (n=37,87)
88.3 scores on a scale
Standard Error 2.49
88.7 scores on a scale
Standard Error 1.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 52 (n=8,29)
91.7 scores on a scale
Standard Error 5.46
89.7 scores on a scale
Standard Error 3.35
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 55 (n=6,24)
94.4 scores on a scale
Standard Error 5.56
91.0 scores on a scale
Standard Error 2.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 58 (n=6,21)
91.7 scores on a scale
Standard Error 5.69
90.5 scores on a scale
Standard Error 3.37
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 61 (n=4,17)
91.7 scores on a scale
Standard Error 8.33
91.2 scores on a scale
Standard Error 3.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 82 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
88.9 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 64 (n=3,20)
100.0 scores on a scale
Standard Error 0.00
93.3 scores on a scale
Standard Error 3.29
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 67 (n=4,17)
91.7 scores on a scale
Standard Error 8.33
91.2 scores on a scale
Standard Error 4.07
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 115 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 85 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
91.7 scores on a scale
Standard Error 5.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 88 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
94.4 scores on a scale
Standard Error 3.51
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 91 (n=2,4)
100.0 scores on a scale
Standard Error 0.00
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 94 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
94.4 scores on a scale
Standard Error 3.51
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 118 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 121 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 124 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 127 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 31 (n=45,94)
10.4 scores on a scale
Standard Error 2.77
14.9 scores on a scale
Standard Error 2.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
88.9 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 133 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
94.4 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Final Visit (n=158,161)
79.5 scores on a scale
Standard Error 1.82
80.0 scores on a scale
Standard Error 2.05
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: BL (n=276,286)
72.4 scores on a scale
Standard Error 1.63
72.0 scores on a scale
Standard Error 1.77
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 4 (n=235,250)
72.1 scores on a scale
Standard Error 1.66
74.1 scores on a scale
Standard Error 1.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 7 (n=179,220)
73.1 scores on a scale
Standard Error 1.88
75.1 scores on a scale
Standard Error 1.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 10 (n=176,202)
74.5 scores on a scale
Standard Error 1.84
76.7 scores on a scale
Standard Error 1.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 13 (n=152,183)
72.7 scores on a scale
Standard Error 2.11
76.3 scores on a scale
Standard Error 1.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 16 (n=180,165)
72.7 scores on a scale
Standard Error 2.52
77.5 scores on a scale
Standard Error 1.88
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 19 (n=114,143)
74.4 scores on a scale
Standard Error 2.41
79.5 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 22 (n=79,143)
79.3 scores on a scale
Standard Error 2.77
80.1 scores on a scale
Standard Error 2.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 25 (n=64,124)
83.3 scores on a scale
Standard Error 2.43
80.2 scores on a scale
Standard Error 1.78
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 28 (n=47,111)
83.0 scores on a scale
Standard Error 3.38
80.2 scores on a scale
Standard Error 2.05
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 31 (n=45,95)
81.5 scores on a scale
Standard Error 3.90
78.9 scores on a scale
Standard Error 2.42
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 34 (n=37,87)
84.7 scores on a scale
Standard Error 3.06
80.7 scores on a scale
Standard Error 2.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 37 (n=29,64)
85.1 scores on a scale
Standard Error 4.48
81.8 scores on a scale
Standard Error 2.59
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 40 (n=24,55)
85.4 scores on a scale
Standard Error 4.05
82.7 scores on a scale
Standard Error 2.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 43 (n=12,43)
87.5 scores on a scale
Standard Error 4.64
84.1 scores on a scale
Standard Error 2.77
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 46 (n=14,42)
86.9 scores on a scale
Standard Error 4.34
86.9 scores on a scale
Standard Error 2.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 49 (n=10,36)
85.0 scores on a scale
Standard Error 5.24
84.7 scores on a scale
Standard Error 3.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 52 (n=8,29)
87.5 scores on a scale
Standard Error 6.10
82.2 scores on a scale
Standard Error 3.87
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 55 (n=6,24)
86.1 scores on a scale
Standard Error 6.69
85.4 scores on a scale
Standard Error 3.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 58 (n=6,21)
88.9 scores on a scale
Standard Error 5.56
87.3 scores on a scale
Standard Error 4.13
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 61 (n=4,17)
91.7 scores on a scale
Standard Error 4.81
90.2 scores on a scale
Standard Error 3.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 64 (n=3,20)
94.4 scores on a scale
Standard Error 5.56
85.8 scores on a scale
Standard Error 3.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 67 (n=4,17)
95.8 scores on a scale
Standard Error 4.17
85.3 scores on a scale
Standard Error 4.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 70 (n=3,14)
94.4 scores on a scale
Standard Error 5.56
86.9 scores on a scale
Standard Error 4.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 73 (n=3,12)
100.0 scores on a scale
Standard Error 0.00
80.6 scores on a scale
Standard Error 5.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 76 (n=3,8)
94.4 scores on a scale
Standard Error 5.56
81.3 scores on a scale
Standard Error 7.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 79 (n=3,9)
94.4 scores on a scale
Standard Error 5.56
85.2 scores on a scale
Standard Error 7.58
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Wek 82 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
80.6 scores on a scale
Standard Error 6.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 85 (n=2,6)
91.7 scores on a scale
Standard Error 8.33
88.9 scores on a scale
Standard Error 7.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 88 (n=2,6)
91.7 scores on a scale
Standard Error 8.33
88.9 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 91 (n=2,4)
100.0 scores on a scale
Standard Error 0.00
91.7 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 94 (n=2,6)
100.0 scores on a scale
Standard Error 0.00
91.7 scores on a scale
Standard Error 5.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 97 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 100 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 103 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 106 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
91.7 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 109 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 112 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 115 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 118 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 121 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 124 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
96.7 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 127 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
83.3 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
94.4 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 133 (n=1,3)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Social Functioning: Final Visit (n=158,161)
68.1 scores on a scale
Standard Error 2.41
71.4 scores on a scale
Standard Error 2.39
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: BL (n=276,287)
36.3 scores on a scale
Standard Error 1.37
34.2 scores on a scale
Standard Error 1.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 4 (n=235,250)
37.1 scores on a scale
Standard Error 1.47
34.5 scores on a scale
Standard Error 1.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 7 (n=181,220)
34.4 scores on a scale
Standard Error 1.54
34.1 scores on a scale
Standard Error 1.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 10 (n=176,201)
35.3 scores on a scale
Standard Error 1.70
33.2 scores on a scale
Standard Error 1.50
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 13 (n=152,183)
32.9 scores on a scale
Standard Error 1.70
33.7 scores on a scale
Standard Error 1.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 16 (n=121,165)
33.0 scores on a scale
Standard Error 2.09
32.8 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 19 (n=114,143)
33.1 scores on a scale
Standard Error 2.11
29.4 scores on a scale
Standard Error 1.87
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 22 (n=79,143)
30.0 scores on a scale
Standard Error 2.63
26.7 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 25 (n=64,124)
22.2 scores on a scale
Standard Error 2.55
25.1 scores on a scale
Standard Error 1.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 28 (n=47,110)
24.1 scores on a scale
Standard Error 3.16
23.2 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 31 (n=45,95)
22.0 scores on a scale
Standard Error 2.92
22.2 scores on a scale
Standard Error 2.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 34 (n=37,87)
22.8 scores on a scale
Standard Error 3.63
19.7 scores on a scale
Standard Error 2.28
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 37 (n=29,64)
21.8 scores on a scale
Standard Error 4.63
19.8 scores on a scale
Standard Error 2.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 40 (n=24,55)
23.6 scores on a scale
Standard Error 4.45
18.6 scores on a scale
Standard Error 2.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 43 (n=12,43)
19.4 scores on a scale
Standard Error 3.90
17.1 scores on a scale
Standard Error 2.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 46 (n=14,42)
20.6 scores on a scale
Standard Error 4.18
13.8 scores on a scale
Standard Error 2.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 49 (n=10,36)
19.4 scores on a scale
Standard Error 3.23
14.5 scores on a scale
Standard Error 2.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 52 (n=8,30)
16.7 scores on a scale
Standard Error 2.97
17.2 scores on a scale
Standard Error 3.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 55 (n=6,24)
18.5 scores on a scale
Standard Error 5.49
14.4 scores on a scale
Standard Error 3.75
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 58 (n=6,21)
16.7 scores on a scale
Standard Error 4.76
16.4 scores on a scale
Standard Error 3.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 5.32
14.4 scores on a scale
Standard Error 3.53
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 64 (n=3,20)
7.4 scores on a scale
Standard Error 3.70
17.2 scores on a scale
Standard Error 4.15
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 67 (n=4,17)
13.9 scores on a scale
Standard Error 2.78
15.0 scores on a scale
Standard Error 4.04
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 70 (n=3,14)
11.1 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 5.04
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 73 (n=3,12)
7.4 scores on a scale
Standard Error 3.70
16.7 scores on a scale
Standard Error 5.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 76 (n=3,8)
7.4 scores on a scale
Standard Error 3.70
18.1 scores on a scale
Standard Error 6.94
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 79 (n=3,9)
7.4 scores on a scale
Standard Error 3.70
18.5 scores on a scale
Standard Error 7.64
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
29.6 scores on a scale
Standard Error 8.92
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 85 (n=2,6)
5.6 scores on a scale
Standard Error 5.56
11.1 scores on a scale
Standard Error 5.74
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
9.3 scores on a scale
Standard Error 3.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 7.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
7.4 scores on a scale
Standard Error 5.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 97 (n=1,5)
11.1 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 6.09
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 7.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
19.4 scores on a scale
Standard Error 5.32
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 106 (n=1,4)
11.1 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.9 scores on a scale
Standard Error 6.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 7.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
17.8 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
25.0 scores on a scale
Standard Error 5.32
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
17.8 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
17.8 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 6.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
14.8 scores on a scale
Standard Error 9.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
18.5 scores on a scale
Standard Error 7.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
14.8 scores on a scale
Standard Error 9.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
22.2 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
22.2 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
22.2 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
11.1 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Fatigue: Final Visit (n=158,160)
40.4 scores on a scale
Standard Error 2.17
37.6 scores on a scale
Standard Error 2.31
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: BL (n=276,287)
15.0 scores on a scale
Standard Error 1.39
15.7 scores on a scale
Standard Error 1.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 4 (n=235,250)
16.6 scores on a scale
Standard Error 1.45
19.7 scores on a scale
Standard Error 1.46
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 7 (n=181,220)
16.9 scores on a scale
Standard Error 1.66
18.9 scores on a scale
Standard Error 1.63
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 10 (n=176,201)
16.4 scores on a scale
Standard Error 1.67
16.4 scores on a scale
Standard Error 1.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 13 (n=121,183)
12.8 scores on a scale
Standard Error 1.41
14.7 scores on a scale
Standard Error 1.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 16 (n=121,165)
14.2 scores on a scale
Standard Error 1.99
14.5 scores on a scale
Standard Error 1.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 19 (n=114,143)
14.2 scores on a scale
Standard Error 2.01
13.9 scores on a scale
Standard Error 1.59
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 22 (n=79,143)
10.3 scores on a scale
Standard Error 2.23
12.2 scores on a scale
Standard Error 1.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 25 (n=64,124)
8.6 scores on a scale
Standard Error 2.38
8.2 scores on a scale
Standard Error 1.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 28 (n=47,110)
3.5 scores on a scale
Standard Error 1.34
6.5 scores on a scale
Standard Error 1.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 31 (n=45,95)
3.7 scores on a scale
Standard Error 1.58
8.8 scores on a scale
Standard Error 2.02
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 34 (n=37,87)
4.5 scores on a scale
Standard Error 1.90
7.5 scores on a scale
Standard Error 1.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 37 (n=29,64)
2.9 scores on a scale
Standard Error 1.67
6.8 scores on a scale
Standard Error 2.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 40 (n=24,55)
4.2 scores on a scale
Standard Error 1.50
4.8 scores on a scale
Standard Error 1.87
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 43 (n=12,43)
2.8 scores on a scale
Standard Error 1.87
1.2 scores on a scale
Standard Error 0.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 46 (n=14,42)
1.2 scores on a scale
Standard Error 1.19
2.8 scores on a scale
Standard Error 1.12
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 49 (n=10,36)
3.3 scores on a scale
Standard Error 2.22
0.9 scores on a scale
Standard Error 0.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 52 (n=8,30)
2.1 scores on a scale
Standard Error 2.08
5.0 scores on a scale
Standard Error 2.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 55 (n=6,24)
0.0 scores on a scale
Standard Error 0.00
2.1 scores on a scale
Standard Error 1.15
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 58 (n=6,21)
0.0 scores on a scale
Standard Error 0.00
3.2 scores on a scale
Standard Error 2.19
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 61 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
4.2 scores on a scale
Standard Error 2.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 67 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
2.9 scores on a scale
Standard Error 2.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
2.4 scores on a scale
Standard Error 2.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
1.4 scores on a scale
Standard Error 1.39
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 76 (n=3,8)
5.6 scores on a scale
Standard Error 5.56
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Nausea & Vomiting: Final Visit (n=158,161)
14.9 scores on a scale
Standard Error 1.79
19.8 scores on a scale
Standard Error 2.36
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: BL (n=276,287)
24.9 scores on a scale
Standard Error 1.46
25.1 scores on a scale
Standard Error 1.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 4 (n=235,250)
17.8 scores on a scale
Standard Error 1.43
17.9 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 7 (n=181,220)
14.5 scores on a scale
Standard Error 1.43
16.1 scores on a scale
Standard Error 1.50
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 10 (n=176,202)
13.4 scores on a scale
Standard Error 1.34
14.4 scores on a scale
Standard Error 1.42
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 13 (n=152,183)
12.0 scores on a scale
Standard Error 1.42
13.3 scores on a scale
Standard Error 1.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 16 (n=121,165)
13.6 scores on a scale
Standard Error 1.80
12.4 scores on a scale
Standard Error 1.54
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 19 (n=114,143)
14.2 scores on a scale
Standard Error 1.98
12.8 scores on a scale
Standard Error 1.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 22 (n=79,143)
15.0 scores on a scale
Standard Error 2.59
13.2 scores on a scale
Standard Error 1.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 25 (n=64,124)
10.7 scores on a scale
Standard Error 2.44
12.2 scores on a scale
Standard Error 1.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 28 (n=47,111)
8.2 scores on a scale
Standard Error 1.82
12.0 scores on a scale
Standard Error 1.97
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 31 (n=45,95)
12.2 scores on a scale
Standard Error 2.97
11.8 scores on a scale
Standard Error 2.22
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 34 (n=37,87)
12.2 scores on a scale
Standard Error 3.00
11.3 scores on a scale
Standard Error 2.32
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 37 (n=29,64)
11.5 scores on a scale
Standard Error 2.99
12.2 scores on a scale
Standard Error 2.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 40 (n=24,55)
18.8 scores on a scale
Standard Error 4.74
10.3 scores on a scale
Standard Error 2.75
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 43 (n=12,43)
16.7 scores on a scale
Standard Error 5.03
8.9 scores on a scale
Standard Error 2.44
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 46 (n=14,42)
13.1 scores on a scale
Standard Error 3.57
6.7 scores on a scale
Standard Error 2.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 49 (n=10,36)
13.3 scores on a scale
Standard Error 4.84
6.5 scores on a scale
Standard Error 2.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 52 (n=8,30)
6.3 scores on a scale
Standard Error 3.05
10.0 scores on a scale
Standard Error 4.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 55 (n=6,24)
2.8 scores on a scale
Standard Error 2.78
8.3 scores on a scale
Standard Error 4.01
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 58 (n=6,21)
8.3 scores on a scale
Standard Error 5.69
7.1 scores on a scale
Standard Error 3.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 61 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
4.9 scores on a scale
Standard Error 3.43
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 64 (n=3,20)
5.6 scores on a scale
Standard Error 5.56
6.7 scores on a scale
Standard Error 3.06
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 67 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
4.9 scores on a scale
Standard Error 2.77
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
4.8 scores on a scale
Standard Error 4.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 73 (n=3,12)
5.6 scores on a scale
Standard Error 5.56
9.7 scores on a scale
Standard Error 5.97
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 76 (n=3,8)
5.6 scores on a scale
Standard Error 5.56
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 79 (n=3,9)
5.6 scores on a scale
Standard Error 5.56
9.3 scores on a scale
Standard Error 7.41
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
2.8 scores on a scale
Standard Error 2.78
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
2.8 scores on a scale
Standard Error 2.78
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
4.2 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.3 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.3 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.3 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.3 scores on a scale
Standard Error 3.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Pain: Final Visit (n=158,161)
27.4 scores on a scale
Standard Error 2.34
25.4 scores on a scale
Standard Error 2.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: BL (n=274,281)
12.4 scores on a scale
Standard Error 1.25
13.4 scores on a scale
Standard Error 1.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 4 (n=232,249)
12.1 scores on a scale
Standard Error 1.35
11.8 scores on a scale
Standard Error 1.24
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 7 (n=181,217)
12.7 scores on a scale
Standard Error 1.66
10.8 scores on a scale
Standard Error 1.21
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 10 (n=176,198)
14.6 scores on a scale
Standard Error 1.71
11.3 scores on a scale
Standard Error 1.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 13 (n=151,182)
11.3 scores on a scale
Standard Error 1.80
13.7 scores on a scale
Standard Error 1.74
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 16 (n=121,165)
15.4 scores on a scale
Standard Error 2.28
13.5 scores on a scale
Standard Error 1.79
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 19 (n=113,143)
15.3 scores on a scale
Standard Error 2.48
11.9 scores on a scale
Standard Error 1.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 22 (n=79,143)
13.9 scores on a scale
Standard Error 2.79
12.1 scores on a scale
Standard Error 1.64
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 25 (n=63,124)
12.7 scores on a scale
Standard Error 2.76
9.4 scores on a scale
Standard Error 1.60
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 28 (n=47,110)
9.2 scores on a scale
Standard Error 2.42
10.3 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 31 (n=45,95)
10.4 scores on a scale
Standard Error 2.56
9.1 scores on a scale
Standard Error 1.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 34 (n=36,87)
10.2 scores on a scale
Standard Error 2.92
9.6 scores on a scale
Standard Error 2.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 37 (n=29,64)
10.3 scores on a scale
Standard Error 3.35
10.4 scores on a scale
Standard Error 2.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 40 (n=24,55)
9.7 scores on a scale
Standard Error 3.74
4.8 scores on a scale
Standard Error 1.60
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 43 (n=12,43)
19.4 scores on a scale
Standard Error 7.63
6.2 scores on a scale
Standard Error 2.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 46 (n=14,42)
11.9 scores on a scale
Standard Error 4.43
5.6 scores on a scale
Standard Error 1.94
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 49 (n=10,36)
6.7 scores on a scale
Standard Error 4.44
4.6 scores on a scale
Standard Error 1.95
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 52 (n=8,30)
12.5 scores on a scale
Standard Error 6.10
5.6 scores on a scale
Standard Error 2.31
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 55 (n=6,24)
5.6 scores on a scale
Standard Error 5.56
8.3 scores on a scale
Standard Error 3.01
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 58 (n=6,21)
5.6 scores on a scale
Standard Error 5.56
6.3 scores on a scale
Standard Error 3.72
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 61 (n=4,17)
16.7 scores on a scale
Standard Error 9.62
3.9 scores on a scale
Standard Error 2.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 4.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 67 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
5.9 scores on a scale
Standard Error 4.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
7.1 scores on a scale
Standard Error 5.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 4.35
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 76 (n=3,8)
11.1 scores on a scale
Standard Error 11.11
8.3 scores on a scale
Standard Error 5.46
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
7.4 scores on a scale
Standard Error 4.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 11.39
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 85 (n=180,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 34 (n=37,87)
9.0 scores on a scale
Standard Error 2.78
13.4 scores on a scale
Standard Error 2.07
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
16.7 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
16.7 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
16.7 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
33.3 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Dyspnoea: Final Visit (n=157,160)
20.0 scores on a scale
Standard Error 2.13
18.3 scores on a scale
Standard Error 2.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: BL (n=276,285)
27.2 scores on a scale
Standard Error 1.86
23.6 scores on a scale
Standard Error 1.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 4 (n=234,248)
22.1 scores on a scale
Standard Error 1.82
23.3 scores on a scale
Standard Error 1.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 7 (n=181,219)
21.9 scores on a scale
Standard Error 2.10
20.4 scores on a scale
Standard Error 1.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 10 (n=175,200)
19.8 scores on a scale
Standard Error 2.04
18.0 scores on a scale
Standard Error 1.63
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 13 (n=152,183)
14.7 scores on a scale
Standard Error 1.86
18.9 scores on a scale
Standard Error 1.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 16 (n=120,164)
15.3 scores on a scale
Standard Error 1.93
17.7 scores on a scale
Standard Error 1.88
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 19 (n=113,143)
17.1 scores on a scale
Standard Error 2.30
20.0 scores on a scale
Standard Error 2.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 37 (n=29,63)
8.0 scores on a scale
Standard Error 3.16
11.1 scores on a scale
Standard Error 2.26
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 40 (n=24,55)
13.9 scores on a scale
Standard Error 4.45
10.3 scores on a scale
Standard Error 2.58
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 43 (n=12,43)
13.9 scores on a scale
Standard Error 8.66
9.3 scores on a scale
Standard Error 2.79
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 46 (n=13,42)
7.7 scores on a scale
Standard Error 4.05
9.5 scores on a scale
Standard Error 2.85
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 49 (n=10,36)
10.0 scores on a scale
Standard Error 7.11
7.4 scores on a scale
Standard Error 2.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 52 (n=8,30)
12.5 scores on a scale
Standard Error 6.10
7.8 scores on a scale
Standard Error 3.07
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 55 (n=6,24)
16.7 scores on a scale
Standard Error 7.45
8.3 scores on a scale
Standard Error 3.01
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
9.5 scores on a scale
Standard Error 4.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 70 (n=3,14)
100.0 scores on a scale
Standard Error 0.00
91.7 scores on a scale
Standard Error 4.19
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
7.8 scores on a scale
Standard Error 4.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
10.0 scores on a scale
Standard Error 4.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 67 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
9.8 scores on a scale
Standard Error 4.75
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
9.5 scores on a scale
Standard Error 5.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 6.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 5.46
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 7.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 73 (n=3,12)
100.0 scores on a scale
Standard Error 0.00
83.3 scores on a scale
Standard Error 4.59
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Insomnia: Final Visit (n=157,160)
21.9 scores on a scale
Standard Error 2.29
24.6 scores on a scale
Standard Error 2.28
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: BL (n=275,286)
35.2 scores on a scale
Standard Error 2.02
33.8 scores on a scale
Standard Error 2.04
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 4 (n=235,250)
31.5 scores on a scale
Standard Error 2.01
33.6 scores on a scale
Standard Error 2.01
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 7 (n=180,216)
27.2 scores on a scale
Standard Error 2.19
31.3 scores on a scale
Standard Error 2.04
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 10 (n=176,201)
26.7 scores on a scale
Standard Error 2.10
29.4 scores on a scale
Standard Error 2.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 13 (n=151,183)
24.7 scores on a scale
Standard Error 2.11
28.4 scores on a scale
Standard Error 2.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 16 (n=121,165)
24.5 scores on a scale
Standard Error 2.27
27.9 scores on a scale
Standard Error 2.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 19 (n=114,141)
26.9 scores on a scale
Standard Error 2.81
25.1 scores on a scale
Standard Error 2.40
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 22 (n=79,143)
19.0 scores on a scale
Standard Error 2.92
20.7 scores on a scale
Standard Error 2.19
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 25 (n=64,124)
12.0 scores on a scale
Standard Error 2.39
16.7 scores on a scale
Standard Error 1.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 28 (n=47,109)
14.2 scores on a scale
Standard Error 2.82
11.6 scores on a scale
Standard Error 1.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 31 (n=45,95)
11.1 scores on a scale
Standard Error 3.18
13.0 scores on a scale
Standard Error 2.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 34 (n=37,87)
11.7 scores on a scale
Standard Error 2.65
9.6 scores on a scale
Standard Error 2.24
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 37 (n=29,64)
12.6 scores on a scale
Standard Error 3.48
10.9 scores on a scale
Standard Error 2.78
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 40 (n=24,55)
13.9 scores on a scale
Standard Error 3.97
9.7 scores on a scale
Standard Error 2.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 43 (n=12,43)
5.6 scores on a scale
Standard Error 3.75
7.0 scores on a scale
Standard Error 2.37
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 46 (n=14,42)
4.8 scores on a scale
Standard Error 3.24
5.6 scores on a scale
Standard Error 2.25
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 49 (n=9,36)
3.7 scores on a scale
Standard Error 3.70
6.5 scores on a scale
Standard Error 2.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 52 (n=8,30)
0.0 scores on a scale
Standard Error 0.00
10.0 scores on a scale
Standard Error 3.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 55 (n=6,24)
0.0 scores on a scale
Standard Error 0.00
10.0 scores on a scale
Standard Error 3.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 58 (n=6,21)
5.6 scores on a scale
Standard Error 5.56
4.8 scores on a scale
Standard Error 2.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 4.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 67 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
5.9 scores on a scale
Standard Error 3.18
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 76 (n=3,8)
100.0 scores on a scale
Standard Error 0.00
83.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
7.1 scores on a scale
Standard Error 5.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 3.75
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
4.2 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 7.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Appetite Loss: Week Final Visit (n=156,161)
35.3 scores on a scale
Standard Error 2.45
33.5 scores on a scale
Standard Error 2.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: BL (n=276,285)
22.9 scores on a scale
Standard Error 1.79
21.5 scores on a scale
Standard Error 1.69
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 4 (n=235,247)
20.6 scores on a scale
Standard Error 1.85
20.2 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 7 (n=179,220)
19.0 scores on a scale
Standard Error 2.01
17.6 scores on a scale
Standard Error 1.79
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 10 (n=175,203)
19.2 scores on a scale
Standard Error 1.90
15.1 scores on a scale
Standard Error 1.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 13 (n=152,183)
16.7 scores on a scale
Standard Error 1.92
15.8 scores on a scale
Standard Error 1.73
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 16 (n=121,165)
14.6 scores on a scale
Standard Error 1.99
15.4 scores on a scale
Standard Error 1.87
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 19 (n=114,143)
13.5 scores on a scale
Standard Error 2.11
14.5 scores on a scale
Standard Error 1.94
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 22 (n=78,143)
12.0 scores on a scale
Standard Error 2.27
10.0 scores on a scale
Standard Error 1.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 25 (n=64,124)
7.3 scores on a scale
Standard Error 2.40
10.2 scores on a scale
Standard Error 1.71
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 28 (n=47,111)
7.8 scores on a scale
Standard Error 2.31
9.6 scores on a scale
Standard Error 1.93
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 31 (n=45,95)
10.4 scores on a scale
Standard Error 2.96
6.3 scores on a scale
Standard Error 1.68
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 34 (n=37,86)
5.4 scores on a scale
Standard Error 2.05
4.7 scores on a scale
Standard Error 1.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 37 (n=29,64)
11.5 scores on a scale
Standard Error 3.80
10.4 scores on a scale
Standard Error 2.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 40 (n=24,55)
8.3 scores on a scale
Standard Error 3.62
7.9 scores on a scale
Standard Error 2.28
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 43 (n=12,43)
8.3 scores on a scale
Standard Error 4.35
7.0 scores on a scale
Standard Error 2.37
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 46 (n=14,42)
4.8 scores on a scale
Standard Error 3.24
7.1 scores on a scale
Standard Error 2.90
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 49 (n=10,36)
3.3 scores on a scale
Standard Error 3.33
5.6 scores on a scale
Standard Error 2.10
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 52 (n=8,29)
4.2 scores on a scale
Standard Error 4.17
10.3 scores on a scale
Standard Error 4.09
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 55 (n=6,24)
5.6 scores on a scale
Standard Error 5.56
6.9 scores on a scale
Standard Error 4.48
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
6.3 scores on a scale
Standard Error 3.72
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
5.9 scores on a scale
Standard Error 4.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
5.0 scores on a scale
Standard Error 3.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 67 (n=4,17)
0.0 scores on a scale
Standard Error 0.00
5.9 scores on a scale
Standard Error 4.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
4.8 scores on a scale
Standard Error 4.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 6.27
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
4.2 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
3.7 scores on a scale
Standard Error 3.70
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 82 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
16.7 scores on a scale
Standard Error 16.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 85 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Constipation: Final Visit (n=158,160)
19.0 scores on a scale
Standard Error 2.12
20.0 scores on a scale
Standard Error 2.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: BL (n=276,283)
10.9 scores on a scale
Standard Error 1.21
10.7 scores on a scale
Standard Error 1.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 4 (n=234,246)
9.1 scores on a scale
Standard Error 1.25
12.2 scores on a scale
Standard Error 1.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 7 (n=180,220)
8.7 scores on a scale
Standard Error 1.40
14.2 scores on a scale
Standard Error 1.65
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 10 (n=174,202)
10.5 scores on a scale
Standard Error 1.51
11.9 scores on a scale
Standard Error 1.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 13 (n=152,183)
6.6 scores on a scale
Standard Error 1.21
12.0 scores on a scale
Standard Error 1.66
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 16 (n=120,165)
8.1 scores on a scale
Standard Error 1.63
12.9 scores on a scale
Standard Error 1.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 19 (n=114,143)
7.3 scores on a scale
Standard Error 1.70
10.3 scores on a scale
Standard Error 1.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 22 (n=78,143)
6.0 scores on a scale
Standard Error 1.80
9.6 scores on a scale
Standard Error 1.43
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 25 (n=64,124)
7.3 scores on a scale
Standard Error 1.74
6.2 scores on a scale
Standard Error 1.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 28 (n=47,111)
5.7 scores on a scale
Standard Error 1.85
4.8 scores on a scale
Standard Error 1.20
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 31 (n=45,95)
5.9 scores on a scale
Standard Error 1.92
4.9 scores on a scale
Standard Error 1.32
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 34 (n=37,87)
5.4 scores on a scale
Standard Error 2.05
5.7 scores on a scale
Standard Error 1.56
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 37 (n=29,64)
5.7 scores on a scale
Standard Error 2.38
4.2 scores on a scale
Standard Error 1.39
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 40 (n=24,55)
6.9 scores on a scale
Standard Error 2.82
3.0 scores on a scale
Standard Error 1.79
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 43 (n=12,42)
8.3 scores on a scale
Standard Error 4.35
2.4 scores on a scale
Standard Error 1.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 46 (n=14,42)
4.8 scores on a scale
Standard Error 3.24
1.6 scores on a scale
Standard Error 1.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 49 (n=10,36)
10.0 scores on a scale
Standard Error 5.09
3.7 scores on a scale
Standard Error 1.77
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 52 (n=8,29)
8.3 scores on a scale
Standard Error 5.46
2.3 scores on a scale
Standard Error 1.60
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 55 (n=6,24)
11.1 scores on a scale
Standard Error 7.03
4.2 scores on a scale
Standard Error 2.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
4.8 scores on a scale
Standard Error 2.61
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 61 (n=4,17)
16.7 scores on a scale
Standard Error 9.62
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 64 (n=3,20)
11.1 scores on a scale
Standard Error 11.11
3.3 scores on a scale
Standard Error 2.29
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 67 (n=4,17)
16.7 scores on a scale
Standard Error 9.62
2.0 scores on a scale
Standard Error 1.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 70 (n=3,14)
11.1 scores on a scale
Standard Error 11.11
3.3 scores on a scale
Standard Error 2.29
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 73 (n=3,12)
11.1 scores on a scale
Standard Error 11.11
2.0 scores on a scale
Standard Error 1.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 76 (n=3,8)
22.2 scores on a scale
Standard Error 11.11
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 79 (n=3,9)
11.1 scores on a scale
Standard Error 11.11
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 91 (n=2,4)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error 0
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 94 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Diarrhoea: Final Visit (n=157,160)
10.0 scores on a scale
Standard Error 1.55
10.0 scores on a scale
Standard Error 1.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: BL (n=274,286)
27.3 scores on a scale
Standard Error 1.91
29.3 scores on a scale
Standard Error 1.89
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 4 (n=234,249)
23.6 scores on a scale
Standard Error 1.93
27.7 scores on a scale
Standard Error 1.99
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 7 (n=178,220)
23.6 scores on a scale
Standard Error 2.08
23.9 scores on a scale
Standard Error 1.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 10 (n=175,202)
21.5 scores on a scale
Standard Error 2.11
23.3 scores on a scale
Standard Error 2.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 13 (n=151,181)
22.5 scores on a scale
Standard Error 2.23
22.7 scores on a scale
Standard Error 2.08
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 16 (n=120,165)
23.1 scores on a scale
Standard Error 2.58
24.4 scores on a scale
Standard Error 2.26
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 19 (n=113,143)
20.6 scores on a scale
Standard Error 2.53
22.4 scores on a scale
Standard Error 2.49
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 22 (n=78,142)
19.7 scores on a scale
Standard Error 3.01
24.9 scores on a scale
Standard Error 2.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 25 (n=63,124)
16.4 scores on a scale
Standard Error 3.01
22.3 scores on a scale
Standard Error 2.34
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 28 (n=45,111)
17.0 scores on a scale
Standard Error 3.76
21.6 scores on a scale
Standard Error 2.55
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 31 (n=45,94)
15.6 scores on a scale
Standard Error 3.76
23.4 scores on a scale
Standard Error 2.89
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 34 (n=36,87)
10.2 scores on a scale
Standard Error 2.92
24.5 scores on a scale
Standard Error 2.96
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 37 (n=29,64)
13.8 scores on a scale
Standard Error 4.83
23.4 scores on a scale
Standard Error 3.38
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 40 (n=24,55)
22.2 scores on a scale
Standard Error 5.18
23.6 scores on a scale
Standard Error 3.74
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 43 (n=12,43)
16.7 scores on a scale
Standard Error 7.68
19.4 scores on a scale
Standard Error 3.72
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 46 (n=14,42)
16.7 scores on a scale
Standard Error 5.79
18.3 scores on a scale
Standard Error 3.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 49 (n=10,35)
16.7 scores on a scale
Standard Error 5.56
20.0 scores on a scale
Standard Error 4.14
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 52 (n=8,29)
8.3 scores on a scale
Standard Error 5.46
20.7 scores on a scale
Standard Error 4.50
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 55 (n=6,24)
16.7 scores on a scale
Standard Error 11.39
18.1 scores on a scale
Standard Error 5.30
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
22.2 scores on a scale
Standard Error 6.23
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 61 (n=4,17)
16.7 scores on a scale
Standard Error 9.62
23.5 scores on a scale
Standard Error 6.86
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 64 (n=3,20)
11.1 scores on a scale
Standard Error 11.11
16.7 scores on a scale
Standard Error 4.52
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 67 (n=4,17)
16.7 scores on a scale
Standard Error 9.62
17.6 scores on a scale
Standard Error 5.05
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 70 (n=3,14)
11.1 scores on a scale
Standard Error 11.11
19.0 scores on a scale
Standard Error 5.76
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 73 (n=3,12)
11.1 scores on a scale
Standard Error 11.11
19.4 scores on a scale
Standard Error 4.95
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 76 (n=3,8)
11.1 scores on a scale
Standard Error 11.11
25.0 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 79 (n=3,9)
11.1 scores on a scale
Standard Error 11.11
25.9 scores on a scale
Standard Error 10.80
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 82 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
22.2 scores on a scale
Standard Error 7.03
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 85 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
16.7 scores on a scale
Standard Error 7.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 88 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
16.7 scores on a scale
Standard Error 7.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 91 (n=2,4)
16.7 scores on a scale
Standard Error 16.67
25.0 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 94 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
16.7 scores on a scale
Standard Error 7.45
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
20.0 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 8.16
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
11.1 scores on a scale
Standard Error 11.11
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error 0.00
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group at this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Financial Difficulties: Final Visit (n=158,160)
26.6 scores on a scale
Standard Error 2.39
27.9 scores on a scale
Standard Error 2.51
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 97 (n=1,5)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
90.0 scores on a scale
Standard Error 6.67
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 100 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 103 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
91.7 scores on a scale
Standard Error 4.81
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 106 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
Cognitive Functioning: Week 109 (n=1,4)
100.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
95.8 scores on a scale
Standard Error 4.17

SECONDARY outcome

Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS; n = number of participants assessed for a specific parameter at a given visit.

The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 9.62
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 7.45
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Final Visit (n=157,158)
25.3 scores on a scale
Standard Error 2.26
20.3 scores on a scale
Standard Error 2.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: BL (n=272,286)
30.9 scores on a scale
Standard Error 1.95
31.9 scores on a scale
Standard Error 1.93
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 4 (n=233,249)
32.6 scores on a scale
Standard Error 2.10
31.7 scores on a scale
Standard Error 2.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 7 (n=180,219)
30.7 scores on a scale
Standard Error 2.19
27.9 scores on a scale
Standard Error 1.94
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 22 (n=79,143)
28.7 scores on a scale
Standard Error 3.59
22.4 scores on a scale
Standard Error 2.29
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 10 (n=175,203)
30.1 scores on a scale
Standard Error 2.27
28.4 scores on a scale
Standard Error 2.05
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 25 (n=64,124)
22.4 scores on a scale
Standard Error 3.32
22.6 scores on a scale
Standard Error 2.60
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 13 (n=152,182)
28.9 scores on a scale
Standard Error 2.54
28.2 scores on a scale
Standard Error 2.36
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 16 (n=119,165)
29.1 scores on a scale
Standard Error 2.69
28.1 scores on a scale
Standard Error 2.29
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 19 (n=114,140)
30.7 scores on a scale
Standard Error 2.82
25.0 scores on a scale
Standard Error 2.53
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 28 (n=47,111)
23.4 scores on a scale
Standard Error 4.41
20.1 scores on a scale
Standard Error 2.53
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 31 (n=45,95)
25.2 scores on a scale
Standard Error 4.87
19.3 scores on a scale
Standard Error 2.80
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 34 (n=37,87)
18.9 scores on a scale
Standard Error 4.75
18.0 scores on a scale
Standard Error 2.66
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
8.3 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Final Visit (n=157,160)
24.7 scores on a scale
Standard Error 1.60
26.8 scores on a scale
Standard Error 2.02
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: BL (n=275,287)
18.3 scores on a scale
Standard Error 1.29
16.9 scores on a scale
Standard Error 1.12
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 4 (n=234,250)
14.8 scores on a scale
Standard Error 1.14
16.0 scores on a scale
Standard Error 1.09
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 7 (n=180,220)
12.8 scores on a scale
Standard Error 1.26
15.4 scores on a scale
Standard Error 1.20
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 10 (n=176,203)
12.6 scores on a scale
Standard Error 1.29
13.5 scores on a scale
Standard Error 1.18
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 13 (n=152,182)
12.8 scores on a scale
Standard Error 1.39
12.9 scores on a scale
Standard Error 1.34
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 16 (n=120,165)
12.0 scores on a scale
Standard Error 1.55
14.4 scores on a scale
Standard Error 1.58
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 19 (n=114,165)
11.3 scores on a scale
Standard Error 1.76
10.6 scores on a scale
Standard Error 1.24
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 22 (n=79,143)
9.0 scores on a scale
Standard Error 1.79
10.6 scores on a scale
Standard Error 1.37
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 25 (n=64,124)
5.6 scores on a scale
Standard Error 1.21
9.7 scores on a scale
Standard Error 1.34
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 28 (n=47,111)
6.6 scores on a scale
Standard Error 1.61
9.6 scores on a scale
Standard Error 1.42
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 31 (n=45,95)
7.4 scores on a scale
Standard Error 1.69
10.1 scores on a scale
Standard Error 1.93
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 34 (n=45,95)
7.2 scores on a scale
Standard Error 2.16
9.3 scores on a scale
Standard Error 1.77
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 37 (n=29,64)
6.1 scores on a scale
Standard Error 1.62
10.9 scores on a scale
Standard Error 2.38
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 40 (n=24,55)
7.9 scores on a scale
Standard Error 2.80
9.3 scores on a scale
Standard Error 2.13
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 43 (n=12,42)
7.4 scores on a scale
Standard Error 3.44
9.0 scores on a scale
Standard Error 2.07
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 46 (n=14,42)
4.8 scores on a scale
Standard Error 1.53
6.6 scores on a scale
Standard Error 1.97
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 49 (n=10,36)
2.2 scores on a scale
Standard Error 1.48
6.5 scores on a scale
Standard Error 1.43
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 52 (n=8,30)
2.8 scores on a scale
Standard Error 1.82
8.1 scores on a scale
Standard Error 2.55
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 55 (n=6,24)
5.6 scores on a scale
Standard Error 5.56
6.5 scores on a scale
Standard Error 2.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 58 (n=6,21)
0.0 scores on a scale
Standard Error 0.00
5.3 scores on a scale
Standard Error 1.65
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 61 (n=4,17)
2.8 scores on a scale
Standard Error 2.78
2.6 scores on a scale
Standard Error 1.52
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 64 (n=3,20)
3.7 scores on a scale
Standard Error 3.70
3.9 scores on a scale
Standard Error 1.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 67 (n=4,16)
2.8 scores on a scale
Standard Error 2.78
6.3 scores on a scale
Standard Error 2.48
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 70 (n=3,13)
3.7 scores on a scale
Standard Error 3.70
4.3 scores on a scale
Standard Error 2.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
7.9 scores on a scale
Standard Error 2.60
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 76 (n=3,8)
3.7 scores on a scale
Standard Error 3.70
1.4 scores on a scale
Standard Error 1.39
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
3.7 scores on a scale
Standard Error 2.62
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 2.48
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
2.8 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.4 scores on a scale
Standard Error 4.44
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 4.44
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
7.4 scores on a scale
Standard Error 7.41
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Reflux Symptoms Scale: Final Visit (n=1,5)
15.3 scores on a scale
Standard Error 1.48
18.3 scores on a scale
Standard Error 1.72
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Eating Restrictions (ER) Scale: BL (n=276,287)
27.4 scores on a scale
Standard Error 1.44
23.9 scores on a scale
Standard Error 1.30
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 4 (n=234,250)
20.6 scores on a scale
Standard Error 1.24
21.1 scores on a scale
Standard Error 1.19
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 7 (n=181,220)
18.8 scores on a scale
Standard Error 1.36
19.0 scores on a scale
Standard Error 1.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 10 (n=176,203)
17.5 scores on a scale
Standard Error 1.25
17.4 scores on a scale
Standard Error 1.23
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 13 (n=152,183)
16.0 scores on a scale
Standard Error 1.77
17.0 scores on a scale
Standard Error 1.34
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 16 (n=120,165)
17.8 scores on a scale
Standard Error 1.77
15.1 scores on a scale
Standard Error 1.40
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 19 (n=114,143)
20.8 scores on a scale
Standard Error 2.01
15.5 scores on a scale
Standard Error 1.53
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 22 (n=79,143)
15.5 scores on a scale
Standard Error 2.14
13.6 scores on a scale
Standard Error 1.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 25 (n=64,124)
11.6 scores on a scale
Standard Error 2.14
12.9 scores on a scale
Standard Error 1.39
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 28 (n=47,111)
13.9 scores on a scale
Standard Error 2.64
11.3 scores on a scale
Standard Error 1.37
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 31 (n=45,95)
13.4 scores on a scale
Standard Error 2.69
12.5 scores on a scale
Standard Error 2.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 34 (n=37,87)
10.6 scores on a scale
Standard Error 2.16
10.9 scores on a scale
Standard Error 1.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 37 (n=29,64)
12.5 scores on a scale
Standard Error 3.10
9.5 scores on a scale
Standard Error 2.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 40 (n=24,55)
13.5 scores on a scale
Standard Error 3.32
9.5 scores on a scale
Standard Error 2.21
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 43 (n=12,43)
9.7 scores on a scale
Standard Error 3.22
7.0 scores on a scale
Standard Error 1.88
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 46 (n=14,42)
10.9 scores on a scale
Standard Error 3.07
6.0 scores on a scale
Standard Error 1.31
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 49 (n=10,36)
11.7 scores on a scale
Standard Error 3.09
8.1 scores on a scale
Standard Error 1.83
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 52 (n=8,30)
5.2 scores on a scale
Standard Error 2.19
9.3 scores on a scale
Standard Error 2.31
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 55 (n=6,24)
8.3 scores on a scale
Standard Error 4.30
5.2 scores on a scale
Standard Error 1.86
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 58 (n=6,21)
9.7 scores on a scale
Standard Error 5.45
6.0 scores on a scale
Standard Error 2.31
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 61 (n=4,17)
4.2 scores on a scale
Standard Error 2.41
5.4 scores on a scale
Standard Error 2.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
8.3 scores on a scale
Standard Error 2.42
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 67 (n=4,16)
8.3 scores on a scale
Standard Error 4.81
10.4 scores on a scale
Standard Error 3.36
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 70 (n=3,14)
2.8 scores on a scale
Standard Error 2.78
6.5 scores on a scale
Standard Error 2.34
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 73 (n=3,12)
5.6 scores on a scale
Standard Error 5.56
9.0 scores on a scale
Standard Error 3.32
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 76 (n=3,8)
2.8 scores on a scale
Standard Error 2.78
5.2 scores on a scale
Standard Error 3.50
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 79 (n=3,9)
5.6 scores on a scale
Standard Error 5.56
5.6 scores on a scale
Standard Error 3.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 82 (n=2,6)
4.2 scores on a scale
Standard Error 4.17
2.8 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 85 (n=2,6)
4.2 scores on a scale
Standard Error 4.17
4.2 scores on a scale
Standard Error 2.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 88 (n=2,6)
4.2 scores on a scale
Standard Error 4.17
4.2 scores on a scale
Standard Error 1.86
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 91 (n=2,4)
8.3 scores on a scale
Standard Error 8.33
4.2 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
4.2 scores on a scale
Standard Error 2.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: BL (n=276,287)
18.7 scores on a scale
Standard Error 1.27
16.6 scores on a scale
Standard Error 1.21
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 4 (n=234,250)
11.8 scores on a scale
Standard Error 0.92
12.5 scores on a scale
Standard Error 1.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 7 (n=181,220)
10.9 scores on a scale
Standard Error 1.16
12.8 scores on a scale
Standard Error 1.22
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 10 (n=176,203)
8.5 scores on a scale
Standard Error 0.97
10.6 scores on a scale
Standard Error 1.19
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 13 (n=152,183)
8.8 scores on a scale
Standard Error 1.15
9.0 scores on a scale
Standard Error 1.09
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 16 (n=120,165)
10.2 scores on a scale
Standard Error 1.50
9.1 scores on a scale
Standard Error 1.09
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 19 (n=114,143)
9.5 scores on a scale
Standard Error 1.52
8.8 scores on a scale
Standard Error 1.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 22 (n=79,143)
10.0 scores on a scale
Standard Error 2.11
7.8 scores on a scale
Standard Error 1.19
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 25 (n=64,124)
6.9 scores on a scale
Standard Error 1.99
6.8 scores on a scale
Standard Error 1.27
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 28 (n=47,111)
6.6 scores on a scale
Standard Error 1.84
5.3 scores on a scale
Standard Error 1.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 31 (n=45,95)
6.4 scores on a scale
Standard Error 2.16
6.8 scores on a scale
Standard Error 1.40
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 34 (n=37,87)
3.9 scores on a scale
Standard Error 1.44
7.5 scores on a scale
Standard Error 1.51
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 37 (n=29,64)
5.4 scores on a scale
Standard Error 2.04
7.3 scores on a scale
Standard Error 2.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 40 (n=24,55)
3.7 scores on a scale
Standard Error 1.59
6.5 scores on a scale
Standard Error 1.82
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 43 (n=12,43)
4.6 scores on a scale
Standard Error 2.89
5.2 scores on a scale
Standard Error 1.63
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 46 (n=14,42)
2.4 scores on a scale
Standard Error 1.26
2.9 scores on a scale
Standard Error 1.08
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 49 (n=10,36)
4.4 scores on a scale
Standard Error 2.46
2.2 scores on a scale
Standard Error 0.74
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 52 (n=8,30)
1.4 scores on a scale
Standard Error 1.39
4.4 scores on a scale
Standard Error 1.81
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 55 (n=6,24)
0.0 scores on a scale
Standard Error 0.00
3.7 scores on a scale
Standard Error 1.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 58 (n=6,21)
3.7 scores on a scale
Standard Error 2.34
3.2 scores on a scale
Standard Error 1.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 61 (n=4,17)
2.8 scores on a scale
Standard Error 2.78
0.7 scores on a scale
Standard Error 0.65
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
3.3 scores on a scale
Standard Error 1.99
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 67 (n=4,16)
2.8 scores on a scale
Standard Error 2.78
2.8 scores on a scale
Standard Error 2.15
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
3.2 scores on a scale
Standard Error 2.45
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
4.6 scores on a scale
Standard Error 2.54
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
2.8 scores on a scale
Standard Error 1.82
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
2.5 scores on a scale
Standard Error 1.63
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
3.7 scores on a scale
Standard Error 2.34
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
1.9 scores on a scale
Standard Error 1.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
1.9 scores on a scale
Standard Error 1.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
1.9 scores on a scale
Standard Error 1.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
2.2 scores on a scale
Standard Error 2.22
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
2.8 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
2.2 scores on a scale
Standard Error 2.22
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dysphagia Scale: Final Visit (n=157,159
15.4 scores on a scale
Standard Error 1.77
17.0 scores on a scale
Standard Error 1.92
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: BL (n=276,287)
29.7 scores on a scale
Standard Error 1.32
27.0 scores on a scale
Standard Error 1.20
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 4 (n=234,250)
21.6 scores on a scale
Standard Error 1.15
21.8 scores on a scale
Standard Error 1.05
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 7 (n=181,219)
19.4 scores on a scale
Standard Error 1.26
20.1 scores on a scale
Standard Error 1.30
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 10 (n=176,203)
17.0 scores on a scale
Standard Error 1.11
17.5 scores on a scale
Standard Error 1.14
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 13 (n=152,183)
16.0 scores on a scale
Standard Error 1.25
16.2 scores on a scale
Standard Error 1.21
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 16 (n=120,165)
17.0 scores on a scale
Standard Error 1.45
15.9 scores on a scale
Standard Error 1.23
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 19 (n=114,143)
19.2 scores on a scale
Standard Error 1.95
16.3 scores on a scale
Standard Error 1.32
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 22 (n=79,143)
15.8 scores on a scale
Standard Error 2.05
15.1 scores on a scale
Standard Error 1.58
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 25 (n=64,124)
11.3 scores on a scale
Standard Error 1.82
14.4 scores on a scale
Standard Error 1.63
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 28 (n=47,111)
11.2 scores on a scale
Standard Error 1.95
14.0 scores on a scale
Standard Error 1.64
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 31 (n=45,95)
12.6 scores on a scale
Standard Error 2.33
14.6 scores on a scale
Standard Error 2.09
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 34 (n=37,87)
12.2 scores on a scale
Standard Error 2.18
12.5 scores on a scale
Standard Error 2.04
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 37 (n=29,64)
13.8 scores on a scale
Standard Error 2.90
13.8 scores on a scale
Standard Error 2.63
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 40 (n=24,55)
14.9 scores on a scale
Standard Error 2.97
11.8 scores on a scale
Standard Error 2.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 43 (n=12,43)
13.0 scores on a scale
Standard Error 3.41
9.7 scores on a scale
Standard Error 1.98
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 46 (n=14,42)
15.5 scores on a scale
Standard Error 3.13
10.1 scores on a scale
Standard Error 2.35
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 49 (n=10,36)
11.7 scores on a scale
Standard Error 4.51
9.5 scores on a scale
Standard Error 1.79
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 52 (n=8,30)
9.4 scores on a scale
Standard Error 4.00
8.6 scores on a scale
Standard Error 2.69
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 55 (n=6,24)
9.7 scores on a scale
Standard Error 5.01
4.5 scores on a scale
Standard Error 1.42
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 58 (n=6,21)
5.6 scores on a scale
Standard Error 4.12
6.3 scores on a scale
Standard Error 1.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 61 (n=4,17)
4.2 scores on a scale
Standard Error 2.41
5.4 scores on a scale
Standard Error 2.36
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 64 (n=3,20)
2.8 scores on a scale
Standard Error 2.78
9.6 scores on a scale
Standard Error 2.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 67 (n=4,16)
4.2 scores on a scale
Standard Error 4.17
8.3 scores on a scale
Standard Error 2.95
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 70 (n=3,14)
2.8 scores on a scale
Standard Error 2.78
6.5 scores on a scale
Standard Error 2.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
9.7 scores on a scale
Standard Error 3.95
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 76 (n=3,8)
5.6 scores on a scale
Standard Error 5.56
5.2 scores on a scale
Standard Error 2.19
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 79 (n=3,9)
2.8 scores on a scale
Standard Error 2.78
7.4 scores on a scale
Standard Error 3.79
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
6.9 scores on a scale
Standard Error 3.98
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 85 (n=2,6)
4.2 scores on a scale
Standard Error 4.17
5.6 scores on a scale
Standard Error 4.12
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 88 (n=2,6)
8.3 scores on a scale
Standard Error 8.33
5.6 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 91 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
2.1 scores on a scale
Standard Error 2.08
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 3.51
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 3.73
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.3 scores on a scale
Standard Error 2.08
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 3.40
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.3 scores on a scale
Standard Error 3.99
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 scores on a scale
Standard Error 2.41
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
10.0 scores on a scale
Standard Error 4.86
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 scores on a scale
Standard Error 2.41
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 3.73
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
10.0 scores on a scale
Standard Error 4.86
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 3.73
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
11.1 scores on a scale
Standard Error 7.35
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.9 scores on a scale
Standard Error 7.35
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Pain Scale: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
12.5 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
2.8 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 3.12
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.3 scores on a scale
Standard Error 3.99
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.3 scores on a scale
Standard Error 3.99
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.3 scores on a scale
Standard Error 3.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 3.12
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
5.0 scores on a scale
Standard Error 3.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
1.7 scores on a scale
Standard Error 1.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
8.3 scores on a scale
Standard Error 4.81
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
5.6 scores on a scale
Standard Error 2.78
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
4.2 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
ER Scale: Final Visit (n=157,160)
23.8 scores on a scale
Standard Error 1.85
22.8 scores on a scale
Standard Error 1.84
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: BL (n=276,287)
47.5 scores on a scale
Standard Error 1.66
48.2 scores on a scale
Standard Error 1.54
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 4 (n=234,250)
42.0 scores on a scale
Standard Error 1.66
43.8 scores on a scale
Standard Error 1.60
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 7 (n=181,220)
40.6 scores on a scale
Standard Error 1.77
39.3 scores on a scale
Standard Error 1.66
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 10 (n=176,203)
38.2 scores on a scale
Standard Error 1.98
38.2 scores on a scale
Standard Error 1.70
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 13 (n=152,183)
35.7 scores on a scale
Standard Error 2.01
37.5 scores on a scale
Standard Error 1.99
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 16 (n=120,165)
32.9 scores on a scale
Standard Error 2.27
37.1 scores on a scale
Standard Error 2.10
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 19 (n=114,143)
35.8 scores on a scale
Standard Error 2.40
34.9 scores on a scale
Standard Error 2.04
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 22 (n=79,143)
31.7 scores on a scale
Standard Error 3.16
32.8 scores on a scale
Standard Error 2.05
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 25 (n=64,124)
25.2 scores on a scale
Standard Error 2.86
29.2 scores on a scale
Standard Error 2.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 28 (n=47,111)
27.4 scores on a scale
Standard Error 3.65
26.9 scores on a scale
Standard Error 1.88
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 31 (n=45,95)
29.1 scores on a scale
Standard Error 4.36
28.4 scores on a scale
Standard Error 2.32
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 34 (n=37,87)
23.1 scores on a scale
Standard Error 3.69
27.8 scores on a scale
Standard Error 2.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 37 (n=29,64)
27.2 scores on a scale
Standard Error 4.79
28.2 scores on a scale
Standard Error 2.87
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 40 (n=24,55)
29.6 scores on a scale
Standard Error 3.99
26.3 scores on a scale
Standard Error 2.77
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 43 (n=12,43)
30.6 scores on a scale
Standard Error 7.63
25.1 scores on a scale
Standard Error 2.91
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 46 (n=14,42)
26.2 scores on a scale
Standard Error 6.34
23.3 scores on a scale
Standard Error 3.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 49 (n=14,42)
20.0 scores on a scale
Standard Error 7.55
25.9 scores on a scale
Standard Error 3.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 52 (n=8,30)
23.6 scores on a scale
Standard Error 7.98
27.4 scores on a scale
Standard Error 4.15
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 55 (n=6,24)
31.5 scores on a scale
Standard Error 12.31
28.2 scores on a scale
Standard Error 3.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 58 (n=6,21)
20.4 scores on a scale
Standard Error 10.11
21.7 scores on a scale
Standard Error 3.38
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 5.32
25.5 scores on a scale
Standard Error 5.37
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 64 (n=3,20)
5.6 scores on a scale
Standard Error 5.56
23.9 scores on a scale
Standard Error 4.21
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 67 (n=4,16)
11.1 scores on a scale
Standard Error 6.42
18.8 scores on a scale
Standard Error 3.47
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 70 (n=3,14)
3.7 scores on a scale
Standard Error 3.70
27.0 scores on a scale
Standard Error 5.91
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 73 (n=3,12)
7.4 scores on a scale
Standard Error 7.41
28.7 scores on a scale
Standard Error 6.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
27.8 scores on a scale
Standard Error 8.13
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 55 (n=6,24)
11.1 scores on a scale
Standard Error 7.03
4.2 scores on a scale
Standard Error 2.30
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 79 (n=3,9)
11.1 scores on a scale
Standard Error 11.11
33.3 scores on a scale
Standard Error 8.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 82 (n=2,6)
11.1 scores on a scale
Standard Error 11.11
25.9 scores on a scale
Standard Error 8.92
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 85 (n=2,6)
11.1 scores on a scale
Standard Error 11.11
24.1 scores on a scale
Standard Error 3.41
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 88 (n=2,6)
11.1 scores on a scale
Standard Error 11.11
14.8 scores on a scale
Standard Error 5.49
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 91 (n=2,4)
11.1 scores on a scale
Standard Error 11.11
22.2 scores on a scale
Standard Error 4.54
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 94 (n=2,6)
5.6 scores on a scale
Standard Error 5.56
22.2 scores on a scale
Standard Error 2.87
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
31.1 scores on a scale
Standard Error 5.44
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
22.2 scores on a scale
Standard Error 4.54
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
19.4 scores on a scale
Standard Error 5.32
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 7.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
22.2 scores on a scale
Standard Error 4.97
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
19.4 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
20.0 scores on a scale
Standard Error 6.48
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
15.6 scores on a scale
Standard Error 7.54
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 13 (n=66,80)
22.2 scores on a scale
Standard Error 3.40
20.4 scores on a scale
Standard Error 3.05
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
17.8 scores on a scale
Standard Error 5.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
22.2 scores on a scale
Standard Error 11.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
18.5 scores on a scale
Standard Error 9.80
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 37 (n=29,64)
23.0 scores on a scale
Standard Error 5.99
18.2 scores on a scale
Standard Error 3.48
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
18.5 scores on a scale
Standard Error 9.80
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
16.7 scores on a scale
Standard Error 16.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
11.1 scores on a scale
Standard Error 11.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
16.7 scores on a scale
Standard Error 16.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Week 145 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Anxiety Scale: Final Visit (n=157,160)
41.5 scores on a scale
Standard Error 2.19
40.9 scores on a scale
Standard Error 2.22
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: BL (n=274,287)
24.5 scores on a scale
Standard Error 1.70
23.9 scores on a scale
Standard Error 1.70
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 4 (n=232,249)
24.0 scores on a scale
Standard Error 1.81
23.3 scores on a scale
Standard Error 1.59
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 7 (n=180,219)
24.6 scores on a scale
Standard Error 2.02
26.9 scores on a scale
Standard Error 1.87
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 10 (n=176,203)
23.5 scores on a scale
Standard Error 1.85
25.0 scores on a scale
Standard Error 1.96
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 13 (n=152,183)
23.2 scores on a scale
Standard Error 2.06
21.1 scores on a scale
Standard Error 1.95
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 16 (n=120,165)
23.9 scores on a scale
Standard Error 2.41
23.4 scores on a scale
Standard Error 2.19
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 19 (n=113,143)
22.4 scores on a scale
Standard Error 2.56
20.5 scores on a scale
Standard Error 2.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 22 (n=79,143)
19.0 scores on a scale
Standard Error 2.92
16.3 scores on a scale
Standard Error 2.06
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 25 (n=64,124)
16.1 scores on a scale
Standard Error 3.06
12.1 scores on a scale
Standard Error 1.80
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 28 (n=47,111)
10.6 scores on a scale
Standard Error 2.51
10.8 scores on a scale
Standard Error 1.55
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 31 (n=45,95)
12.6 scores on a scale
Standard Error 3.23
11.2 scores on a scale
Standard Error 2.21
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 34 (n=37,87)
9.9 scores on a scale
Standard Error 3.38
9.6 scores on a scale
Standard Error 1.88
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 37 (n=29,64)
12.6 scores on a scale
Standard Error 4.19
9.4 scores on a scale
Standard Error 2.28
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 40 (n=23,55)
8.7 scores on a scale
Standard Error 3.76
7.3 scores on a scale
Standard Error 2.40
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 43 (n=12,43)
11.1 scores on a scale
Standard Error 4.74
6.2 scores on a scale
Standard Error 2.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 46 (n=14,42)
9.5 scores on a scale
Standard Error 4.18
4.8 scores on a scale
Standard Error 1.82
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 49 (n=10,36)
16.7 scores on a scale
Standard Error 5.56
6.5 scores on a scale
Standard Error 2.23
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 52 (n=8,30)
12.5 scores on a scale
Standard Error 6.10
10.0 scores on a scale
Standard Error 3.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 55 (n=6,24)
5.6 scores on a scale
Standard Error 5.56
8.3 scores on a scale
Standard Error 3.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
14.3 scores on a scale
Standard Error 4.35
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
11.8 scores on a scale
Standard Error 4.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
6.7 scores on a scale
Standard Error 3.06
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 67 (n=4,16)
8.3 scores on a scale
Standard Error 8.33
8.3 scores on a scale
Standard Error 4.81
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
11.9 scores on a scale
Standard Error 5.64
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
13.9 scores on a scale
Standard Error 4.95
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
20.8 scores on a scale
Standard Error 8.77
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 85 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.0
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Dry Mouth: Final Visit (n=157,157)
24.0 scores on a scale
Standard Error 2.52
23.6 scores on a scale
Standard Error 2.43
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: BL (n=275,286)
17.2 scores on a scale
Standard Error 1.56
17.9 scores on a scale
Standard Error 1.64
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 4 (n=234,249)
20.7 scores on a scale
Standard Error 1.63
24.8 scores on a scale
Standard Error 1.79
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 7 (n=179,217)
20.1 scores on a scale
Standard Error 1.78
24.0 scores on a scale
Standard Error 1.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 10 (n=176,200)
21.8 scores on a scale
Standard Error 1.86
25.3 scores on a scale
Standard Error 2.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 13 (n=151,181)
19.9 scores on a scale
Standard Error 2.08
25.2 scores on a scale
Standard Error 2.20
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 16 (n=119,165)
20.4 scores on a scale
Standard Error 2.22
23.8 scores on a scale
Standard Error 2.23
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 19 (n=113,143)
24.5 scores on a scale
Standard Error 2.37
22.6 scores on a scale
Standard Error 2.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 22 (n=79,143)
19.0 scores on a scale
Standard Error 2.86
19.6 scores on a scale
Standard Error 2.15
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 25 (n=64,124)
10.9 scores on a scale
Standard Error 2.23
15.9 scores on a scale
Standard Error 1.96
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 28 (n=47,111)
12.1 scores on a scale
Standard Error 2.76
14.7 scores on a scale
Standard Error 2.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 31 (n=45,95)
8.1 scores on a scale
Standard Error 2.63
13.0 scores on a scale
Standard Error 2.65
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 34 (n=37,87)
6.3 scores on a scale
Standard Error 2.53
9.6 scores on a scale
Standard Error 2.10
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 37 (n=28,64)
8.3 scores on a scale
Standard Error 3.26
7.8 scores on a scale
Standard Error 2.20
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 40 (n=24,55)
8.3 scores on a scale
Standard Error 3.01
7.9 scores on a scale
Standard Error 2.73
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 43 (n=12,43)
5.6 scores on a scale
Standard Error 3.75
7.0 scores on a scale
Standard Error 2.09
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 46 (n=14,42)
4.8 scores on a scale
Standard Error 3.24
7.9 scores on a scale
Standard Error 2.74
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 49 (n=9,36)
7.4 scores on a scale
Standard Error 4.90
4.6 scores on a scale
Standard Error 1.95
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 52 (n=8,30)
4.2 scores on a scale
Standard Error 4.17
7.8 scores on a scale
Standard Error 3.46
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 67 (n=4,16)
0.0 scores on a scale
Standard Error 0.00
14.6 scores on a scale
Standard Error 4.27
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 85 (n=2, 6)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 88 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 91 (n=2,4)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 94 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
5.6 scores on a scale
Standard Error 5.56
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 40 (n=24,55)
20.8 scores on a scale
Standard Error 5.96
19.4 scores on a scale
Standard Error 3.53
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 43 (n=12,43)
27.8 scores on a scale
Standard Error 6.91
15.5 scores on a scale
Standard Error 3.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 46 (n=14,42)
21.4 scores on a scale
Standard Error 6.64
15.9 scores on a scale
Standard Error 3.81
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 49 (n=10,36)
16.7 scores on a scale
Standard Error 7.45
13.9 scores on a scale
Standard Error 4.07
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 52 (n=8,30)
16.7 scores on a scale
Standard Error 8.91
16.7 scores on a scale
Standard Error 3.83
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 55 (n=6,24)
16.7 scores on a scale
Standard Error 11.39
16.7 scores on a scale
Standard Error 4.91
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
15.9 scores on a scale
Standard Error 5.45
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 58 (n=6,21)
11.1 scores on a scale
Standard Error 7.03
4.8 scores on a scale
Standard Error 2.61
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 70 (n=4,14)
0.0 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 5.79
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
13.7 scores on a scale
Standard Error 5.76
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 73 (n=3,12)
0.0 scores on a scale
Standard Error 0.00
27.8 scores on a scale
Standard Error 9.02
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 64 (n=3,20)
0.0 scores on a scale
Standard Error 0.00
18.3 scores on a scale
Standard Error 4.51
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 76 (n=3,8)
0.0 scores on a scale
Standard Error 0.00
37.5 scores on a scale
Standard Error 11.68
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 79 (n=3,9)
0.0 scores on a scale
Standard Error 0.00
25.9 scores on a scale
Standard Error 9.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 82 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
16.7 scores on a scale
Standard Error 7.45
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 85 (n=2,6)
0.0 scores on a scale
Standard Error 0.00
11.1 scores on a scale
Standard Error 7.03
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 88 (n=2,5)
0.0 scores on a scale
Standard Error 0.00
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 61 (n=4,17)
8.3 scores on a scale
Standard Error 8.33
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 64 (n=3,20)
11.1 scores on a scale
Standard Error 11.11
1.7 scores on a scale
Standard Error 1.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 67 (n=4,16)
8.3 scores on a scale
Standard Error 8.33
4.2 scores on a scale
Standard Error 2.85
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 70 (n=3,14)
0.0 scores on a scale
Standard Error 0.00
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 97 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
13.3 scores on a scale
Standard Error 8.16
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 100 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 103 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 106 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 109 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 112 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 115 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 9.62
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 118 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 121 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 124 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.67 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 127 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 130 (n=0,3)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Taste: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 133 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
11.1 scores on a scale
Standard Error 11.11
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 136 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
16.7 scores on a scale
Standard Error 16.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 139 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 142 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
16.7 scores on a scale
Standard Error 16.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Week 145 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Body Image: Final Visit (n=157,159)
31.0 scores on a scale
Standard Error 2.58
30.4 scores on a scale
Standard Error 2.42
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: BL (n=64,76)
15.1 scores on a scale
Standard Error 3.31
25.0 scores on a scale
Standard Error 3.80
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 4 (n=68,71)
20.1 scores on a scale
Standard Error 3.43
16.4 scores on a scale
Standard Error 2.90
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 7 (n=65,82)
25.1 scores on a scale
Standard Error 3.27
19.1 scores on a scale
Standard Error 3.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 10 (n=75,78)
21.8 scores on a scale
Standard Error 3.07
20.1 scores on a scale
Standard Error 2.81
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 16 (n=53,72)
28.3 scores on a scale
Standard Error 4.34
23.6 scores on a scale
Standard Error 3.26
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 19 (n=50,56)
23.3 scores on a scale
Standard Error 4.29
21.4 scores on a scale
Standard Error 3.55
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 22 (n=38,54)
20.2 scores on a scale
Standard Error 4.45
22.2 scores on a scale
Standard Error 3.52
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 25 (n=24,49)
13.9 scores on a scale
Standard Error 4.88
18.4 scores on a scale
Standard Error 3.64
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 28 (n=20,39)
26.7 scores on a scale
Standard Error 7.87
14.5 scores on a scale
Standard Error 4.38
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 31 (n=17,26)
15.7 scores on a scale
Standard Error 7.07
10.3 scores on a scale
Standard Error 4.44
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 34 (n=13,24)
7.7 scores on a scale
Standard Error 5.54
16.7 scores on a scale
Standard Error 5.68
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 37 (n=12,16)
8.3 scores on a scale
Standard Error 5.98
12.5 scores on a scale
Standard Error 4.17
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 40 (n=11,13)
12.1 scores on a scale
Standard Error 6.78
12.8 scores on a scale
Standard Error 6.01
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 43 (n=5,9)
6.7 scores on a scale
Standard Error 6.67
3.7 scores on a scale
Standard Error 3.70
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 46 (n=5,13)
26.7 scores on a scale
Standard Error 19.44
5.1 scores on a scale
Standard Error 3.47
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 49 (n=4,7)
0.0 scores on a scale
Standard Error 0.00
9.5 scores on a scale
Standard Error 6.15
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 52 (n=3,4)
11.1 scores on a scale
Standard Error 11.11
8.3 scores on a scale
Standard Error 8.33
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 55 (n=2,6)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 58 (n=2,3)
16.7 scores on a scale
Standard Error 16.67
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 61 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
16.7 scores on a scale
Standard Error 16.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 64 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 67 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 70 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 73 (n=1,5)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.7 scores on a scale
Standard Error 6.67
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 76 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 79 (n=1,4)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 82 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 85 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 88 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 91 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 94 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 97 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 100 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 103 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 106 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 109 (n=0,2)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 112 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 115 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 118 (n=1,3)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 121 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 124 (n=1,2)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error 0.00
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 127 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 130 (n=0,1)
NA scores on a scale
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Week 133 (n=1,1)
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.0 scores on a scale
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Hair Loss: Final Visit (n=61,60)
23.0 scores on a scale
Standard Error 3.62
19.4 scores on a scale
Standard Error 3.29

SECONDARY outcome

Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS; n = number of participants assessed for a specific parameter at a given visit.

The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
BL (n=275,284)
21.1 mm
Standard Error 1.42
17.9 mm
Standard Error 1.25
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 4 (n=234,249)
14.6 mm
Standard Error 1.17
13.3 mm
Standard Error 1.11
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 7 (n=181,219)
11.1 mm
Standard Error 1.15
13.8 mm
Standard Error 1.31
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 10 (n=174, 202)
14.5 mm
Standard Error 1.46
12.9 mm
Standard Error 1.30
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 13 (n=152,181)
11.3 mm
Standard Error 1.37
12.2 mm
Standard Error 1.35
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 16 (n=121,165)
14.0 mm
Standard Error 1.77
12.8 mm
Standard Error 1.53
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 19 (n=114,142)
15.4 mm
Standard Error 1.92
12.0 mm
Standard Error 1.43
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 22 (n=79,141)
13.3 mm
Standard Error 2.20
15.1 mm
Standard Error 1.81
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 25 (n=64,124)
12.7 mm
Standard Error 2.39
11.0 mm
Standard Error 1.50
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 28 (n=47,111)
8.6 mm
Standard Error 1.85
12.3 mm
Standard Error 1.80
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 31 (n=45,95)
8.7 mm
Standard Error 2.11
12.5 mm
Standard Error 1.92
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 34 (n=37,86)
9.4 mm
Standard Error 2.90
10.7 mm
Standard Error 1.79
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 37 (n=29,64)
15.5 mm
Standard Error 4.08
10.9 mm
Standard Error 2.22
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 40 (n=24,54)
16.4 mm
Standard Error 4.20
8.8 mm
Standard Error 1.99
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 43 (n=12,43)
12.6 mm
Standard Error 5.04
7.2 mm
Standard Error 2.15
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 46 (n=14,41)
16.1 mm
Standard Error 6.11
7.4 mm
Standard Error 2.30
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 49 (n=10,36)
7.2 mm
Standard Error 3.71
6.5 mm
Standard Error 2.09
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 52 (n=8,30)
5.8 mm
Standard Error 3.43
6.9 mm
Standard Error 2.75
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 55 (n=6,24)
2.3 mm
Standard Error 1.20
3.3 mm
Standard Error 1.48
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 58 (n=6,20)
4.7 mm
Standard Error 2.20
3.8 mm
Standard Error 1.91
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 61 (n=4,17)
5.3 mm
Standard Error 3.04
7.2 mm
Standard Error 5.03
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 64 (n=3,20)
2.0 mm
Standard Error 1.00
6.8 mm
Standard Error 3.14
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 67 (n=4,17)
1.5 mm
Standard Error 0.96
8.9 mm
Standard Error 5.04
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 70 (n=3,13)
1.3 mm
Standard Error 1.33
1.3 mm
Standard Error 1.15
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 73 (n=3,10)
1.0 mm
Standard Error 0.58
16.5 mm
Standard Error 8.30
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 76 (n=3,8)
1.7 mm
Standard Error 0.88
12.9 mm
Standard Error 11.12
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 79 (n=3,9)
1.0 mm
Standard Error 0.58
5.9 mm
Standard Error 3.89
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 82 (n=2,6)
0.0 mm
Standard Error 0.00
4.8 mm
Standard Error 4.83
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 85 (n=2,6)
1.0 mm
Standard Error 1.00
6.3 mm
Standard Error 6.14
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 88 (n=2,6)
0.5 mm
Standard Error 0.50
5.7 mm
Standard Error 5.47
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 91 (n=2,4)
0.5 mm
Standard Error 0.50
7.5 mm
Standard Error 6.85
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 94 (n=2,6)
0.5 mm
Standard Error 0.50
5.8 mm
Standard Error 5.83
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 97 (n=1,5)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.2 mm
Standard Error 0.20
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 100 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
0.3 mm
Standard Error .25
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 103 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.5 mm
Standard Error 5.85
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 106 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
7.8 mm
Standard Error 6.79
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 109 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
7.3 mm
Standard Error 7.25
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 112 (n=1,5)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.2 mm
Standard Error 3.50
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 115 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
5.8 mm
Standard Error 5.11
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 118 (n=1,5)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.8 mm
Standard Error 3.32
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 121 (n=1,5)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
3.2 mm
Standard Error 3.20
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 124 (n=1,4)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
4.5 mm
Standard Error 3.84
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 127 (n=1,3)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
6.3 mm
Standard Error 6.33
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 130 (n=0,3)
NA mm
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
5.7 mm
Standard Error 5.67
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 133 (n=1,3)
0.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
5.0 mm
Standard Error 5.00
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 136 (n=0,2)
NA mm
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
6.0 mm
Standard Error 6.00
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 139 (n=0,2)
NA mm
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
8.0 mm
Standard Error 8.00
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 142 (n=0,2)
NA mm
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
7.5 mm
Standard Error 7.50
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Week 145 (n=0,1)
NA mm
Standard Error NA
No participants were analyzed in this treatment group for this timepoint.
15.0 mm
Standard Error NA
Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
Final visit/withdrawal (n=157,161)
23.8 mm
Standard Error 1.99
21.9 mm
Standard Error 2.18

SECONDARY outcome

Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS

Analgesic medications were recorded throughout the study until disease progression.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Percentage of Participants With a Change in Analgesic Medication During the Study
No change in any medication
5.5 percentage of participants
7.1 percentage of participants
Percentage of Participants With a Change in Analgesic Medication During the Study
Taking any analgesic medication
29.0 percentage of participants
29.3 percentage of participants
Percentage of Participants With a Change in Analgesic Medication During the Study
Discontinued at least 1 medication
5.9 percentage of participants
1.7 percentage of participants
Percentage of Participants With a Change in Analgesic Medication During the Study
Decreased dose of at least 1 medication
0.3 percentage of participants
0.3 percentage of participants
Percentage of Participants With a Change in Analgesic Medication During the Study
Increased dose or added at least 1 medication
17.2 percentage of participants
20.1 percentage of participants

SECONDARY outcome

Timeframe: BL

Population: FAS

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Body Weight (Kilograms [kg]) at BL
60 kg
Interval 28.0 to 105.0
61 kg
Interval 35.0 to 110.0

SECONDARY outcome

Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Population: FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.

Change in body weight was categorized as an increase of greater than (\>)5 percent (%), no change (plus or minus \[±\]5%), decrease of \>5-10%, or a decrease of \>10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=273 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=283 Participants
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
Increase >5%
1.5 percentage of participants
1.1 percentage of participants
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
No change (±5%)
51.6 percentage of participants
50.5 percentage of participants
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
Decrease >5-10%
28.2 percentage of participants
27.2 percentage of participants
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
Decrease >10%
18.7 percentage of participants
21.2 percentage of participants

SECONDARY outcome

Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

Population: Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.

Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by \[\*\] day per liter \[L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=266 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Steady State Trastuzumab Area Under the Concentration (AUC)
1030 mg*day/L
Interval 565.0 to 1726.0

SECONDARY outcome

Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

Population: PK Population

Median Cmin (measured as milligrams per liter \[mg/L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=266 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab Minimum Serum Concentration (Cmin)
23.0 mg/L
Interval 6.4 to 48.5

SECONDARY outcome

Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

Population: PK Population

Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.

Outcome measures

Outcome measures
Measure
Fluoropyrimidine/Cisplatin (FP)
n=266 Participants
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab Maximum Serum Concentration (Cmax)
128 mg/L
Interval 93.1 to 178.0

Adverse Events

Fluoropyrimidine/Cisplatin (FP)

Serious events: 81 serious events
Other events: 279 other events
Deaths: 0 deaths

Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

Serious events: 106 serious events
Other events: 286 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 participants at risk
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 participants at risk
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Gastrointestinal disorders
Diarrhoea
2.1%
6/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
6.1%
18/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Vomiting
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
2.7%
8/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Dysphagia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
3.1%
9/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Nausea
1.4%
4/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Abdominal pain
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastrointestinal haemorrage
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Enteritis
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastric haemorrhage
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastric perforation
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastrointestinal obstruction
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Ileus
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Obstruction gastric
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Peritonitus
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Abdominal distension
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Constipation
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Enterocolitis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastritis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastrointestinal hypomotility
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Gastrointestinal perforation
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Haematemesis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
lleus paralytic
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Pancreatitis acute
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Reflux oesophagitis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Stomatitis
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Febrile neutropenia
2.8%
8/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
3.7%
11/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Anaemia
2.4%
7/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.4%
4/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Neutropenia
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Pancytopenia
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Haematotoxicity
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Pneumonia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
2.0%
6/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Septic shock
1.7%
5/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Respiratory tract infection
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Infection
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Biliary sepsis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Escherichia infection
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Fungaemia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Gastroenteritis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Gastroenteritis viral
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Oesophageal candidiasis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Oral candidiasis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Pneumococcal infection
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Pseudomembranous colitis
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Sepsis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Tuberculosis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Asthenia
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Mucosal inflammation
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Pyrexia
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
2.0%
6/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Death
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.4%
4/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Chest pain
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Fatigue
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Ill-defined disorder
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Oedema peripheral
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Dehydration
2.1%
6/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
2.4%
7/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Decreased appetite
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.7%
5/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Hyponatraemia
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Gout
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Hyperkalaemia
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Cerebrovascular accident
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Cerebral infarcation
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Depressed level of consciousness
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Cerebral disorder
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Convulsion
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Grand mal convulsion
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Haemorrhage intracranial
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Hypoglycaemic coma
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Ischaemic stroke
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Lethargy
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.0%
3/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Deep vein thrombosis
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Orthostatic hypotension
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Femoral artery occlusion
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Hypertension
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Hypotension
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Jugular vein thrombosis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Peripheral ischaemia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Vascular disorders
Venous thrombosis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Renal failure acute
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
1.0%
3/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Renal failure
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Renal impairment
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Haematuria
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Obstructive uropathy
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Urinary retention
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Cardiac failure
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Myocardial infarction
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Acute myocardial infarction
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Angina unstable
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Cardiac arrest
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Cardio-respiratory arrest
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Weight decreased
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Blood bilirubin increased
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Blood creatinine increased
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Blood pressure decreased
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Creatinine renal clearance decreased
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Ejection fraction decreased
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Hepatobiliary disorders
Cholecystitis
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Injury, poisoning and procedural complications
Anastomotic stenosis
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Injury, poisoning and procedural complications
Device migration
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Injury, poisoning and procedural complications
Overdose
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Injury, poisoning and procedural complications
Stent occlusion
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Musculoskeletal and connective tissue disorders
Back pain
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Musculoskeletal and connective tissue disorders
Joint swelling
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Congenital, familial and genetic disorders
Pyloric stenosis
0.69%
2/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Psychiatric disorders
Anxiety
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Psychiatric disorders
Completed suicide
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Upper respiratory tract infection
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.68%
2/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Arthritis infective
0.34%
1/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.00%
0/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Cardiac disorders
Cardiac failure congestive
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
0.34%
1/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.

Other adverse events

Other adverse events
Measure
Fluoropyrimidine/Cisplatin (FP)
n=290 participants at risk
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
n=294 participants at risk
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Gastrointestinal disorders
Nausea
65.2%
189/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
68.0%
200/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Vomiting
46.6%
135/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
49.7%
146/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Diarrhoea
28.3%
82/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
34.7%
102/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Constipation
32.8%
95/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
25.9%
76/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Stomatitis
15.5%
45/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
24.8%
73/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Abdominal pain
14.1%
41/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
15.3%
45/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Abdominal pain upper
7.2%
21/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
10.9%
32/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Dyspepsia
5.9%
17/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
6.8%
20/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Gastrointestinal disorders
Dysphagia
3.8%
11/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.8%
17/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Neutropenia
56.6%
164/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
53.4%
157/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Anaemia
21.7%
63/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
28.2%
83/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Blood and lymphatic system disorders
Thrombocytopenia
11.7%
34/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
16.0%
47/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Fatigue
29.7%
86/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
36.1%
106/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Asthenia
18.3%
53/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
20.1%
59/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Pyrexia
12.4%
36/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
18.0%
53/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Mucosal inflammation
5.2%
15/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
13.3%
39/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Oedema
9.0%
26/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
8.5%
25/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Oedema peripheral
4.5%
13/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
6.1%
18/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
General disorders
Chills
0.00%
0/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
7.8%
23/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Decreased appetite
47.2%
137/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
46.9%
138/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Hypokalaemia
4.8%
14/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
7.1%
21/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Metabolism and nutrition disorders
Dehydration
3.8%
11/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.1%
15/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodysaesthesia syndrome
22.8%
66/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
26.5%
78/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Alopecia
10.3%
30/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
12.2%
36/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Pigmentation disorder
5.9%
17/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
6.5%
19/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Skin and subcutaneous tissue disorders
Rash
4.5%
13/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.8%
17/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Dizziness
10.0%
29/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
10.5%
31/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Peripheral sensory neuropathy
9.3%
27/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
9.5%
28/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Neuropathy peripheral
8.6%
25/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
8.8%
26/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Dysgeusia
5.5%
16/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
9.5%
28/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Nervous system disorders
Headache
6.9%
20/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.1%
15/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Weight decreased
13.8%
40/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
23.1%
68/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Creatinine renal clearance decreased
6.6%
19/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
8.2%
24/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Investigations
Weight increased
5.2%
15/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
7.1%
21/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Hiccups
10.0%
29/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
11.9%
35/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Cough
5.9%
17/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
7.5%
22/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
6.6%
19/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
3.7%
11/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Respiratory, thoracic and mediastinal disorders
Epistaxis
3.4%
10/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.1%
15/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Renal impairment
13.1%
38/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
15.6%
46/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Renal and urinary disorders
Nephropathy toxic
4.1%
12/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
6.1%
18/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Infections and infestations
Nasopharyngitis
5.9%
17/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
13.6%
40/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Psychiatric disorders
Insomnia
7.6%
22/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
9.2%
27/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
Musculoskeletal and connective tissue disorders
Back pain
5.2%
15/290 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
5.1%
15/294 • Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER