Trial Outcomes & Findings for A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW). (NCT NCT03653507)
NCT ID: NCT03653507
Last Updated: 2026-02-06
Results Overview
PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 by independent review committee \[IRC\]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
From the date of randomization until 61 months and 12 days
Results posted on
2026-02-06
Participant Flow
Participants with claudin (CLDN)18.2-positive, human epidermal growth factor receptor 2 (HER2) -negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Randomization was stratified by region (Asia vs Non-Asia), number of organs with metastatic sites (0 to 2 vs ≥ 3) and prior gastrectomy (Yes or No)
Participant milestones
| Measure |
CAPOX+ Zolbetuximab
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
CAPOX+ Placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
249
|
|
Overall Study
COMPLETED
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
245
|
247
|
Reasons for withdrawal
| Measure |
CAPOX+ Zolbetuximab
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
CAPOX+ Placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Overall Study
Miscellaneous
|
28
|
19
|
|
Overall Study
Withdrawal by Subject
|
37
|
22
|
|
Overall Study
Protocol Deviation
|
2
|
1
|
|
Overall Study
Progressive disease
|
117
|
168
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
25
|
22
|
|
Overall Study
Adverse Event
|
35
|
14
|
Baseline Characteristics
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).
Baseline characteristics by cohort
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 12.1 • n=192 Participants
|
56.7 Years
STANDARD_DEVIATION 13 • n=170 Participants
|
57.6 Years
STANDARD_DEVIATION 12.6 • n=185 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=192 Participants
|
97 Participants
n=170 Participants
|
192 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=192 Participants
|
156 Participants
n=170 Participants
|
315 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=192 Participants
|
7 Participants
n=170 Participants
|
17 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
242 Participants
n=192 Participants
|
241 Participants
n=170 Participants
|
483 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=192 Participants
|
5 Participants
n=170 Participants
|
7 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
158 Participants
n=192 Participants
|
158 Participants
n=170 Participants
|
316 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=192 Participants
|
90 Participants
n=170 Participants
|
184 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=192 Participants
|
5 Participants
n=170 Participants
|
7 Participants
n=185 Participants
|
|
Region (Asia vs Non-Asia)
Asia
|
157 Participants
n=192 Participants
|
158 Participants
n=170 Participants
|
315 Participants
n=185 Participants
|
|
Region (Asia vs Non-Asia)
Non-Asia
|
97 Participants
n=192 Participants
|
95 Participants
n=170 Participants
|
192 Participants
n=185 Participants
|
|
Number of organs with metastatic sites
0-2 metastatic sites
|
189 Participants
n=192 Participants
|
188 Participants
n=170 Participants
|
377 Participants
n=185 Participants
|
|
Number of organs with metastatic sites
>=3 metastatic sites
|
65 Participants
n=192 Participants
|
65 Participants
n=170 Participants
|
130 Participants
n=185 Participants
|
|
Prior Gastrectomy
Yes
|
75 Participants
n=192 Participants
|
75 Participants
n=170 Participants
|
150 Participants
n=185 Participants
|
|
Prior Gastrectomy
No
|
179 Participants
n=192 Participants
|
178 Participants
n=170 Participants
|
357 Participants
n=185 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 by independent review committee \[IRC\]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
8.21 Months
Interval 7.26 to 8.84
|
6.80 Months
Interval 6.14 to 8.08
|
SECONDARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Overall Survival (OS)
|
14.32 Months
Interval 12.09 to 16.39
|
12.16 Months
Interval 10.28 to 13.67
|
SECONDARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
TTCD: time from randomization to first clinically meaning full deterioration (CMFD) that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's change from baseline (CFB) exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Physical Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
|
7.95 Months
Interval 5.88 to 19.78
|
7.92 Months
Interval 6.47 to 11.3
|
SECONDARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
TTCD:time from randomization to first CMFD confirmed at next scheduled visit.OG25 evaluated gastric \& gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain, discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100; higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. CMFD: if participant's CFB exceeded pre-specified threshold (per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25 Plus STO22 Belching Subscale
|
NA Months
Interval 28.16 to
Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM.
|
25.82 Months
Interval 18.46 to
The lower bound of the confidence interval for the median survival time may not be estimable, even if the median itself can be calculated, in scenarios with significant early censoring and a limited number of events
|
SECONDARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
TTCD: time from randomization to first CMFD that was confirmed at the next scheduled visit.The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 (very poor) to 7 (excellent). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's CFB exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
|
9.40 Months
Interval 7.36 to 24.8
|
7.49 Months
Interval 6.11 to 9.86
|
SECONDARY outcome
Timeframe: From the date of randomization until 61 months and 12 daysPopulation: FAS
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=253 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
42.5 Percentage of Participants
Interval 36.36 to 48.85
|
39.1 Percentage of Participants
Interval 33.08 to 45.44
|
SECONDARY outcome
Timeframe: From first response (CR/PR) until 61 months and 12 daysPopulation: FAS- All Objective Responders
DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=108 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=102 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Duration Of Response (DOR)
|
6.28 Months
Interval 5.39 to 8.28
|
6.08 Months
Interval 4.44 to 6.34
|
SECONDARY outcome
Timeframe: From first dose until 61 months and 12 daysPopulation: FAS
An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=254 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=249 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
251 Participants
|
244 Participants
|
SECONDARY outcome
Timeframe: Baseline, cycle (C) 1 day (D)1 through C60 D1Population: FAS
ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=253 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=250 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 1
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C59D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 1
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C60D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 0
|
26 Participants
|
16 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 1
|
21 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 0
|
22 Participants
|
14 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 1
|
21 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 0
|
24 Participants
|
15 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 1
|
19 Participants
|
6 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 0
|
23 Participants
|
15 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 1
|
17 Participants
|
7 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 0
|
17 Participants
|
12 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 1
|
15 Participants
|
5 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 0
|
20 Participants
|
14 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 1
|
14 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 0
|
19 Participants
|
11 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 1
|
13 Participants
|
5 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 0
|
17 Participants
|
11 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 1
|
14 Participants
|
5 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 0
|
108 Participants
|
108 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 1
|
145 Participants
|
142 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 0
|
85 Participants
|
97 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 1
|
129 Participants
|
126 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 2
|
5 Participants
|
2 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 0
|
80 Participants
|
91 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 1
|
116 Participants
|
117 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 2
|
0 Participants
|
2 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 0
|
74 Participants
|
79 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 1
|
106 Participants
|
98 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 2
|
0 Participants
|
2 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 0
|
68 Participants
|
75 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 1
|
98 Participants
|
98 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 2
|
2 Participants
|
2 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 0
|
71 Participants
|
72 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 1
|
86 Participants
|
80 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 2
|
2 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 3
|
0 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 0
|
52 Participants
|
60 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 1
|
67 Participants
|
76 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 3
|
1 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 0
|
49 Participants
|
44 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 1
|
63 Participants
|
70 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 0
|
47 Participants
|
47 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 1
|
57 Participants
|
59 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 0
|
39 Participants
|
40 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 1
|
47 Participants
|
44 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 0
|
41 Participants
|
34 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 1
|
45 Participants
|
43 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 0
|
39 Participants
|
29 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 1
|
38 Participants
|
36 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 0
|
33 Participants
|
24 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 1
|
34 Participants
|
30 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 0
|
32 Participants
|
20 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 1
|
32 Participants
|
28 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 0
|
24 Participants
|
16 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 1
|
30 Participants
|
25 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 0
|
23 Participants
|
18 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 1
|
27 Participants
|
17 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 0
|
22 Participants
|
17 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 1
|
24 Participants
|
12 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 0
|
19 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 1
|
11 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 0
|
17 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 1
|
11 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 0
|
17 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 1
|
7 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 0
|
17 Participants
|
8 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 1
|
7 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 0
|
15 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 1
|
7 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 0
|
15 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 1
|
7 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 0
|
13 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 1
|
6 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 0
|
11 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 1
|
5 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 0
|
11 Participants
|
4 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 1
|
3 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 0
|
10 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 1
|
5 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 0
|
10 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 1
|
6 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 0
|
9 Participants
|
3 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 1
|
5 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 0
|
8 Participants
|
2 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 0
|
8 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 1
|
3 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 1
|
5 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 0
|
8 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 1
|
3 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C40D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 0
|
8 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 1
|
3 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C41D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 0
|
7 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 1
|
3 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C42D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 0
|
5 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 1
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C43D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 0
|
7 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 1
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C44D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 0
|
7 Participants
|
1 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 1
|
2 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C45D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 0
|
7 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C46D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 0
|
6 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C47D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 0
|
5 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C48D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 0
|
3 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C49D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 0
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C50D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 0
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C51D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 0
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 1
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C52D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 0
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 1
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C53D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 0
|
2 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 1
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C54D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 1
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C55D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 1
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C56D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 1
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C57D1 Score 5
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 0
|
1 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 1
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 2
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 3
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 4
|
0 Participants
|
—
|
|
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
C58D1 Score 5
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow upPopulation: FAS with available data was analyzed.
The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.It is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=243 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=242 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C15D1
|
-6.54 Unit on a scale
Standard Deviation 19.17
|
-7.41 Unit on a scale
Standard Deviation 21.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C4D1
|
-4.73 Unit on a scale
Standard Deviation 28.47
|
-5.13 Unit on a scale
Standard Deviation 27.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C6D1
|
-5.15 Unit on a scale
Standard Deviation 28.40
|
-2.51 Unit on a scale
Standard Deviation 30.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C7D1
|
-5.28 Unit on a scale
Standard Deviation 28.34
|
-2.91 Unit on a scale
Standard Deviation 31.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C8D1
|
0.31 Unit on a scale
Standard Deviation 29.00
|
-4.85 Unit on a scale
Standard Deviation 25.48
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C9D1
|
-4.90 Unit on a scale
Standard Deviation 29.44
|
-4.21 Unit on a scale
Standard Deviation 27.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C10D1
|
-5.49 Unit on a scale
Standard Deviation 29.48
|
-0.42 Unit on a scale
Standard Deviation 28.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C11D1
|
-2.47 Unit on a scale
Standard Deviation 29.71
|
0.94 Unit on a scale
Standard Deviation 30.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C17D1
|
1.55 Unit on a scale
Standard Deviation 25.15
|
12.00 Unit on a scale
Standard Deviation 31.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C18D1
|
0.00 Unit on a scale
Standard Deviation 24.72
|
4.76 Unit on a scale
Standard Deviation 24.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C19D1
|
0.00 Unit on a scale
Standard Deviation 21.35
|
6.67 Unit on a scale
Standard Deviation 38.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C20D1
|
-0.85 Unit on a scale
Standard Deviation 17.91
|
7.02 Unit on a scale
Standard Deviation 23.78
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C21D1
|
0.00 Unit on a scale
Standard Deviation 19.52
|
8.33 Unit on a scale
Standard Deviation 30.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C22D1
|
-5.38 Unit on a scale
Standard Deviation 17.42
|
9.80 Unit on a scale
Standard Deviation 34.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C13D1
|
-7.78 Unit on a scale
Standard Deviation 25.58
|
-3.47 Unit on a scale
Standard Deviation 33.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C16D1
|
-2.08 Unit on a scale
Standard Deviation 25.18
|
6.45 Unit on a scale
Standard Deviation 26.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C23D1
|
3.23 Unit on a scale
Standard Deviation 23.34
|
4.17 Unit on a scale
Standard Deviation 23.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C29D1
|
3.03 Unit on a scale
Standard Deviation 17.55
|
0.00 Unit on a scale
Standard Deviation 14.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C38D1
|
-6.67 Unit on a scale
Standard Deviation 14.05
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C12D1
|
-0.22 Unit on a scale
Standard Deviation 13.83
|
1.17 Unit on a scale
Standard Deviation 16.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C13D1
|
-0.28 Unit on a scale
Standard Deviation 15.19
|
0.69 Unit on a scale
Standard Deviation 22.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C14D1
|
0.61 Unit on a scale
Standard Deviation 15.70
|
0.00 Unit on a scale
Standard Deviation 19.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C15D1
|
5.23 Unit on a scale
Standard Deviation 23.45
|
1.85 Unit on a scale
Standard Deviation 30.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia Baseline
|
20.99 Unit on a scale
Standard Deviation 27.16
|
24.79 Unit on a scale
Standard Deviation 26.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C2D1
|
-1.44 Unit on a scale
Standard Deviation 27.47
|
-1.54 Unit on a scale
Standard Deviation 27.55
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C3D1
|
-0.55 Unit on a scale
Standard Deviation 28.14
|
-2.54 Unit on a scale
Standard Deviation 28.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C5D1
|
-2.73 Unit on a scale
Standard Deviation 28.06
|
-4.44 Unit on a scale
Standard Deviation 28.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status Baseline
|
68.83 Unit on a scale
Standard Deviation 18.94
|
66.15 Unit on a scale
Standard Deviation 19.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C2D1
|
0.04 Unit on a scale
Standard Deviation 17.35
|
2.96 Unit on a scale
Standard Deviation 18.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C3D1
|
1.47 Unit on a scale
Standard Deviation 17.15
|
3.68 Unit on a scale
Standard Deviation 20.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C4D1
|
2.61 Unit on a scale
Standard Deviation 18.79
|
4.54 Unit on a scale
Standard Deviation 20.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C5D1
|
0.89 Unit on a scale
Standard Deviation 20.96
|
3.48 Unit on a scale
Standard Deviation 19.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C6D1
|
0.84 Unit on a scale
Standard Deviation 19.32
|
3.94 Unit on a scale
Standard Deviation 20.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C7D1
|
1.94 Unit on a scale
Standard Deviation 18.29
|
2.12 Unit on a scale
Standard Deviation 19.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C8D1
|
0.77 Unit on a scale
Standard Deviation 16.96
|
4.32 Unit on a scale
Standard Deviation 20.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C9D1
|
1.88 Unit on a scale
Standard Deviation 20.91
|
3.32 Unit on a scale
Standard Deviation 20.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C10D1
|
2.65 Unit on a scale
Standard Deviation 20.38
|
3.48 Unit on a scale
Standard Deviation 22.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C11D1
|
1.23 Unit on a scale
Standard Deviation 21.89
|
3.99 Unit on a scale
Standard Deviation 23.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C12D1
|
2.44 Unit on a scale
Standard Deviation 23.44
|
2.63 Unit on a scale
Standard Deviation 22.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C13D1
|
3.47 Unit on a scale
Standard Deviation 24.22
|
3.30 Unit on a scale
Standard Deviation 20.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C14D1
|
1.52 Unit on a scale
Standard Deviation 18.08
|
3.79 Unit on a scale
Standard Deviation 21.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C15D1
|
2.94 Unit on a scale
Standard Deviation 22.78
|
2.08 Unit on a scale
Standard Deviation 21.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C16D1
|
3.65 Unit on a scale
Standard Deviation 22.67
|
5.65 Unit on a scale
Standard Deviation 17.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C17D1
|
6.01 Unit on a scale
Standard Deviation 19.36
|
3.33 Unit on a scale
Standard Deviation 20.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C18D1
|
3.66 Unit on a scale
Standard Deviation 21.33
|
3.97 Unit on a scale
Standard Deviation 31.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C19D1
|
4.17 Unit on a scale
Standard Deviation 17.50
|
10.42 Unit on a scale
Standard Deviation 15.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C20D1
|
1.50 Unit on a scale
Standard Deviation 17.72
|
3.95 Unit on a scale
Standard Deviation 19.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C21D1
|
4.17 Unit on a scale
Standard Deviation 18.53
|
2.92 Unit on a scale
Standard Deviation 18.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C22D1
|
4.03 Unit on a scale
Standard Deviation 19.71
|
9.31 Unit on a scale
Standard Deviation 22.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C23D1
|
4.03 Unit on a scale
Standard Deviation 16.92
|
9.38 Unit on a scale
Standard Deviation 19.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C24D1
|
2.87 Unit on a scale
Standard Deviation 19.32
|
9.72 Unit on a scale
Standard Deviation 21.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C25D1
|
1.79 Unit on a scale
Standard Deviation 18.75
|
10.42 Unit on a scale
Standard Deviation 24.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C26D1
|
4.81 Unit on a scale
Standard Deviation 16.36
|
3.70 Unit on a scale
Standard Deviation 19.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C27D1
|
4.00 Unit on a scale
Standard Deviation 18.18
|
6.67 Unit on a scale
Standard Deviation 11.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C28D1
|
1.98 Unit on a scale
Standard Deviation 18.62
|
5.30 Unit on a scale
Standard Deviation 14.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C29D1
|
3.03 Unit on a scale
Standard Deviation 14.21
|
4.86 Unit on a scale
Standard Deviation 14.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C30D1
|
2.92 Unit on a scale
Standard Deviation 14.12
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C31D1
|
2.08 Unit on a scale
Standard Deviation 19.28
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C32D1
|
2.78 Unit on a scale
Standard Deviation 16.17
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C33D1
|
5.56 Unit on a scale
Standard Deviation 17.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C34D1
|
8.33 Unit on a scale
Standard Deviation 20.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C35D1
|
4.49 Unit on a scale
Standard Deviation 17.88
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C36D1
|
2.78 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C37D1
|
10.61 Unit on a scale
Standard Deviation 15.85
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C38D1
|
8.33 Unit on a scale
Standard Deviation 21.15
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C39D1
|
3.70 Unit on a scale
Standard Deviation 13.89
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status 30 day follow up
|
-8.63 Unit on a scale
Standard Deviation 25.10
|
-10.68 Unit on a scale
Standard Deviation 24.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status 90 day follow up
|
-5.46 Unit on a scale
Standard Deviation 21.19
|
-4.96 Unit on a scale
Standard Deviation 22.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning Baseline
|
83.79 Unit on a scale
Standard Deviation 16.85
|
83.55 Unit on a scale
Standard Deviation 17.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C2D1
|
-0.93 Unit on a scale
Standard Deviation 14.62
|
-0.77 Unit on a scale
Standard Deviation 13.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C3D1
|
-1.76 Unit on a scale
Standard Deviation 14.13
|
-0.07 Unit on a scale
Standard Deviation 14.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C4D1
|
-0.16 Unit on a scale
Standard Deviation 14.25
|
1.07 Unit on a scale
Standard Deviation 15.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C5D1
|
-0.67 Unit on a scale
Standard Deviation 15.32
|
0.24 Unit on a scale
Standard Deviation 16.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C6D1
|
-0.89 Unit on a scale
Standard Deviation 15.47
|
-0.96 Unit on a scale
Standard Deviation 17.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C7D1
|
-1.78 Unit on a scale
Standard Deviation 16.05
|
0.21 Unit on a scale
Standard Deviation 17.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C8D1
|
-3.27 Unit on a scale
Standard Deviation 15.51
|
-1.33 Unit on a scale
Standard Deviation 17.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C9D1
|
-3.20 Unit on a scale
Standard Deviation 17.84
|
-0.84 Unit on a scale
Standard Deviation 18.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C10D1
|
-2.75 Unit on a scale
Standard Deviation 17.13
|
-2.28 Unit on a scale
Standard Deviation 18.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C29D1
|
-3.33 Unit on a scale
Standard Deviation 23.25
|
1.11 Unit on a scale
Standard Deviation 18.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C30D1
|
1.67 Unit on a scale
Standard Deviation 16.17
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C31D1
|
2.00 Unit on a scale
Standard Deviation 16.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C32D1
|
-1.11 Unit on a scale
Standard Deviation 19.97
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C33D1
|
2.22 Unit on a scale
Standard Deviation 18.11
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C34D1
|
6.67 Unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C35D1
|
7.18 Unit on a scale
Standard Deviation 18.55
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C36D1
|
6.67 Unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C37D1
|
7.27 Unit on a scale
Standard Deviation 17.24
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C38D1
|
6.67 Unit on a scale
Standard Deviation 21.55
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C39D1
|
2.96 Unit on a scale
Standard Deviation 10.06
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning 30 day follow up
|
-8.65 Unit on a scale
Standard Deviation 22.36
|
-9.91 Unit on a scale
Standard Deviation 20.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning 90 day follow up
|
-10.16 Unit on a scale
Standard Deviation 20.28
|
-10.63 Unit on a scale
Standard Deviation 22.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning Baseline
|
83.20 Unit on a scale
Standard Deviation 22.52
|
82.23 Unit on a scale
Standard Deviation 23.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C2D1
|
-2.64 Unit on a scale
Standard Deviation 20.52
|
-1.92 Unit on a scale
Standard Deviation 19.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C3D1
|
-2.38 Unit on a scale
Standard Deviation 21.82
|
-2.28 Unit on a scale
Standard Deviation 24.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C4D1
|
-2.37 Unit on a scale
Standard Deviation 20.36
|
-0.79 Unit on a scale
Standard Deviation 24.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C5D1
|
-0.94 Unit on a scale
Standard Deviation 20.73
|
-0.40 Unit on a scale
Standard Deviation 25.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C6D1
|
-3.69 Unit on a scale
Standard Deviation 22.91
|
-3.08 Unit on a scale
Standard Deviation 24.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C7D1
|
-2.08 Unit on a scale
Standard Deviation 20.68
|
-0.79 Unit on a scale
Standard Deviation 23.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C8D1
|
-5.25 Unit on a scale
Standard Deviation 21.57
|
-5.61 Unit on a scale
Standard Deviation 26.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C9D1
|
-5.39 Unit on a scale
Standard Deviation 23.71
|
-2.59 Unit on a scale
Standard Deviation 23.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C10D1
|
-3.92 Unit on a scale
Standard Deviation 24.89
|
-3.59 Unit on a scale
Standard Deviation 26.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C11D1
|
-3.50 Unit on a scale
Standard Deviation 19.31
|
-3.29 Unit on a scale
Standard Deviation 28.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C12D1
|
-3.33 Unit on a scale
Standard Deviation 23.89
|
-2.63 Unit on a scale
Standard Deviation 26.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C13D1
|
-0.83 Unit on a scale
Standard Deviation 24.44
|
-0.35 Unit on a scale
Standard Deviation 27.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C14D1
|
-1.21 Unit on a scale
Standard Deviation 21.48
|
0.76 Unit on a scale
Standard Deviation 21.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C15D1
|
-0.65 Unit on a scale
Standard Deviation 21.07
|
-0.46 Unit on a scale
Standard Deviation 24.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C16D1
|
1.74 Unit on a scale
Standard Deviation 23.12
|
0.00 Unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C17D1
|
3.10 Unit on a scale
Standard Deviation 22.50
|
2.67 Unit on a scale
Standard Deviation 28.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C18D1
|
-3.25 Unit on a scale
Standard Deviation 20.49
|
6.35 Unit on a scale
Standard Deviation 21.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C19D1
|
-0.42 Unit on a scale
Standard Deviation 20.50
|
6.67 Unit on a scale
Standard Deviation 17.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C20D1
|
1.28 Unit on a scale
Standard Deviation 20.37
|
10.53 Unit on a scale
Standard Deviation 22.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C21D1
|
-0.93 Unit on a scale
Standard Deviation 20.29
|
6.67 Unit on a scale
Standard Deviation 23.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C22D1
|
0.54 Unit on a scale
Standard Deviation 19.48
|
8.82 Unit on a scale
Standard Deviation 24.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C23D1
|
0.00 Unit on a scale
Standard Deviation 18.76
|
9.37 Unit on a scale
Standard Deviation 30.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C24D1
|
0.00 Unit on a scale
Standard Deviation 18.37
|
6.94 Unit on a scale
Standard Deviation 27.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C25D1
|
1.79 Unit on a scale
Standard Deviation 20.95
|
8.33 Unit on a scale
Standard Deviation 28.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C26D1
|
-0.64 Unit on a scale
Standard Deviation 20.81
|
-3.70 Unit on a scale
Standard Deviation 27.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C27D1
|
0.00 Unit on a scale
Standard Deviation 17.35
|
-3.33 Unit on a scale
Standard Deviation 23.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C28D1
|
1.59 Unit on a scale
Standard Deviation 18.18
|
-4.55 Unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C29D1
|
-1.52 Unit on a scale
Standard Deviation 24.62
|
2.78 Unit on a scale
Standard Deviation 19.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C30D1
|
3.33 Unit on a scale
Standard Deviation 19.19
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C31D1
|
7.50 Unit on a scale
Standard Deviation 21.27
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C32D1
|
5.56 Unit on a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C33D1
|
6.67 Unit on a scale
Standard Deviation 20.70
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C34D1
|
9.72 Unit on a scale
Standard Deviation 24.06
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C35D1
|
7.69 Unit on a scale
Standard Deviation 21.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C36D1
|
9.72 Unit on a scale
Standard Deviation 21.86
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C37D1
|
12.12 Unit on a scale
Standard Deviation 23.68
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C38D1
|
13.33 Unit on a scale
Standard Deviation 21.94
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C39D1
|
7.41 Unit on a scale
Standard Deviation 22.22
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning 30 day follow up
|
-13.16 Unit on a scale
Standard Deviation 27.95
|
-16.88 Unit on a scale
Standard Deviation 31.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning 90 day follow up
|
-10.93 Unit on a scale
Standard Deviation 27.03
|
-9.49 Unit on a scale
Standard Deviation 30.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning Baseline
|
80.42 Unit on a scale
Standard Deviation 19.13
|
78.79 Unit on a scale
Standard Deviation 19.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C2D1
|
1.32 Unit on a scale
Standard Deviation 15.92
|
4.42 Unit on a scale
Standard Deviation 16.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C3D1
|
0.05 Unit on a scale
Standard Deviation 16.21
|
3.00 Unit on a scale
Standard Deviation 18.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C4D1
|
2.42 Unit on a scale
Standard Deviation 15.52
|
2.51 Unit on a scale
Standard Deviation 19.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C5D1
|
2.46 Unit on a scale
Standard Deviation 17.35
|
3.69 Unit on a scale
Standard Deviation 17.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C6D1
|
1.79 Unit on a scale
Standard Deviation 15.96
|
3.77 Unit on a scale
Standard Deviation 19.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C7D1
|
3.54 Unit on a scale
Standard Deviation 17.90
|
2.12 Unit on a scale
Standard Deviation 21.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C8D1
|
0.77 Unit on a scale
Standard Deviation 19.15
|
2.20 Unit on a scale
Standard Deviation 18.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C9D1
|
2.53 Unit on a scale
Standard Deviation 19.19
|
2.59 Unit on a scale
Standard Deviation 19.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C10D1
|
5.20 Unit on a scale
Standard Deviation 21.13
|
1.79 Unit on a scale
Standard Deviation 20.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C11D1
|
5.35 Unit on a scale
Standard Deviation 20.47
|
2.58 Unit on a scale
Standard Deviation 20.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C12D1
|
6.44 Unit on a scale
Standard Deviation 19.93
|
2.05 Unit on a scale
Standard Deviation 21.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C13D1
|
6.11 Unit on a scale
Standard Deviation 20.40
|
1.91 Unit on a scale
Standard Deviation 21.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C14D1
|
3.94 Unit on a scale
Standard Deviation 19.96
|
-1.33 Unit on a scale
Standard Deviation 18.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C15D1
|
4.25 Unit on a scale
Standard Deviation 16.61
|
-1.85 Unit on a scale
Standard Deviation 21.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C16D1
|
3.99 Unit on a scale
Standard Deviation 15.75
|
-0.27 Unit on a scale
Standard Deviation 23.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C17D1
|
5.81 Unit on a scale
Standard Deviation 15.16
|
5.33 Unit on a scale
Standard Deviation 16.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C18D1
|
2.24 Unit on a scale
Standard Deviation 15.59
|
3.97 Unit on a scale
Standard Deviation 19.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C19D1
|
5.00 Unit on a scale
Standard Deviation 15.07
|
4.58 Unit on a scale
Standard Deviation 13.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C20D1
|
3.85 Unit on a scale
Standard Deviation 15.40
|
1.75 Unit on a scale
Standard Deviation 19.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C21D1
|
3.94 Unit on a scale
Standard Deviation 18.31
|
5.00 Unit on a scale
Standard Deviation 18.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C22D1
|
4.30 Unit on a scale
Standard Deviation 14.25
|
2.45 Unit on a scale
Standard Deviation 18.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C23D1
|
2.42 Unit on a scale
Standard Deviation 11.42
|
3.65 Unit on a scale
Standard Deviation 23.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C24D1
|
2.59 Unit on a scale
Standard Deviation 14.79
|
-0.69 Unit on a scale
Standard Deviation 23.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C25D1
|
2.68 Unit on a scale
Standard Deviation 16.36
|
-0.69 Unit on a scale
Standard Deviation 20.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C26D1
|
4.17 Unit on a scale
Standard Deviation 16.37
|
-3.70 Unit on a scale
Standard Deviation 18.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C27D1
|
3.00 Unit on a scale
Standard Deviation 18.30
|
-5.83 Unit on a scale
Standard Deviation 19.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C28D1
|
0.79 Unit on a scale
Standard Deviation 19.53
|
-3.79 Unit on a scale
Standard Deviation 19.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C29D1
|
2.65 Unit on a scale
Standard Deviation 17.33
|
-3.47 Unit on a scale
Standard Deviation 27.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C30D1
|
-0.42 Unit on a scale
Standard Deviation 17.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C31D1
|
1.25 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C32D1
|
3.70 Unit on a scale
Standard Deviation 16.96
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C33D1
|
5.56 Unit on a scale
Standard Deviation 18.81
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C34D1
|
11.81 Unit on a scale
Standard Deviation 12.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C36D1
|
-2.78 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C35D1
|
5.13 Unit on a scale
Standard Deviation 15.79
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C36D1
|
9.03 Unit on a scale
Standard Deviation 15.27
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C37D1
|
11.36 Unit on a scale
Standard Deviation 15.93
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C38D1
|
10.83 Unit on a scale
Standard Deviation 14.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C39D1
|
-1.85 Unit on a scale
Standard Deviation 21.15
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning 30 day follow up
|
-5.99 Unit on a scale
Standard Deviation 26.01
|
-5.02 Unit on a scale
Standard Deviation 24.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning 90 day follow up
|
-4.37 Unit on a scale
Standard Deviation 15.34
|
0.21 Unit on a scale
Standard Deviation 21.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning Baseline
|
90.95 Unit on a scale
Standard Deviation 14.86
|
87.81 Unit on a scale
Standard Deviation 18.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C15D1
|
-0.98 Unit on a scale
Standard Deviation 15.06
|
-1.39 Unit on a scale
Standard Deviation 19.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C16D1
|
1.39 Unit on a scale
Standard Deviation 16.43
|
-2.69 Unit on a scale
Standard Deviation 20.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C17D1
|
0.78 Unit on a scale
Standard Deviation 12.57
|
2.67 Unit on a scale
Standard Deviation 14.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C18D1
|
1.63 Unit on a scale
Standard Deviation 13.85
|
2.38 Unit on a scale
Standard Deviation 16.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C19D1
|
0.42 Unit on a scale
Standard Deviation 16.66
|
3.33 Unit on a scale
Standard Deviation 11.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C20D1
|
0.85 Unit on a scale
Standard Deviation 17.91
|
1.75 Unit on a scale
Standard Deviation 21.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C21D1
|
0.93 Unit on a scale
Standard Deviation 19.08
|
6.67 Unit on a scale
Standard Deviation 18.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C22D1
|
2.69 Unit on a scale
Standard Deviation 18.31
|
4.90 Unit on a scale
Standard Deviation 20.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C23D1
|
1.61 Unit on a scale
Standard Deviation 17.93
|
6.25 Unit on a scale
Standard Deviation 17.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C24D1
|
2.30 Unit on a scale
Standard Deviation 18.75
|
0.00 Unit on a scale
Standard Deviation 15.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C25D1
|
1.79 Unit on a scale
Standard Deviation 18.89
|
1.39 Unit on a scale
Standard Deviation 19.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C26D1
|
1.92 Unit on a scale
Standard Deviation 19.05
|
0.00 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C27D1
|
2.67 Unit on a scale
Standard Deviation 17.13
|
-1.67 Unit on a scale
Standard Deviation 14.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C28D1
|
3.17 Unit on a scale
Standard Deviation 18.72
|
-3.03 Unit on a scale
Standard Deviation 14.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C29D1
|
0.76 Unit on a scale
Standard Deviation 21.50
|
0.00 Unit on a scale
Standard Deviation 14.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C30D1
|
0.00 Unit on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C31D1
|
0.00 Unit on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C32D1
|
2.78 Unit on a scale
Standard Deviation 21.58
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C33D1
|
5.56 Unit on a scale
Standard Deviation 20.57
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C34D1
|
6.94 Unit on a scale
Standard Deviation 21.86
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C35D1
|
6.41 Unit on a scale
Standard Deviation 24.09
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C36D1
|
8.33 Unit on a scale
Standard Deviation 19.46
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C37D1
|
9.09 Unit on a scale
Standard Deviation 21.56
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C38D1
|
8.33 Unit on a scale
Standard Deviation 23.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C39D1
|
1.85 Unit on a scale
Standard Deviation 13.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C2D1
|
-0.24 Unit on a scale
Standard Deviation 13.36
|
0.54 Unit on a scale
Standard Deviation 15.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning 30 day follow up
|
-2.63 Unit on a scale
Standard Deviation 18.84
|
-4.27 Unit on a scale
Standard Deviation 20.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C3D1
|
-1.47 Unit on a scale
Standard Deviation 14.90
|
0.51 Unit on a scale
Standard Deviation 15.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning 90 day follow up
|
-7.65 Unit on a scale
Standard Deviation 17.37
|
-2.32 Unit on a scale
Standard Deviation 20.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning Baseline
|
79.42 Unit on a scale
Standard Deviation 22.16
|
79.55 Unit on a scale
Standard Deviation 23.48
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C2D1
|
0.88 Unit on a scale
Standard Deviation 21.31
|
-1.61 Unit on a scale
Standard Deviation 20.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C3D1
|
-1.47 Unit on a scale
Standard Deviation 23.65
|
-1.44 Unit on a scale
Standard Deviation 22.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C4D1
|
0.79 Unit on a scale
Standard Deviation 23.77
|
1.97 Unit on a scale
Standard Deviation 21.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C4D1
|
-0.59 Unit on a scale
Standard Deviation 13.47
|
1.87 Unit on a scale
Standard Deviation 15.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C5D1
|
2.20 Unit on a scale
Standard Deviation 25.58
|
0.20 Unit on a scale
Standard Deviation 22.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C6D1
|
-0.78 Unit on a scale
Standard Deviation 25.29
|
-1.37 Unit on a scale
Standard Deviation 22.53
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C7D1
|
-0.97 Unit on a scale
Standard Deviation 26.22
|
-0.66 Unit on a scale
Standard Deviation 24.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C8D1
|
-0.93 Unit on a scale
Standard Deviation 27.33
|
-2.12 Unit on a scale
Standard Deviation 23.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C9D1
|
-0.98 Unit on a scale
Standard Deviation 24.01
|
-0.32 Unit on a scale
Standard Deviation 24.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C10D1
|
2.55 Unit on a scale
Standard Deviation 25.39
|
-0.84 Unit on a scale
Standard Deviation 27.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C11D1
|
3.29 Unit on a scale
Standard Deviation 23.19
|
-2.58 Unit on a scale
Standard Deviation 25.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C12D1
|
3.33 Unit on a scale
Standard Deviation 23.09
|
-1.75 Unit on a scale
Standard Deviation 28.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C13D1
|
3.89 Unit on a scale
Standard Deviation 24.43
|
-0.35 Unit on a scale
Standard Deviation 23.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C14D1
|
2.12 Unit on a scale
Standard Deviation 20.80
|
1.52 Unit on a scale
Standard Deviation 24.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C15D1
|
1.63 Unit on a scale
Standard Deviation 22.42
|
-2.78 Unit on a scale
Standard Deviation 23.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C16D1
|
4.86 Unit on a scale
Standard Deviation 20.03
|
1.08 Unit on a scale
Standard Deviation 19.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C17D1
|
5.43 Unit on a scale
Standard Deviation 18.45
|
3.33 Unit on a scale
Standard Deviation 15.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C18D1
|
0.81 Unit on a scale
Standard Deviation 22.96
|
2.38 Unit on a scale
Standard Deviation 16.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C19D1
|
5.42 Unit on a scale
Standard Deviation 19.02
|
8.33 Unit on a scale
Standard Deviation 20.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C20D1
|
2.56 Unit on a scale
Standard Deviation 21.81
|
7.02 Unit on a scale
Standard Deviation 20.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C21D1
|
2.31 Unit on a scale
Standard Deviation 21.88
|
4.17 Unit on a scale
Standard Deviation 17.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C22D1
|
5.91 Unit on a scale
Standard Deviation 21.32
|
4.90 Unit on a scale
Standard Deviation 15.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C23D1
|
4.30 Unit on a scale
Standard Deviation 24.33
|
8.33 Unit on a scale
Standard Deviation 18.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C24D1
|
4.02 Unit on a scale
Standard Deviation 23.84
|
-1.39 Unit on a scale
Standard Deviation 15.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C25D1
|
4.76 Unit on a scale
Standard Deviation 21.21
|
-2.78 Unit on a scale
Standard Deviation 15.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C26D1
|
5.77 Unit on a scale
Standard Deviation 23.54
|
3.70 Unit on a scale
Standard Deviation 24.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C27D1
|
4.00 Unit on a scale
Standard Deviation 25.59
|
5.00 Unit on a scale
Standard Deviation 15.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C5D1
|
-1.89 Unit on a scale
Standard Deviation 15.80
|
2.22 Unit on a scale
Standard Deviation 15.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C28D1
|
4.76 Unit on a scale
Standard Deviation 29.88
|
3.03 Unit on a scale
Standard Deviation 16.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C29D1
|
3.03 Unit on a scale
Standard Deviation 26.55
|
0.00 Unit on a scale
Standard Deviation 21.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C30D1
|
3.33 Unit on a scale
Standard Deviation 28.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C6D1
|
-1.45 Unit on a scale
Standard Deviation 14.87
|
0.91 Unit on a scale
Standard Deviation 16.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C31D1
|
3.33 Unit on a scale
Standard Deviation 27.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C32D1
|
0.93 Unit on a scale
Standard Deviation 29.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C33D1
|
3.33 Unit on a scale
Standard Deviation 34.04
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C34D1
|
5.56 Unit on a scale
Standard Deviation 35.06
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C35D1
|
2.56 Unit on a scale
Standard Deviation 32.52
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C36D1
|
5.56 Unit on a scale
Standard Deviation 33.58
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C37D1
|
6.06 Unit on a scale
Standard Deviation 36.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C38D1
|
13.33 Unit on a scale
Standard Deviation 31.23
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C39D1
|
0.00 Unit on a scale
Standard Deviation 33.33
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning 30 day follow up
|
-4.09 Unit on a scale
Standard Deviation 28.22
|
-12.82 Unit on a scale
Standard Deviation 26.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning 90 day follow up
|
0.27 Unit on a scale
Standard Deviation 24.05
|
-8.23 Unit on a scale
Standard Deviation 26.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue Baseline
|
26.29 Unit on a scale
Standard Deviation 22.00
|
27.55 Unit on a scale
Standard Deviation 22.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C2D1
|
1.66 Unit on a scale
Standard Deviation 19.69
|
0.15 Unit on a scale
Standard Deviation 19.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C7D1
|
0.00 Unit on a scale
Standard Deviation 16.31
|
-1.19 Unit on a scale
Standard Deviation 17.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C3D1
|
3.17 Unit on a scale
Standard Deviation 21.71
|
0.96 Unit on a scale
Standard Deviation 21.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C4D1
|
1.05 Unit on a scale
Standard Deviation 21.93
|
-0.46 Unit on a scale
Standard Deviation 22.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C5D1
|
1.40 Unit on a scale
Standard Deviation 23.21
|
-0.81 Unit on a scale
Standard Deviation 23.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C8D1
|
-2.16 Unit on a scale
Standard Deviation 15.13
|
0.15 Unit on a scale
Standard Deviation 18.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C6D1
|
2.83 Unit on a scale
Standard Deviation 21.07
|
0.91 Unit on a scale
Standard Deviation 25.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C7D1
|
1.11 Unit on a scale
Standard Deviation 20.99
|
-1.06 Unit on a scale
Standard Deviation 23.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C8D1
|
4.94 Unit on a scale
Standard Deviation 20.34
|
0.10 Unit on a scale
Standard Deviation 23.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C9D1
|
1.96 Unit on a scale
Standard Deviation 24.94
|
-0.86 Unit on a scale
Standard Deviation 23.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C10D1
|
1.57 Unit on a scale
Standard Deviation 25.67
|
-0.42 Unit on a scale
Standard Deviation 24.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C11D1
|
-0.14 Unit on a scale
Standard Deviation 22.53
|
-0.31 Unit on a scale
Standard Deviation 24.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C12D1
|
-0.89 Unit on a scale
Standard Deviation 24.08
|
0.00 Unit on a scale
Standard Deviation 23.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C13D1
|
-3.70 Unit on a scale
Standard Deviation 25.03
|
0.00 Unit on a scale
Standard Deviation 20.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C14D1
|
-2.22 Unit on a scale
Standard Deviation 19.99
|
-0.76 Unit on a scale
Standard Deviation 19.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C15D1
|
-3.27 Unit on a scale
Standard Deviation 21.12
|
-0.62 Unit on a scale
Standard Deviation 17.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C16D1
|
-4.63 Unit on a scale
Standard Deviation 21.60
|
-2.15 Unit on a scale
Standard Deviation 17.55
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C17D1
|
-2.07 Unit on a scale
Standard Deviation 18.98
|
-1.78 Unit on a scale
Standard Deviation 18.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C18D1
|
-0.81 Unit on a scale
Standard Deviation 17.10
|
-7.94 Unit on a scale
Standard Deviation 17.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C19D1
|
-1.11 Unit on a scale
Standard Deviation 17.93
|
-4.44 Unit on a scale
Standard Deviation 15.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C20D1
|
0.57 Unit on a scale
Standard Deviation 16.51
|
-4.68 Unit on a scale
Standard Deviation 18.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C21D1
|
1.23 Unit on a scale
Standard Deviation 16.75
|
-3.33 Unit on a scale
Standard Deviation 18.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C22D1
|
-2.87 Unit on a scale
Standard Deviation 19.02
|
-3.27 Unit on a scale
Standard Deviation 18.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C23D1
|
-1.43 Unit on a scale
Standard Deviation 17.62
|
-4.17 Unit on a scale
Standard Deviation 22.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C24D1
|
-1.15 Unit on a scale
Standard Deviation 17.65
|
-3.70 Unit on a scale
Standard Deviation 19.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C25D1
|
-3.17 Unit on a scale
Standard Deviation 18.36
|
-0.93 Unit on a scale
Standard Deviation 17.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C26D1
|
-1.71 Unit on a scale
Standard Deviation 21.70
|
0.00 Unit on a scale
Standard Deviation 11.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C27D1
|
-3.11 Unit on a scale
Standard Deviation 14.17
|
2.22 Unit on a scale
Standard Deviation 15.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C28D1
|
-2.65 Unit on a scale
Standard Deviation 16.06
|
8.08 Unit on a scale
Standard Deviation 13.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C29D1
|
-3.54 Unit on a scale
Standard Deviation 14.70
|
5.56 Unit on a scale
Standard Deviation 18.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C30D1
|
-2.78 Unit on a scale
Standard Deviation 13.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C31D1
|
-2.22 Unit on a scale
Standard Deviation 17.14
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C32D1
|
-5.56 Unit on a scale
Standard Deviation 18.77
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C33D1
|
-8.15 Unit on a scale
Standard Deviation 19.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C34D1
|
-12.04 Unit on a scale
Standard Deviation 18.63
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C35D1
|
-10.26 Unit on a scale
Standard Deviation 12.39
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C36D1
|
-12.04 Unit on a scale
Standard Deviation 10.00
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C37D1
|
-12.12 Unit on a scale
Standard Deviation 14.45
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C38D1
|
-12.22 Unit on a scale
Standard Deviation 21.24
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C39D1
|
-7.41 Unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue 30 day follow up
|
11.50 Unit on a scale
Standard Deviation 23.09
|
13.68 Unit on a scale
Standard Deviation 27.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue 90 day follow up
|
11.84 Unit on a scale
Standard Deviation 21.55
|
7.31 Unit on a scale
Standard Deviation 22.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting Baseline
|
10.49 Unit on a scale
Standard Deviation 18.08
|
15.08 Unit on a scale
Standard Deviation 23.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C2D1
|
6.41 Unit on a scale
Standard Deviation 19.77
|
-0.92 Unit on a scale
Standard Deviation 20.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C3D1
|
5.86 Unit on a scale
Standard Deviation 19.88
|
0.17 Unit on a scale
Standard Deviation 22.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C4D1
|
4.73 Unit on a scale
Standard Deviation 20.67
|
-2.76 Unit on a scale
Standard Deviation 22.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C5D1
|
4.93 Unit on a scale
Standard Deviation 21.01
|
-3.74 Unit on a scale
Standard Deviation 25.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C6D1
|
6.04 Unit on a scale
Standard Deviation 20.25
|
-1.60 Unit on a scale
Standard Deviation 24.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C7D1
|
1.25 Unit on a scale
Standard Deviation 19.94
|
-2.91 Unit on a scale
Standard Deviation 24.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C8D1
|
3.09 Unit on a scale
Standard Deviation 20.14
|
-6.97 Unit on a scale
Standard Deviation 23.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C9D1
|
1.80 Unit on a scale
Standard Deviation 20.83
|
-6.15 Unit on a scale
Standard Deviation 20.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C10D1
|
0.39 Unit on a scale
Standard Deviation 20.25
|
-7.17 Unit on a scale
Standard Deviation 24.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C11D1
|
-1.65 Unit on a scale
Standard Deviation 19.65
|
-6.81 Unit on a scale
Standard Deviation 24.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C9D1
|
-1.96 Unit on a scale
Standard Deviation 14.70
|
0.97 Unit on a scale
Standard Deviation 18.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C12D1
|
-1.11 Unit on a scale
Standard Deviation 19.82
|
-2.34 Unit on a scale
Standard Deviation 25.48
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C13D1
|
-3.33 Unit on a scale
Standard Deviation 20.54
|
-7.99 Unit on a scale
Standard Deviation 23.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C14D1
|
-1.21 Unit on a scale
Standard Deviation 19.73
|
-4.17 Unit on a scale
Standard Deviation 21.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C15D1
|
-2.94 Unit on a scale
Standard Deviation 18.17
|
-5.56 Unit on a scale
Standard Deviation 20.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C16D1
|
-1.04 Unit on a scale
Standard Deviation 20.17
|
-5.91 Unit on a scale
Standard Deviation 20.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C17D1
|
-1.94 Unit on a scale
Standard Deviation 18.62
|
2.67 Unit on a scale
Standard Deviation 13.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C18D1
|
0.81 Unit on a scale
Standard Deviation 20.40
|
-4.76 Unit on a scale
Standard Deviation 11.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C19D1
|
0.00 Unit on a scale
Standard Deviation 20.32
|
-4.17 Unit on a scale
Standard Deviation 11.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C20D1
|
-0.85 Unit on a scale
Standard Deviation 19.10
|
-4.39 Unit on a scale
Standard Deviation 12.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C21D1
|
0.00 Unit on a scale
Standard Deviation 19.92
|
-3.33 Unit on a scale
Standard Deviation 11.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C22D1
|
-2.69 Unit on a scale
Standard Deviation 20.23
|
-5.88 Unit on a scale
Standard Deviation 13.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C23D1
|
-3.76 Unit on a scale
Standard Deviation 21.39
|
-7.29 Unit on a scale
Standard Deviation 12.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C24D1
|
-3.45 Unit on a scale
Standard Deviation 20.11
|
-1.39 Unit on a scale
Standard Deviation 11.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C25D1
|
-4.17 Unit on a scale
Standard Deviation 20.60
|
-6.94 Unit on a scale
Standard Deviation 13.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C26D1
|
-4.49 Unit on a scale
Standard Deviation 20.85
|
-1.85 Unit on a scale
Standard Deviation 24.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C27D1
|
-4.67 Unit on a scale
Standard Deviation 20.14
|
-5.00 Unit on a scale
Standard Deviation 15.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C28D1
|
-0.79 Unit on a scale
Standard Deviation 23.85
|
-3.03 Unit on a scale
Standard Deviation 14.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C29D1
|
-3.79 Unit on a scale
Standard Deviation 21.78
|
-9.72 Unit on a scale
Standard Deviation 13.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C30D1
|
-3.33 Unit on a scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C31D1
|
-4.17 Unit on a scale
Standard Deviation 23.49
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C32D1
|
-2.78 Unit on a scale
Standard Deviation 25.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C33D1
|
-8.89 Unit on a scale
Standard Deviation 21.70
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C34D1
|
-8.33 Unit on a scale
Standard Deviation 25.13
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C35D1
|
-6.41 Unit on a scale
Standard Deviation 25.04
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C36D1
|
-6.94 Unit on a scale
Standard Deviation 25.08
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C37D1
|
-9.09 Unit on a scale
Standard Deviation 20.23
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C38D1
|
-6.67 Unit on a scale
Standard Deviation 14.05
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C39D1
|
-5.56 Unit on a scale
Standard Deviation 8.33
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting 30 day follow up
|
4.39 Unit on a scale
Standard Deviation 19.80
|
0.21 Unit on a scale
Standard Deviation 24.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting 90 day follow up
|
7.38 Unit on a scale
Standard Deviation 21.20
|
-1.05 Unit on a scale
Standard Deviation 26.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain Baseline
|
21.67 Unit on a scale
Standard Deviation 22.14
|
24.10 Unit on a scale
Standard Deviation 23.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C2D1
|
-4.17 Unit on a scale
Standard Deviation 22.43
|
-4.61 Unit on a scale
Standard Deviation 20.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C3D1
|
-5.40 Unit on a scale
Standard Deviation 21.16
|
-3.38 Unit on a scale
Standard Deviation 22.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C4D1
|
-7.10 Unit on a scale
Standard Deviation 21.18
|
-7.40 Unit on a scale
Standard Deviation 22.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C5D1
|
-4.82 Unit on a scale
Standard Deviation 22.06
|
-6.26 Unit on a scale
Standard Deviation 26.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C6D1
|
-3.13 Unit on a scale
Standard Deviation 19.79
|
-6.85 Unit on a scale
Standard Deviation 26.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C7D1
|
-6.39 Unit on a scale
Standard Deviation 22.16
|
-7.67 Unit on a scale
Standard Deviation 22.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C8D1
|
-4.17 Unit on a scale
Standard Deviation 22.22
|
-5.61 Unit on a scale
Standard Deviation 24.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C9D1
|
-5.07 Unit on a scale
Standard Deviation 21.72
|
-8.09 Unit on a scale
Standard Deviation 24.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C10D1
|
-4.12 Unit on a scale
Standard Deviation 22.11
|
-6.33 Unit on a scale
Standard Deviation 25.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C11D1
|
-6.38 Unit on a scale
Standard Deviation 21.01
|
-6.34 Unit on a scale
Standard Deviation 26.78
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C12D1
|
-4.44 Unit on a scale
Standard Deviation 22.48
|
-7.02 Unit on a scale
Standard Deviation 24.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C13D1
|
-6.39 Unit on a scale
Standard Deviation 23.98
|
-7.64 Unit on a scale
Standard Deviation 24.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C14D1
|
-5.76 Unit on a scale
Standard Deviation 22.27
|
-6.06 Unit on a scale
Standard Deviation 24.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C10D1
|
-0.59 Unit on a scale
Standard Deviation 17.15
|
-0.42 Unit on a scale
Standard Deviation 19.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C16D1
|
-6.25 Unit on a scale
Standard Deviation 19.64
|
-6.45 Unit on a scale
Standard Deviation 23.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C17D1
|
-5.04 Unit on a scale
Standard Deviation 19.43
|
-7.33 Unit on a scale
Standard Deviation 25.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C18D1
|
-1.63 Unit on a scale
Standard Deviation 18.18
|
-11.90 Unit on a scale
Standard Deviation 27.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C19D1
|
-2.50 Unit on a scale
Standard Deviation 18.32
|
-7.50 Unit on a scale
Standard Deviation 26.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C20D1
|
-0.85 Unit on a scale
Standard Deviation 16.64
|
-8.77 Unit on a scale
Standard Deviation 30.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C21D1
|
-2.31 Unit on a scale
Standard Deviation 19.58
|
-11.67 Unit on a scale
Standard Deviation 29.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C22D1
|
-2.69 Unit on a scale
Standard Deviation 18.31
|
-12.75 Unit on a scale
Standard Deviation 30.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C23D1
|
-3.76 Unit on a scale
Standard Deviation 18.11
|
-15.63 Unit on a scale
Standard Deviation 30.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C24D1
|
-4.02 Unit on a scale
Standard Deviation 18.18
|
-8.33 Unit on a scale
Standard Deviation 29.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C25D1
|
-1.19 Unit on a scale
Standard Deviation 21.24
|
-11.11 Unit on a scale
Standard Deviation 29.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C26D1
|
-3.85 Unit on a scale
Standard Deviation 19.61
|
-9.26 Unit on a scale
Standard Deviation 18.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C27D1
|
-4.00 Unit on a scale
Standard Deviation 20.57
|
-6.67 Unit on a scale
Standard Deviation 23.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C28D1
|
-4.76 Unit on a scale
Standard Deviation 21.18
|
-3.03 Unit on a scale
Standard Deviation 19.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C29D1
|
-3.79 Unit on a scale
Standard Deviation 21.16
|
-11.11 Unit on a scale
Standard Deviation 23.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C30D1
|
-6.67 Unit on a scale
Standard Deviation 19.79
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C31D1
|
-6.67 Unit on a scale
Standard Deviation 21.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C32D1
|
-6.48 Unit on a scale
Standard Deviation 22.97
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C33D1
|
-10.00 Unit on a scale
Standard Deviation 22.54
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C34D1
|
-13.89 Unit on a scale
Standard Deviation 21.12
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C35D1
|
-10.26 Unit on a scale
Standard Deviation 22.09
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C36D1
|
-12.50 Unit on a scale
Standard Deviation 21.47
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C37D1
|
-12.12 Unit on a scale
Standard Deviation 23.68
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C38D1
|
-5.00 Unit on a scale
Standard Deviation 24.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C39D1
|
-9.26 Unit on a scale
Standard Deviation 16.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain 30 day follow up
|
4.97 Unit on a scale
Standard Deviation 27.45
|
8.76 Unit on a scale
Standard Deviation 26.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain 90 day follow up
|
4.37 Unit on a scale
Standard Deviation 22.55
|
2.11 Unit on a scale
Standard Deviation 22.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea Baseline
|
9.74 Unit on a scale
Standard Deviation 17.96
|
10.88 Unit on a scale
Standard Deviation 19.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C2D1
|
2.24 Unit on a scale
Standard Deviation 15.89
|
-0.77 Unit on a scale
Standard Deviation 17.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C3D1
|
-0.37 Unit on a scale
Standard Deviation 16.80
|
0.51 Unit on a scale
Standard Deviation 22.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C4D1
|
0.00 Unit on a scale
Standard Deviation 16.67
|
-0.39 Unit on a scale
Standard Deviation 23.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C5D1
|
-0.42 Unit on a scale
Standard Deviation 19.48
|
-2.22 Unit on a scale
Standard Deviation 23.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C6D1
|
1.12 Unit on a scale
Standard Deviation 19.54
|
0.00 Unit on a scale
Standard Deviation 21.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C7D1
|
1.67 Unit on a scale
Standard Deviation 20.20
|
-0.53 Unit on a scale
Standard Deviation 22.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C8D1
|
1.85 Unit on a scale
Standard Deviation 19.25
|
2.12 Unit on a scale
Standard Deviation 23.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C9D1
|
0.65 Unit on a scale
Standard Deviation 18.15
|
-2.27 Unit on a scale
Standard Deviation 20.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C11D1
|
-1.23 Unit on a scale
Standard Deviation 14.86
|
-1.41 Unit on a scale
Standard Deviation 18.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C10D1
|
1.18 Unit on a scale
Standard Deviation 20.86
|
-0.42 Unit on a scale
Standard Deviation 24.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C11D1
|
0.41 Unit on a scale
Standard Deviation 20.07
|
-3.29 Unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C12D1
|
-1.33 Unit on a scale
Standard Deviation 20.09
|
-2.92 Unit on a scale
Standard Deviation 19.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C13D1
|
-0.56 Unit on a scale
Standard Deviation 23.36
|
-2.78 Unit on a scale
Standard Deviation 21.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C14D1
|
-0.61 Unit on a scale
Standard Deviation 20.78
|
-4.55 Unit on a scale
Standard Deviation 19.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C15D1
|
0.00 Unit on a scale
Standard Deviation 17.64
|
-4.63 Unit on a scale
Standard Deviation 16.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C16D1
|
-0.69 Unit on a scale
Standard Deviation 16.11
|
-3.23 Unit on a scale
Standard Deviation 21.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C17D1
|
0.00 Unit on a scale
Standard Deviation 16.27
|
-6.67 Unit on a scale
Standard Deviation 21.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C18D1
|
1.63 Unit on a scale
Standard Deviation 16.59
|
-9.52 Unit on a scale
Standard Deviation 18.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C19D1
|
0.00 Unit on a scale
Standard Deviation 16.88
|
-11.67 Unit on a scale
Standard Deviation 19.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C20D1
|
2.56 Unit on a scale
Standard Deviation 19.32
|
-10.53 Unit on a scale
Standard Deviation 22.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C21D1
|
0.93 Unit on a scale
Standard Deviation 16.88
|
-10.00 Unit on a scale
Standard Deviation 19.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C22D1
|
1.08 Unit on a scale
Standard Deviation 20.15
|
-9.80 Unit on a scale
Standard Deviation 22.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C23D1
|
0.00 Unit on a scale
Standard Deviation 14.91
|
-8.33 Unit on a scale
Standard Deviation 22.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C24D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C25D1
|
0.00 Unit on a scale
Standard Deviation 20.29
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C26D1
|
-3.85 Unit on a scale
Standard Deviation 14.38
|
-7.41 Unit on a scale
Standard Deviation 14.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C27D1
|
2.67 Unit on a scale
Standard Deviation 16.44
|
-6.67 Unit on a scale
Standard Deviation 14.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C28D1
|
-1.59 Unit on a scale
Standard Deviation 16.59
|
-9.09 Unit on a scale
Standard Deviation 21.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C29D1
|
7.58 Unit on a scale
Standard Deviation 27.08
|
-11.11 Unit on a scale
Standard Deviation 21.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C30D1
|
0.00 Unit on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C31D1
|
-1.67 Unit on a scale
Standard Deviation 22.88
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C32D1
|
0.00 Unit on a scale
Standard Deviation 22.87
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C33D1
|
2.22 Unit on a scale
Standard Deviation 23.46
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C34D1
|
-8.33 Unit on a scale
Standard Deviation 20.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C35D1
|
-2.56 Unit on a scale
Standard Deviation 21.35
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C36D1
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C37D1
|
-9.09 Unit on a scale
Standard Deviation 21.56
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C38D1
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C39D1
|
-3.70 Unit on a scale
Standard Deviation 20.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea 30 day follow up
|
3.51 Unit on a scale
Standard Deviation 16.29
|
4.27 Unit on a scale
Standard Deviation 23.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea 90 day follow up
|
2.73 Unit on a scale
Standard Deviation 15.27
|
2.53 Unit on a scale
Standard Deviation 24.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C14D1
|
-12.12 Unit on a scale
Standard Deviation 31.01
|
-11.36 Unit on a scale
Standard Deviation 30.45
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C6D1
|
-5.82 Unit on a scale
Standard Deviation 26.77
|
-4.34 Unit on a scale
Standard Deviation 29.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C7D1
|
-7.78 Unit on a scale
Standard Deviation 26.19
|
-2.12 Unit on a scale
Standard Deviation 32.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C8D1
|
-4.63 Unit on a scale
Standard Deviation 27.14
|
-3.03 Unit on a scale
Standard Deviation 31.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C9D1
|
-4.25 Unit on a scale
Standard Deviation 22.82
|
-5.50 Unit on a scale
Standard Deviation 29.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C10D1
|
-6.27 Unit on a scale
Standard Deviation 26.97
|
-7.17 Unit on a scale
Standard Deviation 30.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C11D1
|
-4.94 Unit on a scale
Standard Deviation 28.44
|
-3.29 Unit on a scale
Standard Deviation 33.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C12D1
|
-6.22 Unit on a scale
Standard Deviation 25.52
|
-1.17 Unit on a scale
Standard Deviation 26.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C14D1
|
-6.06 Unit on a scale
Standard Deviation 25.73
|
-2.27 Unit on a scale
Standard Deviation 28.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C15D1
|
-4.58 Unit on a scale
Standard Deviation 27.50
|
-3.70 Unit on a scale
Standard Deviation 32.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C16D1
|
-2.78 Unit on a scale
Standard Deviation 26.48
|
-2.15 Unit on a scale
Standard Deviation 33.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C17D1
|
-3.88 Unit on a scale
Standard Deviation 27.42
|
-1.33 Unit on a scale
Standard Deviation 26.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C18D1
|
-5.69 Unit on a scale
Standard Deviation 25.71
|
-6.35 Unit on a scale
Standard Deviation 29.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C19D1
|
-5.83 Unit on a scale
Standard Deviation 23.74
|
-6.67 Unit on a scale
Standard Deviation 17.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C20D1
|
0.00 Unit on a scale
Standard Deviation 31.53
|
-7.02 Unit on a scale
Standard Deviation 26.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C21D1
|
0.00 Unit on a scale
Standard Deviation 26.43
|
-5.00 Unit on a scale
Standard Deviation 31.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C22D1
|
-2.15 Unit on a scale
Standard Deviation 32.13
|
1.96 Unit on a scale
Standard Deviation 24.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C23D1
|
-3.23 Unit on a scale
Standard Deviation 27.70
|
0.00 Unit on a scale
Standard Deviation 34.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C24D1
|
-3.45 Unit on a scale
Standard Deviation 22.44
|
5.56 Unit on a scale
Standard Deviation 31.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C25D1
|
-3.57 Unit on a scale
Standard Deviation 24.58
|
0.00 Unit on a scale
Standard Deviation 24.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C26D1
|
-5.13 Unit on a scale
Standard Deviation 26.15
|
7.41 Unit on a scale
Standard Deviation 14.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C27D1
|
-6.67 Unit on a scale
Standard Deviation 25.46
|
10.00 Unit on a scale
Standard Deviation 22.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C28D1
|
-4.76 Unit on a scale
Standard Deviation 19.11
|
12.12 Unit on a scale
Standard Deviation 22.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C29D1
|
0.00 Unit on a scale
Standard Deviation 20.57
|
5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C30D1
|
-3.33 Unit on a scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C31D1
|
0.00 Unit on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C32D1
|
1.85 Unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C33D1
|
-6.67 Unit on a scale
Standard Deviation 18.69
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C34D1
|
-8.33 Unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C35D1
|
-7.69 Unit on a scale
Standard Deviation 14.62
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C36D1
|
-8.33 Unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C37D1
|
-12.12 Unit on a scale
Standard Deviation 16.82
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C38D1
|
-6.67 Unit on a scale
Standard Deviation 14.05
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C39D1
|
-3.70 Unit on a scale
Standard Deviation 11.11
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation 30 day follow up
|
-2.34 Unit on a scale
Standard Deviation 30.12
|
4.70 Unit on a scale
Standard Deviation 28.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation 90 day follow up
|
1.09 Unit on a scale
Standard Deviation 27.19
|
5.91 Unit on a scale
Standard Deviation 31.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea Baseline
|
8.09 Unit on a scale
Standard Deviation 16.41
|
7.71 Unit on a scale
Standard Deviation 15.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C2D1
|
2.56 Unit on a scale
Standard Deviation 20.56
|
5.68 Unit on a scale
Standard Deviation 22.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C3D1
|
2.93 Unit on a scale
Standard Deviation 21.40
|
4.06 Unit on a scale
Standard Deviation 20.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C4D1
|
1.38 Unit on a scale
Standard Deviation 21.00
|
3.94 Unit on a scale
Standard Deviation 22.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C5D1
|
1.47 Unit on a scale
Standard Deviation 20.66
|
4.44 Unit on a scale
Standard Deviation 20.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C6D1
|
2.91 Unit on a scale
Standard Deviation 24.79
|
3.65 Unit on a scale
Standard Deviation 21.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C7D1
|
1.94 Unit on a scale
Standard Deviation 24.17
|
5.29 Unit on a scale
Standard Deviation 19.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C8D1
|
1.23 Unit on a scale
Standard Deviation 21.82
|
2.12 Unit on a scale
Standard Deviation 18.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C9D1
|
1.31 Unit on a scale
Standard Deviation 23.42
|
0.65 Unit on a scale
Standard Deviation 19.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C10D1
|
1.18 Unit on a scale
Standard Deviation 19.55
|
-2.53 Unit on a scale
Standard Deviation 17.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C11D1
|
-3.29 Unit on a scale
Standard Deviation 21.48
|
-0.94 Unit on a scale
Standard Deviation 18.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C12D1
|
-1.33 Unit on a scale
Standard Deviation 17.71
|
-2.92 Unit on a scale
Standard Deviation 20.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C13D1
|
-3.89 Unit on a scale
Standard Deviation 16.34
|
-4.17 Unit on a scale
Standard Deviation 17.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C14D1
|
-3.03 Unit on a scale
Standard Deviation 17.30
|
-2.27 Unit on a scale
Standard Deviation 20.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C15D1
|
-1.31 Unit on a scale
Standard Deviation 19.96
|
-2.78 Unit on a scale
Standard Deviation 20.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C16D1
|
-1.39 Unit on a scale
Standard Deviation 16.78
|
-3.23 Unit on a scale
Standard Deviation 13.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C17D1
|
-0.78 Unit on a scale
Standard Deviation 19.91
|
-4.00 Unit on a scale
Standard Deviation 11.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C18D1
|
-1.63 Unit on a scale
Standard Deviation 16.59
|
-4.76 Unit on a scale
Standard Deviation 19.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C19D1
|
-2.50 Unit on a scale
Standard Deviation 15.81
|
-3.33 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C20D1
|
-1.71 Unit on a scale
Standard Deviation 17.01
|
-3.51 Unit on a scale
Standard Deviation 15.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C21D1
|
-0.93 Unit on a scale
Standard Deviation 18.66
|
-3.33 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C22D1
|
0.00 Unit on a scale
Standard Deviation 14.91
|
-5.88 Unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C23D1
|
1.08 Unit on a scale
Standard Deviation 16.06
|
-8.33 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C24D1
|
2.30 Unit on a scale
Standard Deviation 12.38
|
-2.78 Unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C25D1
|
0.00 Unit on a scale
Standard Deviation 15.71
|
-2.78 Unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C26D1
|
0.00 Unit on a scale
Standard Deviation 13.33
|
0.00 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C27D1
|
1.33 Unit on a scale
Standard Deviation 15.15
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C28D1
|
0.00 Unit on a scale
Standard Deviation 14.91
|
-6.06 Unit on a scale
Standard Deviation 20.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C29D1
|
3.03 Unit on a scale
Standard Deviation 17.55
|
-8.33 Unit on a scale
Standard Deviation 25.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C30D1
|
1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C31D1
|
-1.67 Unit on a scale
Standard Deviation 13.13
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C32D1
|
5.56 Unit on a scale
Standard Deviation 17.15
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C33D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C34D1
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C35D1
|
2.56 Unit on a scale
Standard Deviation 16.45
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C36D1
|
0.00 Unit on a scale
Standard Deviation 14.21
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C37D1
|
0.00 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C38D1
|
6.67 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C39D1
|
3.70 Unit on a scale
Standard Deviation 20.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea 30 day follow up
|
-0.58 Unit on a scale
Standard Deviation 18.36
|
1.71 Unit on a scale
Standard Deviation 19.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea 90 day follow up
|
2.73 Unit on a scale
Standard Deviation 20.45
|
-1.27 Unit on a scale
Standard Deviation 23.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties Baseline
|
20.71 Unit on a scale
Standard Deviation 25.99
|
19.42 Unit on a scale
Standard Deviation 25.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C2D1
|
-0.64 Unit on a scale
Standard Deviation 25.58
|
-0.92 Unit on a scale
Standard Deviation 18.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C3D1
|
-0.92 Unit on a scale
Standard Deviation 25.13
|
1.18 Unit on a scale
Standard Deviation 22.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C4D1
|
-2.17 Unit on a scale
Standard Deviation 23.33
|
-1.58 Unit on a scale
Standard Deviation 22.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C27D1
|
-4.00 Unit on a scale
Standard Deviation 17.53
|
6.67 Unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C28D1
|
-1.59 Unit on a scale
Standard Deviation 19.65
|
15.15 Unit on a scale
Standard Deviation 27.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C29D1
|
1.52 Unit on a scale
Standard Deviation 21.77
|
8.33 Unit on a scale
Standard Deviation 25.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C30D1
|
-1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C31D1
|
1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C32D1
|
0.00 Unit on a scale
Standard Deviation 22.87
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C33D1
|
-2.22 Unit on a scale
Standard Deviation 19.79
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C5D1
|
-0.63 Unit on a scale
Standard Deviation 28.92
|
0.81 Unit on a scale
Standard Deviation 19.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C6D1
|
-0.89 Unit on a scale
Standard Deviation 27.66
|
0.00 Unit on a scale
Standard Deviation 21.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C20D1
|
0.00 Unit on a scale
Standard Deviation 24.18
|
-1.75 Unit on a scale
Standard Deviation 20.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C21D1
|
1.85 Unit on a scale
Standard Deviation 25.13
|
3.33 Unit on a scale
Standard Deviation 21.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C22D1
|
-3.23 Unit on a scale
Standard Deviation 21.70
|
3.92 Unit on a scale
Standard Deviation 26.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C34D1
|
-2.78 Unit on a scale
Standard Deviation 22.29
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C24D1
|
1.15 Unit on a scale
Standard Deviation 22.68
|
2.78 Unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C25D1
|
0.00 Unit on a scale
Standard Deviation 22.22
|
8.33 Unit on a scale
Standard Deviation 20.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C26D1
|
-2.56 Unit on a scale
Standard Deviation 20.92
|
-7.41 Unit on a scale
Standard Deviation 14.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C27D1
|
1.33 Unit on a scale
Standard Deviation 17.95
|
-6.67 Unit on a scale
Standard Deviation 14.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C28D1
|
-4.76 Unit on a scale
Standard Deviation 21.82
|
-3.03 Unit on a scale
Standard Deviation 17.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C30D1
|
0.00 Unit on a scale
Standard Deviation 24.18
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C31D1
|
0.00 Unit on a scale
Standard Deviation 21.63
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C32D1
|
-5.56 Unit on a scale
Standard Deviation 17.15
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C33D1
|
-6.67 Unit on a scale
Standard Deviation 13.80
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C34D1
|
-5.56 Unit on a scale
Standard Deviation 12.97
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C35D1
|
-2.56 Unit on a scale
Standard Deviation 16.45
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C36D1
|
-2.78 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C37D1
|
-6.06 Unit on a scale
Standard Deviation 13.48
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C39D1
|
-3.70 Unit on a scale
Standard Deviation 20.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties 30 day follow up
|
4.09 Unit on a scale
Standard Deviation 26.03
|
9.40 Unit on a scale
Standard Deviation 24.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties 90 day follow up
|
3.28 Unit on a scale
Standard Deviation 24.87
|
3.80 Unit on a scale
Standard Deviation 20.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C7D1
|
0.56 Unit on a scale
Standard Deviation 24.05
|
0.26 Unit on a scale
Standard Deviation 24.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C8D1
|
-0.62 Unit on a scale
Standard Deviation 26.95
|
3.33 Unit on a scale
Standard Deviation 23.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C9D1
|
2.29 Unit on a scale
Standard Deviation 24.94
|
1.94 Unit on a scale
Standard Deviation 21.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C10D1
|
-2.75 Unit on a scale
Standard Deviation 27.80
|
1.27 Unit on a scale
Standard Deviation 24.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C11D1
|
0.00 Unit on a scale
Standard Deviation 27.39
|
4.69 Unit on a scale
Standard Deviation 22.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C12D1
|
-0.89 Unit on a scale
Standard Deviation 30.00
|
3.51 Unit on a scale
Standard Deviation 22.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C13D1
|
-3.33 Unit on a scale
Standard Deviation 27.92
|
4.17 Unit on a scale
Standard Deviation 25.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C14D1
|
-0.61 Unit on a scale
Standard Deviation 29.04
|
0.00 Unit on a scale
Standard Deviation 23.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C15D1
|
0.00 Unit on a scale
Standard Deviation 29.06
|
4.63 Unit on a scale
Standard Deviation 24.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C17D1
|
-2.33 Unit on a scale
Standard Deviation 23.45
|
1.33 Unit on a scale
Standard Deviation 20.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C18D1
|
3.25 Unit on a scale
Standard Deviation 22.12
|
4.76 Unit on a scale
Standard Deviation 24.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C19D1
|
-2.50 Unit on a scale
Standard Deviation 21.86
|
-3.33 Unit on a scale
Standard Deviation 18.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C11D1
|
-0.82 Unit on a scale
Standard Deviation 15.00
|
-0.09 Unit on a scale
Standard Deviation 17.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C12D1
|
-0.89 Unit on a scale
Standard Deviation 17.31
|
-0.70 Unit on a scale
Standard Deviation 19.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C13D1
|
-0.56 Unit on a scale
Standard Deviation 18.59
|
0.97 Unit on a scale
Standard Deviation 13.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C14D1
|
0.12 Unit on a scale
Standard Deviation 15.95
|
1.21 Unit on a scale
Standard Deviation 13.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C15D1
|
0.39 Unit on a scale
Standard Deviation 14.20
|
0.00 Unit on a scale
Standard Deviation 13.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C16D1
|
-0.42 Unit on a scale
Standard Deviation 14.77
|
0.86 Unit on a scale
Standard Deviation 12.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C17D1
|
2.33 Unit on a scale
Standard Deviation 14.61
|
2.13 Unit on a scale
Standard Deviation 16.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C18D1
|
-2.93 Unit on a scale
Standard Deviation 17.32
|
3.49 Unit on a scale
Standard Deviation 15.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C19D1
|
1.33 Unit on a scale
Standard Deviation 10.48
|
4.00 Unit on a scale
Standard Deviation 13.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C20D1
|
-0.85 Unit on a scale
Standard Deviation 11.96
|
2.81 Unit on a scale
Standard Deviation 16.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C21D1
|
-0.74 Unit on a scale
Standard Deviation 13.31
|
3.33 Unit on a scale
Standard Deviation 12.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C22D1
|
-0.22 Unit on a scale
Standard Deviation 12.11
|
5.49 Unit on a scale
Standard Deviation 17.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C23D1
|
-0.22 Unit on a scale
Standard Deviation 14.35
|
5.83 Unit on a scale
Standard Deviation 19.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C24D1
|
2.30 Unit on a scale
Standard Deviation 14.61
|
5.56 Unit on a scale
Standard Deviation 17.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C25D1
|
0.48 Unit on a scale
Standard Deviation 17.40
|
3.89 Unit on a scale
Standard Deviation 23.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C26D1
|
1.28 Unit on a scale
Standard Deviation 17.28
|
2.96 Unit on a scale
Standard Deviation 17.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C27D1
|
1.07 Unit on a scale
Standard Deviation 16.52
|
2.00 Unit on a scale
Standard Deviation 13.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C28D1
|
-1.27 Unit on a scale
Standard Deviation 16.55
|
-1.82 Unit on a scale
Standard Deviation 19.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C16D1
|
0.00 Unit on a scale
Standard Deviation 25.73
|
6.45 Unit on a scale
Standard Deviation 24.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C12D1
|
-0.89 Unit on a scale
Standard Deviation 27.39
|
-0.58 Unit on a scale
Standard Deviation 29.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C13D1
|
-3.33 Unit on a scale
Standard Deviation 24.32
|
1.39 Unit on a scale
Standard Deviation 33.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C14D1
|
0.61 Unit on a scale
Standard Deviation 27.59
|
-0.76 Unit on a scale
Standard Deviation 33.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C23D1
|
-3.23 Unit on a scale
Standard Deviation 15.76
|
4.17 Unit on a scale
Standard Deviation 34.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C24D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
0.00 Unit on a scale
Standard Deviation 24.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C25D1
|
-2.38 Unit on a scale
Standard Deviation 20.14
|
2.78 Unit on a scale
Standard Deviation 22.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C26D1
|
-2.56 Unit on a scale
Standard Deviation 18.67
|
3.70 Unit on a scale
Standard Deviation 20.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C35D1
|
0.00 Unit on a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C37D1
|
3.03 Unit on a scale
Standard Deviation 23.35
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C38D1
|
6.67 Unit on a scale
Standard Deviation 34.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C39D1
|
7.41 Unit on a scale
Standard Deviation 22.22
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia 30 day follow up
|
6.43 Unit on a scale
Standard Deviation 30.50
|
8.55 Unit on a scale
Standard Deviation 36.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia 90 day follow up
|
6.56 Unit on a scale
Standard Deviation 22.62
|
0.42 Unit on a scale
Standard Deviation 28.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss Baseline
|
26.20 Unit on a scale
Standard Deviation 29.91
|
24.66 Unit on a scale
Standard Deviation 29.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C2D1
|
3.69 Unit on a scale
Standard Deviation 31.97
|
-2.61 Unit on a scale
Standard Deviation 27.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C3D1
|
0.73 Unit on a scale
Standard Deviation 34.86
|
-2.71 Unit on a scale
Standard Deviation 27.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C4D1
|
-3.55 Unit on a scale
Standard Deviation 34.32
|
-5.13 Unit on a scale
Standard Deviation 33.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C5D1
|
-2.94 Unit on a scale
Standard Deviation 36.24
|
-4.44 Unit on a scale
Standard Deviation 33.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C6D1
|
-0.22 Unit on a scale
Standard Deviation 34.55
|
-2.51 Unit on a scale
Standard Deviation 33.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C7D1
|
-4.44 Unit on a scale
Standard Deviation 37.41
|
-6.88 Unit on a scale
Standard Deviation 31.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C8D1
|
-1.23 Unit on a scale
Standard Deviation 31.55
|
-6.36 Unit on a scale
Standard Deviation 32.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C9D1
|
-3.92 Unit on a scale
Standard Deviation 36.72
|
-7.12 Unit on a scale
Standard Deviation 34.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C10D1
|
-3.92 Unit on a scale
Standard Deviation 31.04
|
-10.13 Unit on a scale
Standard Deviation 32.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C11D1
|
-7.82 Unit on a scale
Standard Deviation 31.30
|
-12.21 Unit on a scale
Standard Deviation 33.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C12D1
|
-8.00 Unit on a scale
Standard Deviation 31.40
|
-11.11 Unit on a scale
Standard Deviation 30.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C13D1
|
-9.44 Unit on a scale
Standard Deviation 36.36
|
-12.50 Unit on a scale
Standard Deviation 31.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C15D1
|
-9.80 Unit on a scale
Standard Deviation 30.03
|
-11.11 Unit on a scale
Standard Deviation 29.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C16D1
|
-9.72 Unit on a scale
Standard Deviation 32.22
|
-8.60 Unit on a scale
Standard Deviation 32.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C17D1
|
-8.53 Unit on a scale
Standard Deviation 32.61
|
-6.67 Unit on a scale
Standard Deviation 36.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C18D1
|
-12.20 Unit on a scale
Standard Deviation 32.28
|
-9.52 Unit on a scale
Standard Deviation 35.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C19D1
|
-14.17 Unit on a scale
Standard Deviation 30.09
|
-15.00 Unit on a scale
Standard Deviation 20.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C20D1
|
-7.69 Unit on a scale
Standard Deviation 33.74
|
-15.79 Unit on a scale
Standard Deviation 30.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C21D1
|
-4.63 Unit on a scale
Standard Deviation 33.00
|
-10.00 Unit on a scale
Standard Deviation 34.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C22D1
|
-10.75 Unit on a scale
Standard Deviation 32.65
|
-17.65 Unit on a scale
Standard Deviation 31.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C23D1
|
-10.75 Unit on a scale
Standard Deviation 30.29
|
-14.58 Unit on a scale
Standard Deviation 40.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C24D1
|
-13.79 Unit on a scale
Standard Deviation 28.89
|
-16.67 Unit on a scale
Standard Deviation 33.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C25D1
|
-10.71 Unit on a scale
Standard Deviation 30.16
|
-16.67 Unit on a scale
Standard Deviation 33.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C26D1
|
-12.82 Unit on a scale
Standard Deviation 35.37
|
-14.81 Unit on a scale
Standard Deviation 17.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C27D1
|
-8.00 Unit on a scale
Standard Deviation 30.85
|
-10.00 Unit on a scale
Standard Deviation 31.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C28D1
|
-14.29 Unit on a scale
Standard Deviation 32.61
|
0.00 Unit on a scale
Standard Deviation 29.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C29D1
|
-16.67 Unit on a scale
Standard Deviation 28.64
|
-11.11 Unit on a scale
Standard Deviation 29.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C30D1
|
-10.00 Unit on a scale
Standard Deviation 32.62
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C31D1
|
-16.67 Unit on a scale
Standard Deviation 31.53
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C32D1
|
-14.81 Unit on a scale
Standard Deviation 36.55
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C33D1
|
-17.78 Unit on a scale
Standard Deviation 37.52
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C34D1
|
-27.78 Unit on a scale
Standard Deviation 34.33
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C35D1
|
-17.95 Unit on a scale
Standard Deviation 35.00
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C36D1
|
-19.44 Unit on a scale
Standard Deviation 36.12
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C37D1
|
-18.18 Unit on a scale
Standard Deviation 37.61
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C38D1
|
-23.33 Unit on a scale
Standard Deviation 41.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C39D1
|
-18.52 Unit on a scale
Standard Deviation 37.68
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss 30 day follow up
|
4.68 Unit on a scale
Standard Deviation 38.03
|
6.41 Unit on a scale
Standard Deviation 29.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss 90 day follow up
|
3.28 Unit on a scale
Standard Deviation 38.83
|
0.84 Unit on a scale
Standard Deviation 32.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation Baseline
|
18.11 Unit on a scale
Standard Deviation 26.09
|
17.63 Unit on a scale
Standard Deviation 27.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C2D1
|
-0.64 Unit on a scale
Standard Deviation 24.94
|
-2.76 Unit on a scale
Standard Deviation 25.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C3D1
|
-2.38 Unit on a scale
Standard Deviation 26.23
|
-5.25 Unit on a scale
Standard Deviation 23.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C4D1
|
-4.73 Unit on a scale
Standard Deviation 26.30
|
-6.90 Unit on a scale
Standard Deviation 29.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C5D1
|
-2.73 Unit on a scale
Standard Deviation 25.97
|
-4.65 Unit on a scale
Standard Deviation 26.77
|
SECONDARY outcome
Timeframe: Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow upPopulation: FAS with available data was analyzed.
OG25 evaluated gastric \& gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain \& discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100;higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=243 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=242 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C8D1
|
-2.88 Unit on a scale
Standard Deviation 18.81
|
-4.28 Unit on a scale
Standard Deviation 17.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C10D1
|
-3.27 Unit on a scale
Standard Deviation 16.61
|
-6.75 Unit on a scale
Standard Deviation 18.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C16D1
|
-2.31 Unit on a scale
Standard Deviation 14.85
|
0.00 Unit on a scale
Standard Deviation 12.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C19D1
|
-4.17 Unit on a scale
Standard Deviation 13.48
|
-2.78 Unit on a scale
Standard Deviation 7.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C25D1
|
-5.95 Unit on a scale
Standard Deviation 23.34
|
-8.33 Unit on a scale
Standard Deviation 18.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C28D1
|
-6.35 Unit on a scale
Standard Deviation 24.71
|
2.27 Unit on a scale
Standard Deviation 7.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions 90 day follow up
|
-2.19 Unit on a scale
Standard Deviation 22.77
|
-0.42 Unit on a scale
Standard Deviation 23.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux Baseline
|
13.17 Unit on a scale
Standard Deviation 20.28
|
16.11 Unit on a scale
Standard Deviation 22.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C12D1
|
-4.44 Unit on a scale
Standard Deviation 22.48
|
-8.48 Unit on a scale
Standard Deviation 23.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C15D1
|
-3.92 Unit on a scale
Standard Deviation 18.13
|
-7.41 Unit on a scale
Standard Deviation 24.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C16D1
|
-3.13 Unit on a scale
Standard Deviation 23.23
|
-4.84 Unit on a scale
Standard Deviation 20.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C22D1
|
-5.38 Unit on a scale
Standard Deviation 17.94
|
-1.96 Unit on a scale
Standard Deviation 26.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C25D1
|
-1.19 Unit on a scale
Standard Deviation 19.74
|
-4.17 Unit on a scale
Standard Deviation 25.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C29D1
|
-3.03 Unit on a scale
Standard Deviation 14.21
|
-1.39 Unit on a scale
Standard Deviation 8.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C3D1
|
-3.94 Unit on a scale
Standard Deviation 19.38
|
-6.04 Unit on a scale
Standard Deviation 20.37
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C31D1
|
-7.50 Unit on a scale
Standard Deviation 28.34
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C2D1
|
-3.21 Unit on a scale
Standard Deviation 18.25
|
-3.09 Unit on a scale
Standard Deviation 19.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C7D1
|
-0.84 Unit on a scale
Standard Deviation 18.13
|
-4.53 Unit on a scale
Standard Deviation 20.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C27D1
|
-2.67 Unit on a scale
Standard Deviation 19.05
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C38D1
|
-16.67 Unit on a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C39D1
|
-7.41 Unit on a scale
Standard Deviation 14.70
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others 90 day follow up
|
3.28 Unit on a scale
Standard Deviation 18.96
|
2.53 Unit on a scale
Standard Deviation 16.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth Baseline
|
19.20 Unit on a scale
Standard Deviation 24.74
|
16.87 Unit on a scale
Standard Deviation 23.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C2D1
|
-0.32 Unit on a scale
Standard Deviation 23.40
|
2.16 Unit on a scale
Standard Deviation 23.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C4D1
|
-2.01 Unit on a scale
Standard Deviation 25.08
|
4.34 Unit on a scale
Standard Deviation 28.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C5D1
|
-1.05 Unit on a scale
Standard Deviation 26.89
|
1.41 Unit on a scale
Standard Deviation 27.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C6D1
|
0.89 Unit on a scale
Standard Deviation 27.93
|
3.91 Unit on a scale
Standard Deviation 27.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C7D1
|
-0.28 Unit on a scale
Standard Deviation 27.62
|
0.53 Unit on a scale
Standard Deviation 28.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C11D1
|
-4.58 Unit on a scale
Standard Deviation 26.38
|
-2.35 Unit on a scale
Standard Deviation 26.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C2D1
|
3.85 Unit on a scale
Standard Deviation 22.85
|
2.47 Unit on a scale
Standard Deviation 20.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C6D1
|
3.58 Unit on a scale
Standard Deviation 24.55
|
-1.38 Unit on a scale
Standard Deviation 26.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C8D1
|
2.78 Unit on a scale
Standard Deviation 26.62
|
0.00 Unit on a scale
Standard Deviation 24.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C10D1
|
-1.57 Unit on a scale
Standard Deviation 29.95
|
-0.42 Unit on a scale
Standard Deviation 26.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C13D1
|
-7.22 Unit on a scale
Standard Deviation 30.12
|
0.00 Unit on a scale
Standard Deviation 26.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C20D1
|
-3.42 Unit on a scale
Standard Deviation 23.93
|
-3.51 Unit on a scale
Standard Deviation 29.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C22D1
|
-5.38 Unit on a scale
Standard Deviation 24.49
|
-3.92 Unit on a scale
Standard Deviation 30.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C38D1
|
-16.67 Unit on a scale
Standard Deviation 17.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C39D1
|
-11.11 Unit on a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image 90 day follow up
|
7.10 Unit on a scale
Standard Deviation 20.29
|
6.75 Unit on a scale
Standard Deviation 29.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C29D1
|
1.52 Unit on a scale
Standard Deviation 12.50
|
-8.33 Unit on a scale
Standard Deviation 20.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C15D1
|
-3.92 Unit on a scale
Standard Deviation 12.73
|
0.93 Unit on a scale
Standard Deviation 24.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C36D1
|
2.78 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C38D1
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing 90 day follow up
|
0.00 Unit on a scale
Standard Deviation 14.91
|
-1.69 Unit on a scale
Standard Deviation 21.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C12D1
|
-2.67 Unit on a scale
Standard Deviation 23.09
|
-8.19 Unit on a scale
Standard Deviation 22.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C20D1
|
-3.42 Unit on a scale
Standard Deviation 19.93
|
-5.26 Unit on a scale
Standard Deviation 22.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C35D1
|
-2.56 Unit on a scale
Standard Deviation 16.45
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing 30 day follow up
|
1.17 Unit on a scale
Standard Deviation 21.79
|
1.32 Unit on a scale
Standard Deviation 28.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C20D1
|
-2.56 Unit on a scale
Standard Deviation 14.07
|
1.75 Unit on a scale
Standard Deviation 13.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C21D1
|
-0.93 Unit on a scale
Standard Deviation 18.66
|
3.33 Unit on a scale
Standard Deviation 18.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C11D1
|
-9.58 Unit on a scale
Standard Deviation 30.56
|
-8.45 Unit on a scale
Standard Deviation 25.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C29D1
|
-13.64 Unit on a scale
Standard Deviation 19.68
|
-8.33 Unit on a scale
Standard Deviation 15.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C4D1
|
-0.63 Unit on a scale
Standard Deviation 24.01
|
0.00 Unit on a scale
Standard Deviation 15.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C5D1
|
-3.03 Unit on a scale
Standard Deviation 20.10
|
-0.81 Unit on a scale
Standard Deviation 18.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C7D1
|
-3.33 Unit on a scale
Standard Deviation 22.06
|
-4.60 Unit on a scale
Standard Deviation 17.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C8D1
|
-5.71 Unit on a scale
Standard Deviation 27.40
|
-8.97 Unit on a scale
Standard Deviation 20.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C9D1
|
-2.22 Unit on a scale
Standard Deviation 26.16
|
-9.52 Unit on a scale
Standard Deviation 26.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C15D1
|
6.06 Unit on a scale
Standard Deviation 25.03
|
-4.76 Unit on a scale
Standard Deviation 12.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss 90 day follow up
|
23.53 Unit on a scale
Standard Deviation 40.42
|
15.15 Unit on a scale
Standard Deviation 26.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C3D1
|
0.92 Unit on a scale
Standard Deviation 17.84
|
-1.87 Unit on a scale
Standard Deviation 16.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C6D1
|
0.00 Unit on a scale
Standard Deviation 16.67
|
-4.02 Unit on a scale
Standard Deviation 20.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C8D1
|
1.54 Unit on a scale
Standard Deviation 20.95
|
-5.05 Unit on a scale
Standard Deviation 21.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C10D1
|
0.39 Unit on a scale
Standard Deviation 18.54
|
-7.38 Unit on a scale
Standard Deviation 19.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C11D1
|
-2.08 Unit on a scale
Standard Deviation 17.26
|
-9.62 Unit on a scale
Standard Deviation 21.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C12D1
|
-1.78 Unit on a scale
Standard Deviation 16.11
|
-7.60 Unit on a scale
Standard Deviation 18.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C17D1
|
-2.71 Unit on a scale
Standard Deviation 18.87
|
-5.33 Unit on a scale
Standard Deviation 22.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C18D1
|
-2.03 Unit on a scale
Standard Deviation 17.16
|
-3.17 Unit on a scale
Standard Deviation 27.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C20D1
|
1.28 Unit on a scale
Standard Deviation 18.09
|
-7.02 Unit on a scale
Standard Deviation 21.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C21D1
|
-0.93 Unit on a scale
Standard Deviation 14.33
|
-5.00 Unit on a scale
Standard Deviation 23.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C24D1
|
0.00 Unit on a scale
Standard Deviation 16.67
|
-5.56 Unit on a scale
Standard Deviation 32.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C27D1
|
0.00 Unit on a scale
Standard Deviation 15.21
|
0.00 Unit on a scale
Standard Deviation 13.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C7D1
|
-3.64 Unit on a scale
Standard Deviation 23.28
|
-8.80 Unit on a scale
Standard Deviation 26.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C8D1
|
-4.32 Unit on a scale
Standard Deviation 25.21
|
-8.87 Unit on a scale
Standard Deviation 29.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C9D1
|
-5.23 Unit on a scale
Standard Deviation 25.80
|
-6.96 Unit on a scale
Standard Deviation 26.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C10D1
|
-7.45 Unit on a scale
Standard Deviation 28.11
|
-11.60 Unit on a scale
Standard Deviation 32.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C11D1
|
-7.29 Unit on a scale
Standard Deviation 28.54
|
-8.69 Unit on a scale
Standard Deviation 31.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C12D1
|
-10.00 Unit on a scale
Standard Deviation 29.38
|
-8.19 Unit on a scale
Standard Deviation 31.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C13D1
|
-7.78 Unit on a scale
Standard Deviation 30.76
|
-6.60 Unit on a scale
Standard Deviation 31.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C14D1
|
-7.88 Unit on a scale
Standard Deviation 28.30
|
-5.68 Unit on a scale
Standard Deviation 31.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C15D1
|
-8.50 Unit on a scale
Standard Deviation 28.55
|
-6.02 Unit on a scale
Standard Deviation 33.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C16D1
|
-15.62 Unit on a scale
Standard Deviation 27.38
|
-3.76 Unit on a scale
Standard Deviation 37.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C17D1
|
-6.98 Unit on a scale
Standard Deviation 24.19
|
-6.67 Unit on a scale
Standard Deviation 34.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia Baseline
|
12.12 Unit on a scale
Standard Deviation 18.27
|
12.59 Unit on a scale
Standard Deviation 19.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C2D1
|
-0.37 Unit on a scale
Standard Deviation 17.07
|
-3.86 Unit on a scale
Standard Deviation 15.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C3D1
|
-0.92 Unit on a scale
Standard Deviation 15.22
|
-4.59 Unit on a scale
Standard Deviation 16.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C4D1
|
-2.68 Unit on a scale
Standard Deviation 17.13
|
-5.00 Unit on a scale
Standard Deviation 17.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C5D1
|
-1.05 Unit on a scale
Standard Deviation 20.30
|
-5.66 Unit on a scale
Standard Deviation 17.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C18D1
|
-7.32 Unit on a scale
Standard Deviation 28.64
|
-10.32 Unit on a scale
Standard Deviation 37.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C19D1
|
-8.33 Unit on a scale
Standard Deviation 25.88
|
-2.50 Unit on a scale
Standard Deviation 27.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C20D1
|
-9.83 Unit on a scale
Standard Deviation 24.99
|
-8.77 Unit on a scale
Standard Deviation 35.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C6D1
|
-1.42 Unit on a scale
Standard Deviation 16.81
|
-3.45 Unit on a scale
Standard Deviation 19.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C7D1
|
-2.61 Unit on a scale
Standard Deviation 16.28
|
-5.16 Unit on a scale
Standard Deviation 17.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C9D1
|
-2.83 Unit on a scale
Standard Deviation 17.67
|
-5.93 Unit on a scale
Standard Deviation 17.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C11D1
|
-3.33 Unit on a scale
Standard Deviation 16.90
|
-5.95 Unit on a scale
Standard Deviation 19.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C12D1
|
-3.70 Unit on a scale
Standard Deviation 17.07
|
-5.65 Unit on a scale
Standard Deviation 16.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C13D1
|
-6.30 Unit on a scale
Standard Deviation 17.64
|
-4.40 Unit on a scale
Standard Deviation 14.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C14D1
|
-4.24 Unit on a scale
Standard Deviation 15.49
|
-3.03 Unit on a scale
Standard Deviation 14.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C15D1
|
-3.49 Unit on a scale
Standard Deviation 14.82
|
-1.54 Unit on a scale
Standard Deviation 17.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C17D1
|
-3.10 Unit on a scale
Standard Deviation 13.13
|
-1.78 Unit on a scale
Standard Deviation 11.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C18D1
|
-3.25 Unit on a scale
Standard Deviation 14.96
|
-4.23 Unit on a scale
Standard Deviation 10.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C21D1
|
-9.26 Unit on a scale
Standard Deviation 29.93
|
-11.67 Unit on a scale
Standard Deviation 35.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C22D1
|
-4.84 Unit on a scale
Standard Deviation 27.28
|
-7.84 Unit on a scale
Standard Deviation 40.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C20D1
|
-4.56 Unit on a scale
Standard Deviation 11.60
|
-2.92 Unit on a scale
Standard Deviation 11.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C21D1
|
-3.40 Unit on a scale
Standard Deviation 15.22
|
-3.33 Unit on a scale
Standard Deviation 13.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C22D1
|
-5.38 Unit on a scale
Standard Deviation 15.94
|
-5.23 Unit on a scale
Standard Deviation 9.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C23D1
|
-4.30 Unit on a scale
Standard Deviation 14.54
|
-5.56 Unit on a scale
Standard Deviation 10.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C24D1
|
-4.98 Unit on a scale
Standard Deviation 13.80
|
-2.78 Unit on a scale
Standard Deviation 11.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C25D1
|
-4.37 Unit on a scale
Standard Deviation 12.95
|
-3.70 Unit on a scale
Standard Deviation 10.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C26D1
|
-2.99 Unit on a scale
Standard Deviation 18.21
|
2.47 Unit on a scale
Standard Deviation 9.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C27D1
|
-5.33 Unit on a scale
Standard Deviation 12.88
|
0.00 Unit on a scale
Standard Deviation 5.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C28D1
|
-4.76 Unit on a scale
Standard Deviation 14.30
|
1.01 Unit on a scale
Standard Deviation 5.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C29D1
|
-7.07 Unit on a scale
Standard Deviation 13.95
|
1.85 Unit on a scale
Standard Deviation 13.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C30D1
|
-5.00 Unit on a scale
Standard Deviation 15.07
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C31D1
|
-6.11 Unit on a scale
Standard Deviation 13.72
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C32D1
|
-7.41 Unit on a scale
Standard Deviation 14.76
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C33D1
|
-3.70 Unit on a scale
Standard Deviation 16.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C34D1
|
-8.33 Unit on a scale
Standard Deviation 19.03
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C35D1
|
-6.84 Unit on a scale
Standard Deviation 19.53
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C36D1
|
-9.26 Unit on a scale
Standard Deviation 19.44
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C37D1
|
-8.08 Unit on a scale
Standard Deviation 14.13
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C38D1
|
-6.67 Unit on a scale
Standard Deviation 16.73
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia C39D1
|
-4.94 Unit on a scale
Standard Deviation 12.56
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia 30 day follow up
|
4.48 Unit on a scale
Standard Deviation 22.60
|
0.73 Unit on a scale
Standard Deviation 24.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dysphagia 90 day follow up
|
0.36 Unit on a scale
Standard Deviation 12.33
|
-1.83 Unit on a scale
Standard Deviation 19.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions Baseline
|
22.67 Unit on a scale
Standard Deviation 25.20
|
22.51 Unit on a scale
Standard Deviation 24.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C2D1
|
-1.24 Unit on a scale
Standard Deviation 21.39
|
-4.55 Unit on a scale
Standard Deviation 20.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C3D1
|
-4.12 Unit on a scale
Standard Deviation 20.26
|
-6.08 Unit on a scale
Standard Deviation 20.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C4D1
|
-5.52 Unit on a scale
Standard Deviation 21.76
|
-8.19 Unit on a scale
Standard Deviation 21.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C5D1
|
-5.14 Unit on a scale
Standard Deviation 23.77
|
-7.22 Unit on a scale
Standard Deviation 22.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C6D1
|
-3.97 Unit on a scale
Standard Deviation 21.24
|
-6.03 Unit on a scale
Standard Deviation 23.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C7D1
|
-4.69 Unit on a scale
Standard Deviation 21.03
|
-5.07 Unit on a scale
Standard Deviation 22.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C8D1
|
-3.70 Unit on a scale
Standard Deviation 21.87
|
-6.27 Unit on a scale
Standard Deviation 24.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C9D1
|
-3.59 Unit on a scale
Standard Deviation 22.75
|
-7.52 Unit on a scale
Standard Deviation 22.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C10D1
|
-4.80 Unit on a scale
Standard Deviation 24.03
|
-8.54 Unit on a scale
Standard Deviation 26.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C11D1
|
-5.83 Unit on a scale
Standard Deviation 25.96
|
-9.39 Unit on a scale
Standard Deviation 27.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C12D1
|
-6.22 Unit on a scale
Standard Deviation 27.47
|
-9.36 Unit on a scale
Standard Deviation 22.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C13D1
|
-9.31 Unit on a scale
Standard Deviation 28.04
|
-10.59 Unit on a scale
Standard Deviation 21.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C14D1
|
-6.97 Unit on a scale
Standard Deviation 25.45
|
-7.39 Unit on a scale
Standard Deviation 22.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C15D1
|
-7.03 Unit on a scale
Standard Deviation 24.46
|
-6.25 Unit on a scale
Standard Deviation 21.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C16D1
|
-8.68 Unit on a scale
Standard Deviation 22.41
|
-6.72 Unit on a scale
Standard Deviation 20.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C23D1
|
-10.22 Unit on a scale
Standard Deviation 26.76
|
-10.42 Unit on a scale
Standard Deviation 35.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C17D1
|
-7.75 Unit on a scale
Standard Deviation 22.67
|
-3.33 Unit on a scale
Standard Deviation 21.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C18D1
|
-7.11 Unit on a scale
Standard Deviation 23.68
|
-10.32 Unit on a scale
Standard Deviation 21.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C19D1
|
-7.92 Unit on a scale
Standard Deviation 20.06
|
-9.17 Unit on a scale
Standard Deviation 14.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C20D1
|
-6.41 Unit on a scale
Standard Deviation 22.98
|
-9.21 Unit on a scale
Standard Deviation 20.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C21D1
|
-5.32 Unit on a scale
Standard Deviation 20.52
|
-10.00 Unit on a scale
Standard Deviation 19.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C22D1
|
-7.26 Unit on a scale
Standard Deviation 23.93
|
-12.25 Unit on a scale
Standard Deviation 22.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C23D1
|
-6.18 Unit on a scale
Standard Deviation 20.07
|
-12.50 Unit on a scale
Standard Deviation 19.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C24D1
|
-6.03 Unit on a scale
Standard Deviation 21.12
|
-6.25 Unit on a scale
Standard Deviation 20.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C26D1
|
-7.37 Unit on a scale
Standard Deviation 25.31
|
-2.78 Unit on a scale
Standard Deviation 17.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C27D1
|
-7.67 Unit on a scale
Standard Deviation 22.30
|
-3.33 Unit on a scale
Standard Deviation 13.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C29D1
|
-10.23 Unit on a scale
Standard Deviation 19.57
|
-3.47 Unit on a scale
Standard Deviation 19.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C30D1
|
-5.42 Unit on a scale
Standard Deviation 22.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C31D1
|
-10.42 Unit on a scale
Standard Deviation 20.75
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C32D1
|
-9.26 Unit on a scale
Standard Deviation 23.90
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C33D1
|
-7.78 Unit on a scale
Standard Deviation 13.90
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C34D1
|
-17.36 Unit on a scale
Standard Deviation 25.74
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C35D1
|
-11.54 Unit on a scale
Standard Deviation 26.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C36D1
|
-15.97 Unit on a scale
Standard Deviation 25.24
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C37D1
|
-12.12 Unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C38D1
|
-17.50 Unit on a scale
Standard Deviation 21.68
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions C39D1
|
-7.41 Unit on a scale
Standard Deviation 13.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating Restrictions 30 day follow up
|
0.15 Unit on a scale
Standard Deviation 27.57
|
0.88 Unit on a scale
Standard Deviation 23.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C2D1
|
-1.04 Unit on a scale
Standard Deviation 20.79
|
-4.01 Unit on a scale
Standard Deviation 18.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C3D1
|
-0.09 Unit on a scale
Standard Deviation 21.71
|
-4.17 Unit on a scale
Standard Deviation 18.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C4D1
|
-0.70 Unit on a scale
Standard Deviation 22.80
|
-5.82 Unit on a scale
Standard Deviation 21.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C5D1
|
-0.84 Unit on a scale
Standard Deviation 22.17
|
-7.88 Unit on a scale
Standard Deviation 19.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C6D1
|
-0.11 Unit on a scale
Standard Deviation 22.39
|
-7.01 Unit on a scale
Standard Deviation 20.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C7D1
|
-1.68 Unit on a scale
Standard Deviation 20.40
|
-6.67 Unit on a scale
Standard Deviation 21.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C8D1
|
-1.08 Unit on a scale
Standard Deviation 23.04
|
-9.17 Unit on a scale
Standard Deviation 21.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C9D1
|
-0.82 Unit on a scale
Standard Deviation 27.49
|
-11.00 Unit on a scale
Standard Deviation 20.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C10D1
|
-1.57 Unit on a scale
Standard Deviation 23.80
|
-10.34 Unit on a scale
Standard Deviation 22.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C11D1
|
-3.13 Unit on a scale
Standard Deviation 21.23
|
-11.03 Unit on a scale
Standard Deviation 24.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C13D1
|
-3.33 Unit on a scale
Standard Deviation 28.26
|
-9.03 Unit on a scale
Standard Deviation 24.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C14D1
|
-1.82 Unit on a scale
Standard Deviation 22.38
|
-8.71 Unit on a scale
Standard Deviation 20.80
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C17D1
|
-5.81 Unit on a scale
Standard Deviation 22.09
|
-2.67 Unit on a scale
Standard Deviation 21.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C18D1
|
-3.25 Unit on a scale
Standard Deviation 23.04
|
-3.17 Unit on a scale
Standard Deviation 23.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C19D1
|
-2.92 Unit on a scale
Standard Deviation 22.61
|
-1.67 Unit on a scale
Standard Deviation 13.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C20D1
|
0.00 Unit on a scale
Standard Deviation 20.94
|
-4.39 Unit on a scale
Standard Deviation 24.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C21D1
|
0.46 Unit on a scale
Standard Deviation 24.07
|
-2.50 Unit on a scale
Standard Deviation 27.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C24D1
|
-9.77 Unit on a scale
Standard Deviation 28.00
|
-9.72 Unit on a scale
Standard Deviation 41.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C23D1
|
-4.30 Unit on a scale
Standard Deviation 18.74
|
-4.17 Unit on a scale
Standard Deviation 24.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C24D1
|
-2.30 Unit on a scale
Standard Deviation 19.78
|
-6.94 Unit on a scale
Standard Deviation 26.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C26D1
|
-1.28 Unit on a scale
Standard Deviation 16.95
|
3.70 Unit on a scale
Standard Deviation 18.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C27D1
|
-1.33 Unit on a scale
Standard Deviation 17.29
|
1.67 Unit on a scale
Standard Deviation 12.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C28D1
|
0.00 Unit on a scale
Standard Deviation 17.48
|
3.03 Unit on a scale
Standard Deviation 16.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C11D1
|
-2.92 Unit on a scale
Standard Deviation 19.98
|
-4.69 Unit on a scale
Standard Deviation 19.76
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C30D1
|
-0.83 Unit on a scale
Standard Deviation 13.76
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C31D1
|
-1.67 Unit on a scale
Standard Deviation 16.13
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C32D1
|
0.00 Unit on a scale
Standard Deviation 18.96
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C33D1
|
-3.33 Unit on a scale
Standard Deviation 14.36
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C34D1
|
-4.17 Unit on a scale
Standard Deviation 18.97
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C35D1
|
1.28 Unit on a scale
Standard Deviation 19.79
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C36D1
|
-4.17 Unit on a scale
Standard Deviation 21.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C37D1
|
-4.55 Unit on a scale
Standard Deviation 18.40
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C38D1
|
0.00 Unit on a scale
Standard Deviation 20.79
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux C39D1
|
7.41 Unit on a scale
Standard Deviation 12.11
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux 30 day follow up
|
1.46 Unit on a scale
Standard Deviation 26.03
|
0.44 Unit on a scale
Standard Deviation 26.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Reflux 90 day follow up
|
2.19 Unit on a scale
Standard Deviation 19.83
|
-1.69 Unit on a scale
Standard Deviation 21.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia Baseline
|
15.64 Unit on a scale
Standard Deviation 22.78
|
17.29 Unit on a scale
Standard Deviation 24.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C2D1
|
-2.80 Unit on a scale
Standard Deviation 21.46
|
-4.63 Unit on a scale
Standard Deviation 22.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C4D1
|
-5.22 Unit on a scale
Standard Deviation 21.93
|
-8.19 Unit on a scale
Standard Deviation 21.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C5D1
|
-4.19 Unit on a scale
Standard Deviation 22.58
|
-7.58 Unit on a scale
Standard Deviation 23.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C6D1
|
-2.80 Unit on a scale
Standard Deviation 20.54
|
-5.98 Unit on a scale
Standard Deviation 22.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C7D1
|
-3.92 Unit on a scale
Standard Deviation 19.73
|
-5.33 Unit on a scale
Standard Deviation 24.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C8D1
|
-4.32 Unit on a scale
Standard Deviation 21.54
|
-7.19 Unit on a scale
Standard Deviation 23.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C9D1
|
-2.94 Unit on a scale
Standard Deviation 22.30
|
-7.93 Unit on a scale
Standard Deviation 24.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C10D1
|
-5.10 Unit on a scale
Standard Deviation 24.26
|
-8.02 Unit on a scale
Standard Deviation 28.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C11D1
|
-4.17 Unit on a scale
Standard Deviation 25.78
|
-9.62 Unit on a scale
Standard Deviation 27.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C12D1
|
-6.67 Unit on a scale
Standard Deviation 25.70
|
-7.60 Unit on a scale
Standard Deviation 22.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C13D1
|
-8.06 Unit on a scale
Standard Deviation 26.66
|
-7.99 Unit on a scale
Standard Deviation 25.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C14D1
|
-7.58 Unit on a scale
Standard Deviation 24.18
|
-5.68 Unit on a scale
Standard Deviation 24.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C15D1
|
-7.84 Unit on a scale
Standard Deviation 23.18
|
-3.24 Unit on a scale
Standard Deviation 27.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C12D1
|
-3.11 Unit on a scale
Standard Deviation 20.63
|
-4.09 Unit on a scale
Standard Deviation 14.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C13D1
|
-5.56 Unit on a scale
Standard Deviation 21.41
|
0.00 Unit on a scale
Standard Deviation 16.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C14D1
|
-4.85 Unit on a scale
Standard Deviation 20.71
|
-4.55 Unit on a scale
Standard Deviation 13.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C16D1
|
-9.37 Unit on a scale
Standard Deviation 21.99
|
0.00 Unit on a scale
Standard Deviation 23.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C17D1
|
-11.63 Unit on a scale
Standard Deviation 21.37
|
-2.67 Unit on a scale
Standard Deviation 24.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C18D1
|
-9.76 Unit on a scale
Standard Deviation 22.66
|
-5.56 Unit on a scale
Standard Deviation 23.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C19D1
|
-9.58 Unit on a scale
Standard Deviation 18.45
|
-2.50 Unit on a scale
Standard Deviation 13.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C20D1
|
-7.26 Unit on a scale
Standard Deviation 21.56
|
-7.02 Unit on a scale
Standard Deviation 25.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C25D1
|
-10.71 Unit on a scale
Standard Deviation 24.52
|
-11.11 Unit on a scale
Standard Deviation 40.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C26D1
|
-7.69 Unit on a scale
Standard Deviation 25.49
|
3.70 Unit on a scale
Standard Deviation 34.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C27D1
|
-9.33 Unit on a scale
Standard Deviation 30.08
|
6.67 Unit on a scale
Standard Deviation 29.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C28D1
|
-10.32 Unit on a scale
Standard Deviation 31.83
|
1.52 Unit on a scale
Standard Deviation 29.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C29D1
|
-6.82 Unit on a scale
Standard Deviation 33.20
|
1.39 Unit on a scale
Standard Deviation 37.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C30D1
|
-5.00 Unit on a scale
Standard Deviation 26.55
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C21D1
|
-5.09 Unit on a scale
Standard Deviation 18.61
|
-7.50 Unit on a scale
Standard Deviation 22.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C22D1
|
-5.91 Unit on a scale
Standard Deviation 19.51
|
-5.88 Unit on a scale
Standard Deviation 27.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C23D1
|
-7.53 Unit on a scale
Standard Deviation 21.01
|
-7.29 Unit on a scale
Standard Deviation 29.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C24D1
|
-6.90 Unit on a scale
Standard Deviation 21.14
|
-11.11 Unit on a scale
Standard Deviation 29.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C25D1
|
-7.14 Unit on a scale
Standard Deviation 18.39
|
-9.72 Unit on a scale
Standard Deviation 30.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C26D1
|
-7.69 Unit on a scale
Standard Deviation 23.68
|
-1.85 Unit on a scale
Standard Deviation 13.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C27D1
|
-7.33 Unit on a scale
Standard Deviation 18.05
|
-1.67 Unit on a scale
Standard Deviation 14.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C28D1
|
-9.52 Unit on a scale
Standard Deviation 17.93
|
-1.52 Unit on a scale
Standard Deviation 11.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C29D1
|
-10.61 Unit on a scale
Standard Deviation 18.22
|
-1.39 Unit on a scale
Standard Deviation 8.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C30D1
|
-9.17 Unit on a scale
Standard Deviation 21.95
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C15D1
|
-8.50 Unit on a scale
Standard Deviation 21.95
|
-0.93 Unit on a scale
Standard Deviation 9.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C31D1
|
-12.50 Unit on a scale
Standard Deviation 19.40
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C32D1
|
-11.11 Unit on a scale
Standard Deviation 19.80
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C33D1
|
-10.00 Unit on a scale
Standard Deviation 15.17
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C34D1
|
-16.67 Unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C35D1
|
-17.95 Unit on a scale
Standard Deviation 20.93
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C36D1
|
-18.06 Unit on a scale
Standard Deviation 24.06
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C37D1
|
-10.61 Unit on a scale
Standard Deviation 15.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C38D1
|
-11.67 Unit on a scale
Standard Deviation 15.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia C39D1
|
-16.67 Unit on a scale
Standard Deviation 14.43
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia 30 day follow up
|
1.75 Unit on a scale
Standard Deviation 29.66
|
2.19 Unit on a scale
Standard Deviation 27.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Odynophagia 90 day follow up
|
-0.27 Unit on a scale
Standard Deviation 18.63
|
-0.21 Unit on a scale
Standard Deviation 23.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort Baseline
|
23.53 Unit on a scale
Standard Deviation 23.88
|
25.38 Unit on a scale
Standard Deviation 25.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C2D1
|
-4.25 Unit on a scale
Standard Deviation 23.38
|
-6.94 Unit on a scale
Standard Deviation 24.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C3D1
|
-6.59 Unit on a scale
Standard Deviation 22.14
|
-8.25 Unit on a scale
Standard Deviation 21.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C4D1
|
-7.33 Unit on a scale
Standard Deviation 24.99
|
-11.34 Unit on a scale
Standard Deviation 24.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C5D1
|
-7.44 Unit on a scale
Standard Deviation 20.43
|
-11.41 Unit on a scale
Standard Deviation 26.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C6D1
|
-5.82 Unit on a scale
Standard Deviation 25.48
|
-9.31 Unit on a scale
Standard Deviation 27.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C7D1
|
-8.54 Unit on a scale
Standard Deviation 23.95
|
-9.20 Unit on a scale
Standard Deviation 24.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C16D1
|
-6.94 Unit on a scale
Standard Deviation 18.14
|
-1.08 Unit on a scale
Standard Deviation 16.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C8D1
|
-7.10 Unit on a scale
Standard Deviation 23.04
|
-9.94 Unit on a scale
Standard Deviation 25.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C9D1
|
-5.07 Unit on a scale
Standard Deviation 24.57
|
-8.09 Unit on a scale
Standard Deviation 26.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C17D1
|
-6.20 Unit on a scale
Standard Deviation 19.59
|
0.00 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C32D1
|
-10.19 Unit on a scale
Standard Deviation 32.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C33D1
|
-4.44 Unit on a scale
Standard Deviation 30.52
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C34D1
|
-13.89 Unit on a scale
Standard Deviation 27.37
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C35D1
|
-10.26 Unit on a scale
Standard Deviation 25.04
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C18D1
|
-8.13 Unit on a scale
Standard Deviation 19.41
|
-3.17 Unit on a scale
Standard Deviation 14.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C19D1
|
-10.83 Unit on a scale
Standard Deviation 21.86
|
-1.67 Unit on a scale
Standard Deviation 7.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C10D1
|
-8.24 Unit on a scale
Standard Deviation 26.80
|
-8.23 Unit on a scale
Standard Deviation 28.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C20D1
|
-8.55 Unit on a scale
Standard Deviation 19.82
|
0.00 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C36D1
|
-12.50 Unit on a scale
Standard Deviation 26.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C37D1
|
-25.76 Unit on a scale
Standard Deviation 20.23
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C38D1
|
-18.33 Unit on a scale
Standard Deviation 22.84
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C39D1
|
-14.81 Unit on a scale
Standard Deviation 34.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C11D1
|
-7.71 Unit on a scale
Standard Deviation 30.00
|
-8.22 Unit on a scale
Standard Deviation 28.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety 30 day follow up
|
2.34 Unit on a scale
Standard Deviation 31.25
|
3.51 Unit on a scale
Standard Deviation 26.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C12D1
|
-6.44 Unit on a scale
Standard Deviation 27.52
|
-5.85 Unit on a scale
Standard Deviation 25.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C13D1
|
-11.39 Unit on a scale
Standard Deviation 27.19
|
-8.33 Unit on a scale
Standard Deviation 29.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety 90 day follow up
|
0.27 Unit on a scale
Standard Deviation 27.47
|
-4.22 Unit on a scale
Standard Deviation 31.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C14D1
|
-9.39 Unit on a scale
Standard Deviation 25.21
|
-3.79 Unit on a scale
Standard Deviation 27.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C15D1
|
-8.82 Unit on a scale
Standard Deviation 24.12
|
-4.17 Unit on a scale
Standard Deviation 29.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C16D1
|
-12.15 Unit on a scale
Standard Deviation 24.73
|
-5.38 Unit on a scale
Standard Deviation 28.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C17D1
|
-9.69 Unit on a scale
Standard Deviation 25.00
|
-6.00 Unit on a scale
Standard Deviation 28.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C18D1
|
-11.79 Unit on a scale
Standard Deviation 22.44
|
-6.35 Unit on a scale
Standard Deviation 28.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C19D1
|
-5.83 Unit on a scale
Standard Deviation 22.82
|
-5.00 Unit on a scale
Standard Deviation 17.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C20D1
|
-5.56 Unit on a scale
Standard Deviation 19.99
|
-7.02 Unit on a scale
Standard Deviation 26.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C21D1
|
-7.41 Unit on a scale
Standard Deviation 20.10
|
-10.00 Unit on a scale
Standard Deviation 23.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others Baseline
|
10.70 Unit on a scale
Standard Deviation 21.53
|
10.51 Unit on a scale
Standard Deviation 22.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C22D1
|
-8.06 Unit on a scale
Standard Deviation 21.89
|
-5.88 Unit on a scale
Standard Deviation 31.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C23D1
|
-10.22 Unit on a scale
Standard Deviation 20.04
|
-8.33 Unit on a scale
Standard Deviation 29.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C24D1
|
-8.62 Unit on a scale
Standard Deviation 21.19
|
-8.33 Unit on a scale
Standard Deviation 29.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C25D1
|
-11.90 Unit on a scale
Standard Deviation 23.07
|
-9.72 Unit on a scale
Standard Deviation 32.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C21D1
|
-8.33 Unit on a scale
Standard Deviation 20.12
|
-3.33 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C26D1
|
-7.69 Unit on a scale
Standard Deviation 26.76
|
-1.85 Unit on a scale
Standard Deviation 28.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C27D1
|
-12.00 Unit on a scale
Standard Deviation 21.79
|
-3.33 Unit on a scale
Standard Deviation 15.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C28D1
|
-11.90 Unit on a scale
Standard Deviation 22.45
|
3.03 Unit on a scale
Standard Deviation 22.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C29D1
|
-12.88 Unit on a scale
Standard Deviation 21.16
|
-1.39 Unit on a scale
Standard Deviation 11.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C30D1
|
-10.83 Unit on a scale
Standard Deviation 24.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C31D1
|
-15.00 Unit on a scale
Standard Deviation 22.23
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C32D1
|
-17.59 Unit on a scale
Standard Deviation 18.50
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C33D1
|
-13.33 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C34D1
|
-20.83 Unit on a scale
Standard Deviation 23.70
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C35D1
|
-21.79 Unit on a scale
Standard Deviation 21.93
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C36D1
|
-19.44 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C37D1
|
-13.64 Unit on a scale
Standard Deviation 20.84
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C38D1
|
-13.33 Unit on a scale
Standard Deviation 33.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort C39D1
|
-22.22 Unit on a scale
Standard Deviation 18.63
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort 30 day follow up
|
0.88 Unit on a scale
Standard Deviation 29.45
|
1.32 Unit on a scale
Standard Deviation 27.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Pain and Discomfort 90 day follow up
|
-1.37 Unit on a scale
Standard Deviation 26.75
|
-2.95 Unit on a scale
Standard Deviation 23.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety Baseline
|
38.96 Unit on a scale
Standard Deviation 28.31
|
42.05 Unit on a scale
Standard Deviation 28.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C2D1
|
-3.93 Unit on a scale
Standard Deviation 25.15
|
-7.02 Unit on a scale
Standard Deviation 25.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C3D1
|
-3.02 Unit on a scale
Standard Deviation 24.93
|
-6.04 Unit on a scale
Standard Deviation 25.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C4D1
|
-4.12 Unit on a scale
Standard Deviation 24.65
|
-7.20 Unit on a scale
Standard Deviation 26.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C5D1
|
-2.73 Unit on a scale
Standard Deviation 26.24
|
-6.77 Unit on a scale
Standard Deviation 27.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Anxiety C6D1
|
-6.04 Unit on a scale
Standard Deviation 23.43
|
-8.51 Unit on a scale
Standard Deviation 29.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C25D1
|
-2.38 Unit on a scale
Standard Deviation 20.14
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C3D1
|
-2.01 Unit on a scale
Standard Deviation 18.26
|
-3.06 Unit on a scale
Standard Deviation 19.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C26D1
|
-6.41 Unit on a scale
Standard Deviation 18.90
|
-3.70 Unit on a scale
Standard Deviation 11.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C4D1
|
-3.01 Unit on a scale
Standard Deviation 16.34
|
-7.10 Unit on a scale
Standard Deviation 21.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C5D1
|
-1.68 Unit on a scale
Standard Deviation 15.82
|
-5.45 Unit on a scale
Standard Deviation 23.37
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C6D1
|
-0.22 Unit on a scale
Standard Deviation 15.25
|
-4.83 Unit on a scale
Standard Deviation 21.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C8D1
|
-2.47 Unit on a scale
Standard Deviation 18.63
|
-5.81 Unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C9D1
|
-1.63 Unit on a scale
Standard Deviation 21.69
|
-5.50 Unit on a scale
Standard Deviation 21.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C10D1
|
-2.35 Unit on a scale
Standard Deviation 23.45
|
-6.33 Unit on a scale
Standard Deviation 20.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C28D1
|
-4.76 Unit on a scale
Standard Deviation 26.43
|
-3.03 Unit on a scale
Standard Deviation 10.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C29D1
|
-9.09 Unit on a scale
Standard Deviation 21.04
|
2.78 Unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C30D1
|
-6.67 Unit on a scale
Standard Deviation 23.20
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C31D1
|
-10.00 Unit on a scale
Standard Deviation 21.90
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C32D1
|
-7.41 Unit on a scale
Standard Deviation 24.40
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others 30 day follow up
|
2.92 Unit on a scale
Standard Deviation 23.81
|
1.75 Unit on a scale
Standard Deviation 24.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C33D1
|
-8.89 Unit on a scale
Standard Deviation 23.46
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C34D1
|
-16.67 Unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C22D1
|
-6.45 Unit on a scale
Standard Deviation 18.09
|
-3.92 Unit on a scale
Standard Deviation 16.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C23D1
|
-7.53 Unit on a scale
Standard Deviation 18.68
|
-6.25 Unit on a scale
Standard Deviation 18.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C24D1
|
-3.45 Unit on a scale
Standard Deviation 18.57
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C9D1
|
1.31 Unit on a scale
Standard Deviation 24.34
|
-0.97 Unit on a scale
Standard Deviation 24.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C11D1
|
-5.00 Unit on a scale
Standard Deviation 26.57
|
0.94 Unit on a scale
Standard Deviation 26.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C12D1
|
-3.56 Unit on a scale
Standard Deviation 29.29
|
-2.34 Unit on a scale
Standard Deviation 22.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C14D1
|
-6.06 Unit on a scale
Standard Deviation 27.29
|
-2.27 Unit on a scale
Standard Deviation 25.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C15D1
|
-5.88 Unit on a scale
Standard Deviation 28.83
|
-0.93 Unit on a scale
Standard Deviation 28.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C16D1
|
-7.64 Unit on a scale
Standard Deviation 27.71
|
1.08 Unit on a scale
Standard Deviation 26.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C17D1
|
-6.20 Unit on a scale
Standard Deviation 27.46
|
-2.67 Unit on a scale
Standard Deviation 23.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C18D1
|
-8.13 Unit on a scale
Standard Deviation 25.58
|
-4.76 Unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C19D1
|
-6.67 Unit on a scale
Standard Deviation 24.11
|
-1.67 Unit on a scale
Standard Deviation 13.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C21D1
|
-9.26 Unit on a scale
Standard Deviation 20.49
|
-8.33 Unit on a scale
Standard Deviation 23.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C23D1
|
-8.60 Unit on a scale
Standard Deviation 19.18
|
-8.33 Unit on a scale
Standard Deviation 28.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C24D1
|
-8.05 Unit on a scale
Standard Deviation 17.03
|
-5.56 Unit on a scale
Standard Deviation 34.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C25D1
|
-8.33 Unit on a scale
Standard Deviation 23.35
|
-2.78 Unit on a scale
Standard Deviation 33.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C26D1
|
-6.41 Unit on a scale
Standard Deviation 23.13
|
3.70 Unit on a scale
Standard Deviation 11.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C27D1
|
-6.67 Unit on a scale
Standard Deviation 19.25
|
3.33 Unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C28D1
|
-9.52 Unit on a scale
Standard Deviation 21.46
|
6.06 Unit on a scale
Standard Deviation 13.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C29D1
|
-9.09 Unit on a scale
Standard Deviation 25.58
|
5.56 Unit on a scale
Standard Deviation 12.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C30D1
|
-3.33 Unit on a scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C31D1
|
-10.00 Unit on a scale
Standard Deviation 21.90
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C32D1
|
-11.11 Unit on a scale
Standard Deviation 22.87
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C33D1
|
-15.56 Unit on a scale
Standard Deviation 24.77
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C34D1
|
-13.89 Unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C35D1
|
-10.26 Unit on a scale
Standard Deviation 16.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C36D1
|
-11.11 Unit on a scale
Standard Deviation 16.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C37D1
|
-15.15 Unit on a scale
Standard Deviation 17.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C35D1
|
-5.13 Unit on a scale
Standard Deviation 22.96
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C36D1
|
-11.11 Unit on a scale
Standard Deviation 21.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Eating in Front of Others C37D1
|
-12.12 Unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C3D1
|
0.00 Unit on a scale
Standard Deviation 13.57
|
-1.19 Unit on a scale
Standard Deviation 15.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C4D1
|
0.20 Unit on a scale
Standard Deviation 16.20
|
-0.59 Unit on a scale
Standard Deviation 16.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C5D1
|
0.21 Unit on a scale
Standard Deviation 15.23
|
-2.63 Unit on a scale
Standard Deviation 16.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C6D1
|
2.91 Unit on a scale
Standard Deviation 18.96
|
0.00 Unit on a scale
Standard Deviation 18.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C7D1
|
1.40 Unit on a scale
Standard Deviation 18.61
|
-1.33 Unit on a scale
Standard Deviation 18.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C8D1
|
-0.62 Unit on a scale
Standard Deviation 15.77
|
-3.06 Unit on a scale
Standard Deviation 16.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C9D1
|
0.65 Unit on a scale
Standard Deviation 15.54
|
-3.56 Unit on a scale
Standard Deviation 19.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C10D1
|
0.78 Unit on a scale
Standard Deviation 17.04
|
-4.22 Unit on a scale
Standard Deviation 20.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C11D1
|
-0.42 Unit on a scale
Standard Deviation 13.52
|
-4.69 Unit on a scale
Standard Deviation 18.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C12D1
|
0.00 Unit on a scale
Standard Deviation 10.96
|
-4.68 Unit on a scale
Standard Deviation 19.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C13D1
|
0.00 Unit on a scale
Standard Deviation 12.27
|
-2.78 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C14D1
|
-1.21 Unit on a scale
Standard Deviation 11.04
|
-3.79 Unit on a scale
Standard Deviation 25.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C15D1
|
-1.96 Unit on a scale
Standard Deviation 14.00
|
-6.48 Unit on a scale
Standard Deviation 23.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C16D1
|
0.00 Unit on a scale
Standard Deviation 16.84
|
-4.30 Unit on a scale
Standard Deviation 20.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C17D1
|
-2.33 Unit on a scale
Standard Deviation 13.40
|
-6.67 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C18D1
|
-2.44 Unit on a scale
Standard Deviation 13.72
|
-6.35 Unit on a scale
Standard Deviation 22.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C19D1
|
-0.83 Unit on a scale
Standard Deviation 15.99
|
-5.00 Unit on a scale
Standard Deviation 16.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C20D1
|
-3.42 Unit on a scale
Standard Deviation 16.75
|
-7.02 Unit on a scale
Standard Deviation 23.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C21D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
-5.00 Unit on a scale
Standard Deviation 27.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C22D1
|
0.00 Unit on a scale
Standard Deviation 12.17
|
-5.88 Unit on a scale
Standard Deviation 24.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C23D1
|
0.00 Unit on a scale
Standard Deviation 12.17
|
-10.42 Unit on a scale
Standard Deviation 23.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C24D1
|
0.00 Unit on a scale
Standard Deviation 12.60
|
-8.33 Unit on a scale
Standard Deviation 20.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C25D1
|
1.19 Unit on a scale
Standard Deviation 14.29
|
-13.89 Unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C26D1
|
-1.28 Unit on a scale
Standard Deviation 11.47
|
-11.11 Unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C27D1
|
0.00 Unit on a scale
Standard Deviation 13.61
|
-10.00 Unit on a scale
Standard Deviation 22.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C28D1
|
0.00 Unit on a scale
Standard Deviation 10.54
|
-9.09 Unit on a scale
Standard Deviation 21.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C30D1
|
0.00 Unit on a scale
Standard Deviation 10.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C31D1
|
0.00 Unit on a scale
Standard Deviation 10.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C32D1
|
-1.85 Unit on a scale
Standard Deviation 7.86
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C33D1
|
-2.22 Unit on a scale
Standard Deviation 8.61
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C34D1
|
0.00 Unit on a scale
Standard Deviation 14.21
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C35D1
|
0.00 Unit on a scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C36D1
|
-2.78 Unit on a scale
Standard Deviation 9.62
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C37D1
|
0.00 Unit on a scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C38D1
|
0.00 Unit on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C39D1
|
0.00 Unit on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva 30 day follow up
|
1.75 Unit on a scale
Standard Deviation 20.34
|
-1.75 Unit on a scale
Standard Deviation 17.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva 90 day follow up
|
1.64 Unit on a scale
Standard Deviation 16.58
|
-2.95 Unit on a scale
Standard Deviation 21.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing Baseline
|
5.35 Unit on a scale
Standard Deviation 14.01
|
6.64 Unit on a scale
Standard Deviation 17.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C2D1
|
-1.60 Unit on a scale
Standard Deviation 13.81
|
-1.54 Unit on a scale
Standard Deviation 15.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C3D1
|
-1.10 Unit on a scale
Standard Deviation 12.09
|
-1.87 Unit on a scale
Standard Deviation 17.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C4D1
|
-2.01 Unit on a scale
Standard Deviation 14.07
|
-1.38 Unit on a scale
Standard Deviation 16.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C5D1
|
-1.68 Unit on a scale
Standard Deviation 15.82
|
-2.42 Unit on a scale
Standard Deviation 17.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C6D1
|
-1.12 Unit on a scale
Standard Deviation 15.70
|
-1.84 Unit on a scale
Standard Deviation 18.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C7D1
|
0.56 Unit on a scale
Standard Deviation 19.40
|
-2.93 Unit on a scale
Standard Deviation 19.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C8D1
|
-0.31 Unit on a scale
Standard Deviation 14.76
|
-3.67 Unit on a scale
Standard Deviation 18.89
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C9D1
|
-0.65 Unit on a scale
Standard Deviation 14.82
|
-2.27 Unit on a scale
Standard Deviation 19.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C10D1
|
-1.96 Unit on a scale
Standard Deviation 14.87
|
-2.95 Unit on a scale
Standard Deviation 19.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C11D1
|
-0.83 Unit on a scale
Standard Deviation 14.98
|
-2.82 Unit on a scale
Standard Deviation 18.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C12D1
|
-2.22 Unit on a scale
Standard Deviation 14.84
|
-1.75 Unit on a scale
Standard Deviation 15.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C13D1
|
-3.33 Unit on a scale
Standard Deviation 14.65
|
-4.17 Unit on a scale
Standard Deviation 18.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C14D1
|
-3.03 Unit on a scale
Standard Deviation 11.61
|
-1.52 Unit on a scale
Standard Deviation 21.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C16D1
|
-2.08 Unit on a scale
Standard Deviation 12.69
|
1.08 Unit on a scale
Standard Deviation 21.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C17D1
|
-1.55 Unit on a scale
Standard Deviation 7.10
|
-4.00 Unit on a scale
Standard Deviation 22.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C18D1
|
-0.81 Unit on a scale
Standard Deviation 11.76
|
-3.17 Unit on a scale
Standard Deviation 17.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C19D1
|
-1.67 Unit on a scale
Standard Deviation 10.54
|
-1.67 Unit on a scale
Standard Deviation 7.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C20D1
|
-2.56 Unit on a scale
Standard Deviation 11.81
|
-3.51 Unit on a scale
Standard Deviation 18.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C21D1
|
-1.85 Unit on a scale
Standard Deviation 15.83
|
-5.00 Unit on a scale
Standard Deviation 16.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C22D1
|
-2.15 Unit on a scale
Standard Deviation 11.97
|
-3.92 Unit on a scale
Standard Deviation 20.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C23D1
|
-2.15 Unit on a scale
Standard Deviation 14.75
|
-4.17 Unit on a scale
Standard Deviation 20.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C24D1
|
-1.15 Unit on a scale
Standard Deviation 14.04
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C25D1
|
-3.57 Unit on a scale
Standard Deviation 13.88
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C26D1
|
-2.56 Unit on a scale
Standard Deviation 13.07
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C27D1
|
-1.33 Unit on a scale
Standard Deviation 17.95
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C28D1
|
0.00 Unit on a scale
Standard Deviation 18.26
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C29D1
|
1.52 Unit on a scale
Standard Deviation 16.19
|
-2.78 Unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C30D1
|
3.33 Unit on a scale
Standard Deviation 18.42
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C31D1
|
1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C32D1
|
0.00 Unit on a scale
Standard Deviation 19.80
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C33D1
|
-2.22 Unit on a scale
Standard Deviation 15.26
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C34D1
|
0.00 Unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C35D1
|
2.56 Unit on a scale
Standard Deviation 21.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C3D1
|
-0.55 Unit on a scale
Standard Deviation 23.89
|
4.93 Unit on a scale
Standard Deviation 26.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C37D1
|
-3.03 Unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing C39D1
|
0.00 Unit on a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Choked When Swallowing 30 day follow up
|
4.09 Unit on a scale
Standard Deviation 21.89
|
-3.07 Unit on a scale
Standard Deviation 19.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing Baseline
|
10.56 Unit on a scale
Standard Deviation 17.49
|
9.82 Unit on a scale
Standard Deviation 19.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C2D1
|
-0.48 Unit on a scale
Standard Deviation 16.86
|
-0.77 Unit on a scale
Standard Deviation 18.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C3D1
|
-2.01 Unit on a scale
Standard Deviation 17.92
|
-0.68 Unit on a scale
Standard Deviation 19.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C4D1
|
-1.61 Unit on a scale
Standard Deviation 19.00
|
-0.99 Unit on a scale
Standard Deviation 20.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C5D1
|
0.21 Unit on a scale
Standard Deviation 19.30
|
-2.63 Unit on a scale
Standard Deviation 18.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C6D1
|
0.22 Unit on a scale
Standard Deviation 23.41
|
-1.38 Unit on a scale
Standard Deviation 16.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C7D1
|
-2.24 Unit on a scale
Standard Deviation 19.76
|
-1.87 Unit on a scale
Standard Deviation 19.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C8D1
|
-0.31 Unit on a scale
Standard Deviation 17.94
|
-1.22 Unit on a scale
Standard Deviation 20.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C9D1
|
-3.92 Unit on a scale
Standard Deviation 20.06
|
-2.91 Unit on a scale
Standard Deviation 21.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C10D1
|
-3.53 Unit on a scale
Standard Deviation 22.43
|
-2.11 Unit on a scale
Standard Deviation 25.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C11D1
|
-4.17 Unit on a scale
Standard Deviation 22.73
|
-4.23 Unit on a scale
Standard Deviation 25.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C13D1
|
-5.00 Unit on a scale
Standard Deviation 25.91
|
-6.94 Unit on a scale
Standard Deviation 22.76
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C14D1
|
-6.06 Unit on a scale
Standard Deviation 15.83
|
-6.82 Unit on a scale
Standard Deviation 23.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C15D1
|
-7.19 Unit on a scale
Standard Deviation 20.35
|
-7.41 Unit on a scale
Standard Deviation 21.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C16D1
|
-4.17 Unit on a scale
Standard Deviation 23.44
|
-8.60 Unit on a scale
Standard Deviation 19.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C17D1
|
-7.75 Unit on a scale
Standard Deviation 22.81
|
1.33 Unit on a scale
Standard Deviation 17.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C18D1
|
-6.50 Unit on a scale
Standard Deviation 21.37
|
-4.76 Unit on a scale
Standard Deviation 19.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C19D1
|
-5.00 Unit on a scale
Standard Deviation 17.78
|
-1.67 Unit on a scale
Standard Deviation 7.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C21D1
|
-4.63 Unit on a scale
Standard Deviation 19.76
|
-1.67 Unit on a scale
Standard Deviation 20.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C22D1
|
-5.38 Unit on a scale
Standard Deviation 17.42
|
-5.88 Unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C23D1
|
-4.30 Unit on a scale
Standard Deviation 18.74
|
-6.25 Unit on a scale
Standard Deviation 21.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C24D1
|
-3.45 Unit on a scale
Standard Deviation 18.57
|
-5.56 Unit on a scale
Standard Deviation 23.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C25D1
|
-2.38 Unit on a scale
Standard Deviation 17.98
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C26D1
|
-1.28 Unit on a scale
Standard Deviation 17.59
|
-3.70 Unit on a scale
Standard Deviation 20.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C27D1
|
-4.00 Unit on a scale
Standard Deviation 17.53
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C28D1
|
-1.59 Unit on a scale
Standard Deviation 12.81
|
0.00 Unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C29D1
|
3.03 Unit on a scale
Standard Deviation 22.79
|
-2.78 Unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C30D1
|
1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C31D1
|
3.33 Unit on a scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image 30 day follow up
|
3.51 Unit on a scale
Standard Deviation 30.00
|
5.26 Unit on a scale
Standard Deviation 26.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C32D1
|
3.70 Unit on a scale
Standard Deviation 19.43
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C33D1
|
-4.44 Unit on a scale
Standard Deviation 11.73
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C34D1
|
0.00 Unit on a scale
Standard Deviation 14.21
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C8D1
|
-1.85 Unit on a scale
Standard Deviation 25.71
|
3.98 Unit on a scale
Standard Deviation 29.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C9D1
|
0.00 Unit on a scale
Standard Deviation 28.92
|
2.27 Unit on a scale
Standard Deviation 28.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C10D1
|
-5.88 Unit on a scale
Standard Deviation 28.72
|
-2.11 Unit on a scale
Standard Deviation 27.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C12D1
|
-5.78 Unit on a scale
Standard Deviation 26.49
|
1.17 Unit on a scale
Standard Deviation 25.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C13D1
|
-5.00 Unit on a scale
Standard Deviation 26.63
|
-2.08 Unit on a scale
Standard Deviation 27.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C14D1
|
-7.27 Unit on a scale
Standard Deviation 26.21
|
-2.27 Unit on a scale
Standard Deviation 26.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C15D1
|
-5.88 Unit on a scale
Standard Deviation 24.68
|
0.00 Unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C16D1
|
-7.64 Unit on a scale
Standard Deviation 25.02
|
1.08 Unit on a scale
Standard Deviation 16.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C17D1
|
-6.20 Unit on a scale
Standard Deviation 19.59
|
4.00 Unit on a scale
Standard Deviation 17.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C18D1
|
-5.69 Unit on a scale
Standard Deviation 19.58
|
4.76 Unit on a scale
Standard Deviation 15.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C19D1
|
-9.17 Unit on a scale
Standard Deviation 25.02
|
3.33 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C20D1
|
-8.55 Unit on a scale
Standard Deviation 21.24
|
3.51 Unit on a scale
Standard Deviation 24.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C21D1
|
-5.56 Unit on a scale
Standard Deviation 24.56
|
3.33 Unit on a scale
Standard Deviation 18.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C22D1
|
-9.68 Unit on a scale
Standard Deviation 23.08
|
7.84 Unit on a scale
Standard Deviation 18.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C23D1
|
-7.53 Unit on a scale
Standard Deviation 23.90
|
2.08 Unit on a scale
Standard Deviation 14.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C24D1
|
-6.90 Unit on a scale
Standard Deviation 24.20
|
5.56 Unit on a scale
Standard Deviation 27.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C25D1
|
-10.71 Unit on a scale
Standard Deviation 22.32
|
2.78 Unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C26D1
|
-8.97 Unit on a scale
Standard Deviation 27.58
|
0.00 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C27D1
|
-6.67 Unit on a scale
Standard Deviation 21.52
|
3.33 Unit on a scale
Standard Deviation 18.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C28D1
|
-4.76 Unit on a scale
Standard Deviation 26.43
|
0.00 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C29D1
|
-6.06 Unit on a scale
Standard Deviation 28.43
|
-2.78 Unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C30D1
|
-5.00 Unit on a scale
Standard Deviation 24.84
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C31D1
|
-8.33 Unit on a scale
Standard Deviation 28.36
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C32D1
|
-11.11 Unit on a scale
Standard Deviation 30.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C33D1
|
-15.56 Unit on a scale
Standard Deviation 21.33
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C34D1
|
-22.22 Unit on a scale
Standard Deviation 21.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C35D1
|
-17.95 Unit on a scale
Standard Deviation 25.88
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C36D1
|
-16.67 Unit on a scale
Standard Deviation 17.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C37D1
|
-18.18 Unit on a scale
Standard Deviation 31.14
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C38D1
|
-20.00 Unit on a scale
Standard Deviation 32.20
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth C39D1
|
-22.22 Unit on a scale
Standard Deviation 33.33
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth 30 day follow up
|
-4.68 Unit on a scale
Standard Deviation 26.31
|
5.70 Unit on a scale
Standard Deviation 26.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Dry Mouth 90 day follow up
|
3.83 Unit on a scale
Standard Deviation 25.16
|
6.75 Unit on a scale
Standard Deviation 28.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste Baseline
|
9.47 Unit on a scale
Standard Deviation 21.58
|
7.47 Unit on a scale
Standard Deviation 18.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C3D1
|
7.33 Unit on a scale
Standard Deviation 25.41
|
5.27 Unit on a scale
Standard Deviation 20.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C4D1
|
5.62 Unit on a scale
Standard Deviation 24.24
|
5.52 Unit on a scale
Standard Deviation 24.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C5D1
|
8.18 Unit on a scale
Standard Deviation 26.71
|
8.08 Unit on a scale
Standard Deviation 25.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C6D1
|
12.30 Unit on a scale
Standard Deviation 27.77
|
11.72 Unit on a scale
Standard Deviation 27.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C7D1
|
10.92 Unit on a scale
Standard Deviation 28.82
|
9.33 Unit on a scale
Standard Deviation 25.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C8D1
|
10.49 Unit on a scale
Standard Deviation 25.23
|
10.40 Unit on a scale
Standard Deviation 28.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C9D1
|
8.17 Unit on a scale
Standard Deviation 29.83
|
6.47 Unit on a scale
Standard Deviation 25.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C10D1
|
7.06 Unit on a scale
Standard Deviation 29.59
|
2.95 Unit on a scale
Standard Deviation 26.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C11D1
|
2.92 Unit on a scale
Standard Deviation 27.14
|
4.23 Unit on a scale
Standard Deviation 26.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C12D1
|
2.22 Unit on a scale
Standard Deviation 26.47
|
0.00 Unit on a scale
Standard Deviation 21.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C13D1
|
0.56 Unit on a scale
Standard Deviation 32.18
|
3.47 Unit on a scale
Standard Deviation 19.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C14D1
|
1.82 Unit on a scale
Standard Deviation 25.99
|
1.52 Unit on a scale
Standard Deviation 22.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C15D1
|
0.00 Unit on a scale
Standard Deviation 27.49
|
1.85 Unit on a scale
Standard Deviation 23.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C16D1
|
1.39 Unit on a scale
Standard Deviation 25.69
|
3.23 Unit on a scale
Standard Deviation 15.76
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C17D1
|
1.55 Unit on a scale
Standard Deviation 24.07
|
8.00 Unit on a scale
Standard Deviation 14.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C18D1
|
0.81 Unit on a scale
Standard Deviation 24.14
|
4.76 Unit on a scale
Standard Deviation 11.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C19D1
|
0.83 Unit on a scale
Standard Deviation 21.99
|
1.67 Unit on a scale
Standard Deviation 7.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C20D1
|
2.56 Unit on a scale
Standard Deviation 22.14
|
7.02 Unit on a scale
Standard Deviation 13.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C21D1
|
-0.93 Unit on a scale
Standard Deviation 24.54
|
10.00 Unit on a scale
Standard Deviation 15.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C22D1
|
-1.08 Unit on a scale
Standard Deviation 26.50
|
5.88 Unit on a scale
Standard Deviation 13.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C23D1
|
2.15 Unit on a scale
Standard Deviation 24.24
|
8.33 Unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C24D1
|
0.00 Unit on a scale
Standard Deviation 19.92
|
2.78 Unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C25D1
|
2.38 Unit on a scale
Standard Deviation 20.14
|
5.56 Unit on a scale
Standard Deviation 12.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C26D1
|
-1.28 Unit on a scale
Standard Deviation 19.96
|
11.11 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C27D1
|
0.00 Unit on a scale
Standard Deviation 19.25
|
3.33 Unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C28D1
|
3.17 Unit on a scale
Standard Deviation 23.34
|
3.03 Unit on a scale
Standard Deviation 10.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C29D1
|
4.55 Unit on a scale
Standard Deviation 21.32
|
8.33 Unit on a scale
Standard Deviation 15.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C30D1
|
1.67 Unit on a scale
Standard Deviation 20.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C31D1
|
1.67 Unit on a scale
Standard Deviation 22.88
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C32D1
|
0.00 Unit on a scale
Standard Deviation 22.87
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C33D1
|
-2.22 Unit on a scale
Standard Deviation 23.46
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C34D1
|
-8.33 Unit on a scale
Standard Deviation 20.72
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C35D1
|
-2.56 Unit on a scale
Standard Deviation 21.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C36D1
|
-2.78 Unit on a scale
Standard Deviation 22.29
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C37D1
|
-3.03 Unit on a scale
Standard Deviation 27.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C38D1
|
-3.33 Unit on a scale
Standard Deviation 29.19
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste C39D1
|
0.00 Unit on a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste 30 day follow up
|
4.09 Unit on a scale
Standard Deviation 23.63
|
9.21 Unit on a scale
Standard Deviation 29.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Taste 90 day follow up
|
7.65 Unit on a scale
Standard Deviation 25.38
|
7.59 Unit on a scale
Standard Deviation 22.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image Baseline
|
17.97 Unit on a scale
Standard Deviation 25.75
|
19.64 Unit on a scale
Standard Deviation 23.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C2D1
|
-0.80 Unit on a scale
Standard Deviation 22.80
|
-2.31 Unit on a scale
Standard Deviation 22.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C3D1
|
1.47 Unit on a scale
Standard Deviation 24.48
|
-1.53 Unit on a scale
Standard Deviation 23.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C4D1
|
1.00 Unit on a scale
Standard Deviation 26.32
|
-0.99 Unit on a scale
Standard Deviation 22.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C5D1
|
2.52 Unit on a scale
Standard Deviation 28.45
|
0.61 Unit on a scale
Standard Deviation 22.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Body Image C7D1
|
0.28 Unit on a scale
Standard Deviation 25.85
|
-0.80 Unit on a scale
Standard Deviation 25.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva Baseline
|
3.84 Unit on a scale
Standard Deviation 12.64
|
5.26 Unit on a scale
Standard Deviation 15.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Swallowing Saliva C2D1
|
0.48 Unit on a scale
Standard Deviation 13.70
|
-1.85 Unit on a scale
Standard Deviation 14.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C36D1
|
-5.56 Unit on a scale
Standard Deviation 12.97
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C37D1
|
-6.06 Unit on a scale
Standard Deviation 13.48
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C38D1
|
0.00 Unit on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing C39D1
|
3.70 Unit on a scale
Standard Deviation 11.11
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble with Coughing 90 day follow up
|
2.19 Unit on a scale
Standard Deviation 15.95
|
1.27 Unit on a scale
Standard Deviation 25.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking Baseline
|
3.84 Unit on a scale
Standard Deviation 14.34
|
3.60 Unit on a scale
Standard Deviation 12.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C2D1
|
0.96 Unit on a scale
Standard Deviation 13.07
|
-0.31 Unit on a scale
Standard Deviation 9.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C3D1
|
-0.18 Unit on a scale
Standard Deviation 11.35
|
-1.02 Unit on a scale
Standard Deviation 11.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C4D1
|
-0.40 Unit on a scale
Standard Deviation 12.71
|
0.99 Unit on a scale
Standard Deviation 14.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C5D1
|
1.68 Unit on a scale
Standard Deviation 11.74
|
-0.81 Unit on a scale
Standard Deviation 11.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C6D1
|
0.67 Unit on a scale
Standard Deviation 13.68
|
0.46 Unit on a scale
Standard Deviation 11.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C7D1
|
0.84 Unit on a scale
Standard Deviation 15.32
|
-0.53 Unit on a scale
Standard Deviation 11.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C8D1
|
0.93 Unit on a scale
Standard Deviation 12.45
|
-1.22 Unit on a scale
Standard Deviation 13.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C9D1
|
0.65 Unit on a scale
Standard Deviation 15.54
|
0.32 Unit on a scale
Standard Deviation 13.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C10D1
|
0.39 Unit on a scale
Standard Deviation 14.08
|
-1.27 Unit on a scale
Standard Deviation 15.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C11D1
|
0.42 Unit on a scale
Standard Deviation 12.43
|
-1.41 Unit on a scale
Standard Deviation 13.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C12D1
|
-1.33 Unit on a scale
Standard Deviation 11.55
|
0.58 Unit on a scale
Standard Deviation 7.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C13D1
|
-2.78 Unit on a scale
Standard Deviation 12.71
|
-1.39 Unit on a scale
Standard Deviation 15.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C14D1
|
-3.03 Unit on a scale
Standard Deviation 11.61
|
0.00 Unit on a scale
Standard Deviation 16.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C15D1
|
-3.27 Unit on a scale
Standard Deviation 13.75
|
-1.85 Unit on a scale
Standard Deviation 13.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C16D1
|
0.00 Unit on a scale
Standard Deviation 16.84
|
-1.08 Unit on a scale
Standard Deviation 16.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C17D1
|
-4.65 Unit on a scale
Standard Deviation 13.77
|
2.67 Unit on a scale
Standard Deviation 13.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C18D1
|
-3.25 Unit on a scale
Standard Deviation 12.48
|
3.17 Unit on a scale
Standard Deviation 14.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C19D1
|
0.00 Unit on a scale
Standard Deviation 15.10
|
1.67 Unit on a scale
Standard Deviation 7.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C22D1
|
-3.23 Unit on a scale
Standard Deviation 13.21
|
0.00 Unit on a scale
Standard Deviation 20.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C23D1
|
-1.08 Unit on a scale
Standard Deviation 13.56
|
-2.08 Unit on a scale
Standard Deviation 19.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C24D1
|
-2.30 Unit on a scale
Standard Deviation 12.38
|
0.00 Unit on a scale
Standard Deviation 24.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C25D1
|
-1.19 Unit on a scale
Standard Deviation 14.29
|
2.78 Unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C26D1
|
-1.28 Unit on a scale
Standard Deviation 14.85
|
3.70 Unit on a scale
Standard Deviation 11.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C27D1
|
-2.67 Unit on a scale
Standard Deviation 13.33
|
3.33 Unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C28D1
|
-3.17 Unit on a scale
Standard Deviation 14.55
|
3.03 Unit on a scale
Standard Deviation 10.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C29D1
|
-1.52 Unit on a scale
Standard Deviation 16.19
|
2.78 Unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C30D1
|
-1.67 Unit on a scale
Standard Deviation 17.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C31D1
|
0.00 Unit on a scale
Standard Deviation 18.73
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C32D1
|
-1.85 Unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C33D1
|
-4.44 Unit on a scale
Standard Deviation 17.21
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C34D1
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C35D1
|
-5.13 Unit on a scale
Standard Deviation 18.49
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C36D1
|
-5.56 Unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C37D1
|
-6.06 Unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C38D1
|
-6.67 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking C39D1
|
0.00 Unit on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking 30 day follow up
|
4.68 Unit on a scale
Standard Deviation 18.30
|
2.19 Unit on a scale
Standard Deviation 15.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Trouble Talking 90 day follow up
|
3.83 Unit on a scale
Standard Deviation 10.71
|
3.38 Unit on a scale
Standard Deviation 20.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss Baseline
|
23.05 Unit on a scale
Standard Deviation 27.43
|
24.07 Unit on a scale
Standard Deviation 28.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C2D1
|
0.16 Unit on a scale
Standard Deviation 23.28
|
0.46 Unit on a scale
Standard Deviation 26.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C3D1
|
0.92 Unit on a scale
Standard Deviation 26.78
|
1.02 Unit on a scale
Standard Deviation 27.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C4D1
|
0.00 Unit on a scale
Standard Deviation 28.19
|
-1.18 Unit on a scale
Standard Deviation 25.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C5D1
|
2.52 Unit on a scale
Standard Deviation 32.38
|
-2.42 Unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C6D1
|
-0.45 Unit on a scale
Standard Deviation 25.99
|
-5.29 Unit on a scale
Standard Deviation 29.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C7D1
|
-2.52 Unit on a scale
Standard Deviation 27.84
|
-3.47 Unit on a scale
Standard Deviation 28.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C8D1
|
-2.47 Unit on a scale
Standard Deviation 26.46
|
-3.67 Unit on a scale
Standard Deviation 29.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C9D1
|
-5.88 Unit on a scale
Standard Deviation 29.45
|
-7.12 Unit on a scale
Standard Deviation 29.76
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C10D1
|
-7.06 Unit on a scale
Standard Deviation 32.57
|
-5.91 Unit on a scale
Standard Deviation 28.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C12D1
|
-10.22 Unit on a scale
Standard Deviation 30.50
|
-10.53 Unit on a scale
Standard Deviation 24.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C13D1
|
-11.67 Unit on a scale
Standard Deviation 28.67
|
-10.42 Unit on a scale
Standard Deviation 25.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C14D1
|
-13.94 Unit on a scale
Standard Deviation 26.21
|
-6.82 Unit on a scale
Standard Deviation 23.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C15D1
|
-12.42 Unit on a scale
Standard Deviation 26.63
|
-8.33 Unit on a scale
Standard Deviation 30.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C16D1
|
-15.97 Unit on a scale
Standard Deviation 22.79
|
-8.60 Unit on a scale
Standard Deviation 22.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C17D1
|
-14.73 Unit on a scale
Standard Deviation 19.66
|
-13.33 Unit on a scale
Standard Deviation 21.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C18D1
|
-11.38 Unit on a scale
Standard Deviation 25.40
|
-14.29 Unit on a scale
Standard Deviation 27.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C19D1
|
-16.67 Unit on a scale
Standard Deviation 22.65
|
-11.67 Unit on a scale
Standard Deviation 16.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C20D1
|
-10.26 Unit on a scale
Standard Deviation 21.84
|
-12.28 Unit on a scale
Standard Deviation 25.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C21D1
|
-12.96 Unit on a scale
Standard Deviation 22.93
|
-16.67 Unit on a scale
Standard Deviation 25.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C22D1
|
-12.90 Unit on a scale
Standard Deviation 23.85
|
-17.65 Unit on a scale
Standard Deviation 26.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C23D1
|
-10.75 Unit on a scale
Standard Deviation 19.98
|
-22.92 Unit on a scale
Standard Deviation 29.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C24D1
|
-10.34 Unit on a scale
Standard Deviation 26.88
|
-13.89 Unit on a scale
Standard Deviation 30.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C25D1
|
-10.71 Unit on a scale
Standard Deviation 20.39
|
-11.11 Unit on a scale
Standard Deviation 25.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C26D1
|
-16.67 Unit on a scale
Standard Deviation 25.39
|
-11.11 Unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C27D1
|
-12.00 Unit on a scale
Standard Deviation 21.26
|
-13.33 Unit on a scale
Standard Deviation 23.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C28D1
|
-14.29 Unit on a scale
Standard Deviation 22.54
|
-6.06 Unit on a scale
Standard Deviation 13.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C30D1
|
-15.00 Unit on a scale
Standard Deviation 20.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C31D1
|
-11.67 Unit on a scale
Standard Deviation 19.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C32D1
|
-20.37 Unit on a scale
Standard Deviation 20.26
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C33D1
|
-15.56 Unit on a scale
Standard Deviation 24.77
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C34D1
|
-16.67 Unit on a scale
Standard Deviation 26.59
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C35D1
|
-15.38 Unit on a scale
Standard Deviation 22.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C36D1
|
-13.89 Unit on a scale
Standard Deviation 22.29
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C37D1
|
-18.18 Unit on a scale
Standard Deviation 27.34
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C38D1
|
-20.00 Unit on a scale
Standard Deviation 23.31
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss C39D1
|
-14.81 Unit on a scale
Standard Deviation 24.22
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss 30 day follow up
|
-1.75 Unit on a scale
Standard Deviation 30.49
|
3.95 Unit on a scale
Standard Deviation 27.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Weight Loss 90 day follow up
|
-1.64 Unit on a scale
Standard Deviation 24.67
|
2.95 Unit on a scale
Standard Deviation 30.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss Baseline
|
12.09 Unit on a scale
Standard Deviation 20.80
|
12.55 Unit on a scale
Standard Deviation 23.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C2D1
|
-2.26 Unit on a scale
Standard Deviation 18.43
|
-1.67 Unit on a scale
Standard Deviation 15.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C3D1
|
-3.09 Unit on a scale
Standard Deviation 19.71
|
-4.76 Unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C6D1
|
2.96 Unit on a scale
Standard Deviation 23.38
|
-4.63 Unit on a scale
Standard Deviation 21.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C10D1
|
-1.67 Unit on a scale
Standard Deviation 25.31
|
-8.33 Unit on a scale
Standard Deviation 28.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C11D1
|
-1.67 Unit on a scale
Standard Deviation 27.52
|
3.03 Unit on a scale
Standard Deviation 17.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C12D1
|
-4.55 Unit on a scale
Standard Deviation 25.81
|
0.00 Unit on a scale
Standard Deviation 20.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C13D1
|
-5.26 Unit on a scale
Standard Deviation 29.94
|
-6.67 Unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C14D1
|
-11.11 Unit on a scale
Standard Deviation 29.59
|
4.76 Unit on a scale
Standard Deviation 12.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C16D1
|
-2.56 Unit on a scale
Standard Deviation 16.45
|
-6.67 Unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C17D1
|
0.00 Unit on a scale
Standard Deviation 21.08
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C18D1
|
0.00 Unit on a scale
Standard Deviation 22.22
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C19D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
-13.33 Unit on a scale
Standard Deviation 18.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C20D1
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
0.00 Unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C21D1
|
-3.33 Unit on a scale
Standard Deviation 18.92
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C22D1
|
0.00 Unit on a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C23D1
|
0.00 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C24D1
|
-4.76 Unit on a scale
Standard Deviation 23.00
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss C25D1
|
0.00 Unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Hair Loss 30 day follow up
|
8.33 Unit on a scale
Standard Deviation 23.57
|
2.38 Unit on a scale
Standard Deviation 30.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching Baseline
|
12.14 Unit on a scale
Standard Deviation 18.62
|
14.11 Unit on a scale
Standard Deviation 21.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C2D1
|
-1.52 Unit on a scale
Standard Deviation 15.68
|
-3.09 Unit on a scale
Standard Deviation 14.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C4D1
|
0.20 Unit on a scale
Standard Deviation 16.51
|
-3.16 Unit on a scale
Standard Deviation 18.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C5D1
|
1.68 Unit on a scale
Standard Deviation 17.81
|
-5.35 Unit on a scale
Standard Deviation 18.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C7D1
|
0.28 Unit on a scale
Standard Deviation 17.36
|
-5.07 Unit on a scale
Standard Deviation 20.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C9D1
|
1.31 Unit on a scale
Standard Deviation 18.27
|
-9.39 Unit on a scale
Standard Deviation 20.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C13D1
|
-0.28 Unit on a scale
Standard Deviation 20.00
|
-7.64 Unit on a scale
Standard Deviation 22.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C14D1
|
0.00 Unit on a scale
Standard Deviation 17.27
|
-6.06 Unit on a scale
Standard Deviation 20.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C15D1
|
-1.31 Unit on a scale
Standard Deviation 16.61
|
-5.56 Unit on a scale
Standard Deviation 19.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C16D1
|
-2.78 Unit on a scale
Standard Deviation 18.30
|
-5.91 Unit on a scale
Standard Deviation 22.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C19D1
|
0.42 Unit on a scale
Standard Deviation 15.33
|
-2.50 Unit on a scale
Standard Deviation 11.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C22D1
|
-0.54 Unit on a scale
Standard Deviation 17.99
|
-4.90 Unit on a scale
Standard Deviation 28.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C23D1
|
-3.23 Unit on a scale
Standard Deviation 16.34
|
-9.38 Unit on a scale
Standard Deviation 23.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C25D1
|
0.60 Unit on a scale
Standard Deviation 17.26
|
-8.33 Unit on a scale
Standard Deviation 31.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C26D1
|
1.92 Unit on a scale
Standard Deviation 17.21
|
3.70 Unit on a scale
Standard Deviation 20.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C28D1
|
3.97 Unit on a scale
Standard Deviation 13.85
|
1.52 Unit on a scale
Standard Deviation 13.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C29D1
|
0.00 Unit on a scale
Standard Deviation 15.43
|
-1.39 Unit on a scale
Standard Deviation 11.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C30D1
|
0.83 Unit on a scale
Standard Deviation 14.78
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C31D1
|
2.50 Unit on a scale
Standard Deviation 16.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C32D1
|
4.63 Unit on a scale
Standard Deviation 17.90
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C33D1
|
-1.11 Unit on a scale
Standard Deviation 14.73
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C34D1
|
0.00 Unit on a scale
Standard Deviation 12.31
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C35D1
|
3.85 Unit on a scale
Standard Deviation 20.59
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C36D1
|
1.39 Unit on a scale
Standard Deviation 19.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C37D1
|
6.06 Unit on a scale
Standard Deviation 11.24
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C38D1
|
1.67 Unit on a scale
Standard Deviation 16.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching C39D1
|
3.70 Unit on a scale
Standard Deviation 7.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching 30 day follow up
|
3.22 Unit on a scale
Standard Deviation 21.23
|
0.66 Unit on a scale
Standard Deviation 19.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
Belching 90 day follow up
|
-0.55 Unit on a scale
Standard Deviation 15.20
|
-1.90 Unit on a scale
Standard Deviation 17.50
|
SECONDARY outcome
Timeframe: Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow upPopulation: FAS with available data was analyzed.
The GP instrument is a single assessment of overall pain and participants were assessed in global pain according to the following response categories: 1= no pain (anymore), 2 = less pain, 3 = no change and 4 = more pain. Low pain scores are considered a better outcome than a high pain score.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=243 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=236 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C10D1
|
-0.71 Unit on a scale
Standard Deviation 2.67
|
-0.71 Unit on a scale
Standard Deviation 2.65
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C11D1
|
-0.40 Unit on a scale
Standard Deviation 2.96
|
-0.61 Unit on a scale
Standard Deviation 2.55
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C16D1
|
-0.19 Unit on a scale
Standard Deviation 3.07
|
0.10 Unit on a scale
Standard Deviation 2.23
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C27D1
|
-1.08 Unit on a scale
Standard Deviation 2.25
|
0.80 Unit on a scale
Standard Deviation 3.29
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C30D1
|
-0.45 Unit on a scale
Standard Deviation 2.11
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C31D1
|
-0.45 Unit on a scale
Standard Deviation 2.24
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C32D1
|
-0.50 Unit on a scale
Standard Deviation 2.71
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C33D1
|
0.07 Unit on a scale
Standard Deviation 3.24
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C34D1
|
-0.67 Unit on a scale
Standard Deviation 3.20
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
90 day follow up
|
0.08 Unit on a scale
Standard Deviation 3.34
|
0.62 Unit on a scale
Standard Deviation 2.81
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
Baseline
|
2.45 Unit on a scale
Standard Deviation 2.49
|
2.64 Unit on a scale
Standard Deviation 2.55
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C5D1
|
-0.37 Unit on a scale
Standard Deviation 2.89
|
-0.79 Unit on a scale
Standard Deviation 2.84
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C6D1
|
-0.51 Unit on a scale
Standard Deviation 2.61
|
-0.57 Unit on a scale
Standard Deviation 3.00
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C7D1
|
-0.61 Unit on a scale
Standard Deviation 2.65
|
-0.38 Unit on a scale
Standard Deviation 2.74
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C8D1
|
-0.59 Unit on a scale
Standard Deviation 2.45
|
-0.36 Unit on a scale
Standard Deviation 2.48
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C9D1
|
-0.65 Unit on a scale
Standard Deviation 2.62
|
-0.36 Unit on a scale
Standard Deviation 2.63
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C12D1
|
0.08 Unit on a scale
Standard Deviation 2.91
|
-0.53 Unit on a scale
Standard Deviation 2.41
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C13D1
|
0.05 Unit on a scale
Standard Deviation 3.40
|
-0.63 Unit on a scale
Standard Deviation 2.44
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C14D1
|
-0.95 Unit on a scale
Standard Deviation 2.63
|
-0.34 Unit on a scale
Standard Deviation 2.12
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C15D1
|
-0.80 Unit on a scale
Standard Deviation 2.62
|
-0.44 Unit on a scale
Standard Deviation 1.81
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C17D1
|
-0.74 Unit on a scale
Standard Deviation 2.46
|
-0.20 Unit on a scale
Standard Deviation 1.32
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C18D1
|
0.17 Unit on a scale
Standard Deviation 3.26
|
-0.48 Unit on a scale
Standard Deviation 1.29
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C19D1
|
-0.20 Unit on a scale
Standard Deviation 2.53
|
-0.25 Unit on a scale
Standard Deviation 0.97
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C20D1
|
0.05 Unit on a scale
Standard Deviation 2.72
|
0.21 Unit on a scale
Standard Deviation 2.90
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C21D1
|
-0.06 Unit on a scale
Standard Deviation 2.86
|
0.50 Unit on a scale
Standard Deviation 2.96
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C22D1
|
0.00 Unit on a scale
Standard Deviation 2.89
|
0.00 Unit on a scale
Standard Deviation 2.92
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C23D1
|
-0.19 Unit on a scale
Standard Deviation 2.17
|
0.69 Unit on a scale
Standard Deviation 3.22
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C24D1
|
-0.45 Unit on a scale
Standard Deviation 3.41
|
-0.33 Unit on a scale
Standard Deviation 1.72
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C25D1
|
-0.86 Unit on a scale
Standard Deviation 2.17
|
0.17 Unit on a scale
Standard Deviation 3.21
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C26D1
|
-0.58 Unit on a scale
Standard Deviation 2.53
|
0.22 Unit on a scale
Standard Deviation 1.86
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C28D1
|
0.05 Unit on a scale
Standard Deviation 2.89
|
0.18 Unit on a scale
Standard Deviation 1.33
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C29D1
|
-0.14 Unit on a scale
Standard Deviation 2.25
|
-0.17 Unit on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C35D1
|
-0.69 Unit on a scale
Standard Deviation 2.84
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C36D1
|
-1.42 Unit on a scale
Standard Deviation 1.56
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C37D1
|
0.18 Unit on a scale
Standard Deviation 3.06
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C38D1
|
0.00 Unit on a scale
Standard Deviation 3.53
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C39D1
|
-0.89 Unit on a scale
Standard Deviation 1.27
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
30 day follow up
|
0.74 Unit on a scale
Standard Deviation 3.34
|
0.56 Unit on a scale
Standard Deviation 2.63
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C2D1
|
-0.60 Unit on a scale
Standard Deviation 2.61
|
-0.63 Unit on a scale
Standard Deviation 2.59
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C3D1
|
-0.74 Unit on a scale
Standard Deviation 2.30
|
-0.82 Unit on a scale
Standard Deviation 2.33
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C4D1
|
-0.63 Unit on a scale
Standard Deviation 2.58
|
-0.91 Unit on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow upPopulation: FAS with available data was analyzed.
EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=243 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
n=243 Participants
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility Baseline
|
1.33 Unit on a scale
Standard Deviation 0.67
|
1.33 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C3D1
|
-0.01 Unit on a scale
Standard Deviation 0.61
|
0.05 Unit on a scale
Standard Deviation 0.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C7D1
|
0.02 Unit on a scale
Standard Deviation 0.72
|
0.02 Unit on a scale
Standard Deviation 0.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C8D1
|
0.20 Unit on a scale
Standard Deviation 0.81
|
0.05 Unit on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C12D1
|
0.08 Unit on a scale
Standard Deviation 0.65
|
0.02 Unit on a scale
Standard Deviation 0.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C13D1
|
0.08 Unit on a scale
Standard Deviation 0.74
|
0.10 Unit on a scale
Standard Deviation 0.85
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C17D1
|
0.00 Unit on a scale
Standard Deviation 0.72
|
0.08 Unit on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C19D1
|
0.03 Unit on a scale
Standard Deviation 0.53
|
0.00 Unit on a scale
Standard Deviation 0.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C21D1
|
0.03 Unit on a scale
Standard Deviation 0.51
|
-0.14 Unit on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C23D1
|
0.00 Unit on a scale
Standard Deviation 0.58
|
-0.12 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C27D1
|
0.08 Unit on a scale
Standard Deviation 0.76
|
-0.09 Unit on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C29D1
|
0.05 Unit on a scale
Standard Deviation 0.65
|
-0.08 Unit on a scale
Standard Deviation 0.51
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C31D1
|
0.00 Unit on a scale
Standard Deviation 0.56
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care Baseline
|
1.12 Unit on a scale
Standard Deviation 0.39
|
1.18 Unit on a scale
Standard Deviation 0.56
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C3D1
|
0.02 Unit on a scale
Standard Deviation 0.44
|
0.03 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C4D1
|
0.05 Unit on a scale
Standard Deviation 0.46
|
0.02 Unit on a scale
Standard Deviation 0.64
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C7D1
|
0.07 Unit on a scale
Standard Deviation 0.60
|
0.02 Unit on a scale
Standard Deviation 0.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C8D1
|
0.10 Unit on a scale
Standard Deviation 0.64
|
0.05 Unit on a scale
Standard Deviation 0.62
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C9D1
|
0.15 Unit on a scale
Standard Deviation 0.79
|
0.10 Unit on a scale
Standard Deviation 0.58
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C10D1
|
0.11 Unit on a scale
Standard Deviation 0.66
|
0.10 Unit on a scale
Standard Deviation 0.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C15D1
|
0.00 Unit on a scale
Standard Deviation 0.49
|
0.05 Unit on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C17D1
|
0.02 Unit on a scale
Standard Deviation 0.64
|
0.04 Unit on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C21D1
|
0.03 Unit on a scale
Standard Deviation 0.38
|
-0.10 Unit on a scale
Standard Deviation 0.44
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C22D1
|
0.00 Unit on a scale
Standard Deviation 0.37
|
0.00 Unit on a scale
Standard Deviation 0.59
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C23D1
|
0.06 Unit on a scale
Standard Deviation 0.36
|
-0.12 Unit on a scale
Standard Deviation 0.49
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C24D1
|
0.07 Unit on a scale
Standard Deviation 0.26
|
-0.08 Unit on a scale
Standard Deviation 0.64
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression Baseline
|
1.65 Unit on a scale
Standard Deviation 0.82
|
1.64 Unit on a scale
Standard Deviation 0.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C17D1
|
0.05 Unit on a scale
Standard Deviation 0.72
|
0.15 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C28D1
|
0.14 Unit on a scale
Standard Deviation 1.06
|
0.09 Unit on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C2D1
|
0.02 Unit on a scale
Standard Deviation 0.60
|
0.06 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C4D1
|
-0.01 Unit on a scale
Standard Deviation 0.62
|
0.02 Unit on a scale
Standard Deviation 0.76
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C5D1
|
0.05 Unit on a scale
Standard Deviation 0.65
|
0.00 Unit on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C6D1
|
0.04 Unit on a scale
Standard Deviation 0.77
|
0.03 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C9D1
|
0.18 Unit on a scale
Standard Deviation 0.78
|
0.06 Unit on a scale
Standard Deviation 0.75
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C10D1
|
0.08 Unit on a scale
Standard Deviation 0.74
|
0.13 Unit on a scale
Standard Deviation 0.74
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C11D1
|
0.12 Unit on a scale
Standard Deviation 0.68
|
0.15 Unit on a scale
Standard Deviation 0.87
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C14D1
|
-0.05 Unit on a scale
Standard Deviation 0.64
|
0.11 Unit on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C15D1
|
-0.04 Unit on a scale
Standard Deviation 0.69
|
0.03 Unit on a scale
Standard Deviation 0.55
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C16D1
|
0.02 Unit on a scale
Standard Deviation 0.64
|
0.06 Unit on a scale
Standard Deviation 0.56
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C18D1
|
0.07 Unit on a scale
Standard Deviation 0.52
|
0.09 Unit on a scale
Standard Deviation 0.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C20D1
|
0.10 Unit on a scale
Standard Deviation 0.55
|
0.10 Unit on a scale
Standard Deviation 0.55
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C22D1
|
0.03 Unit on a scale
Standard Deviation 0.55
|
-0.11 Unit on a scale
Standard Deviation 0.58
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C24D1
|
0.07 Unit on a scale
Standard Deviation 0.53
|
-0.15 Unit on a scale
Standard Deviation 0.69
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C25D1
|
0.21 Unit on a scale
Standard Deviation 0.63
|
-0.08 Unit on a scale
Standard Deviation 0.76
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C26D1
|
0.15 Unit on a scale
Standard Deviation 0.54
|
0.10 Unit on a scale
Standard Deviation 0.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C28D1
|
0.24 Unit on a scale
Standard Deviation 0.89
|
0.09 Unit on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C30D1
|
0.10 Unit on a scale
Standard Deviation 0.64
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C32D1
|
0.06 Unit on a scale
Standard Deviation 0.54
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C33D1
|
0.00 Unit on a scale
Standard Deviation 0.76
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C34D1
|
-0.08 Unit on a scale
Standard Deviation 0.79
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C35D1
|
-0.08 Unit on a scale
Standard Deviation 0.76
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C36D1
|
-0.08 Unit on a scale
Standard Deviation 0.51
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C37D1
|
0.00 Unit on a scale
Standard Deviation 0.63
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C38D1
|
0.00 Unit on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C39D1
|
0.22 Unit on a scale
Standard Deviation 0.83
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility 30 day follow up
|
0.47 Unit on a scale
Standard Deviation 0.96
|
0.36 Unit on a scale
Standard Deviation 0.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility 90 day follow up
|
0.32 Unit on a scale
Standard Deviation 0.76
|
0.43 Unit on a scale
Standard Deviation 0.90
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C2D1
|
0.05 Unit on a scale
Standard Deviation 0.48
|
0.07 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C5D1
|
0.05 Unit on a scale
Standard Deviation 0.55
|
0.07 Unit on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C6D1
|
0.05 Unit on a scale
Standard Deviation 0.51
|
0.09 Unit on a scale
Standard Deviation 0.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C11D1
|
0.09 Unit on a scale
Standard Deviation 0.64
|
0.06 Unit on a scale
Standard Deviation 0.69
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C12D1
|
0.09 Unit on a scale
Standard Deviation 0.64
|
0.10 Unit on a scale
Standard Deviation 0.55
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C13D1
|
0.05 Unit on a scale
Standard Deviation 0.62
|
0.12 Unit on a scale
Standard Deviation 0.56
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C14D1
|
0.04 Unit on a scale
Standard Deviation 0.50
|
0.11 Unit on a scale
Standard Deviation 0.61
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C16D1
|
0.00 Unit on a scale
Standard Deviation 0.62
|
0.09 Unit on a scale
Standard Deviation 0.59
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C18D1
|
0.10 Unit on a scale
Standard Deviation 0.49
|
-0.05 Unit on a scale
Standard Deviation 0.49
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C19D1
|
0.00 Unit on a scale
Standard Deviation 0.32
|
-0.10 Unit on a scale
Standard Deviation 0.44
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C20D1
|
0.00 Unit on a scale
Standard Deviation 0.32
|
0.05 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C25D1
|
0.11 Unit on a scale
Standard Deviation 0.31
|
-0.08 Unit on a scale
Standard Deviation 0.64
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C26D1
|
0.12 Unit on a scale
Standard Deviation 0.33
|
-0.20 Unit on a scale
Standard Deviation 0.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C27D1
|
0.08 Unit on a scale
Standard Deviation 0.28
|
-0.18 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C28D1
|
0.10 Unit on a scale
Standard Deviation 0.44
|
-0.18 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C29D1
|
0.14 Unit on a scale
Standard Deviation 0.47
|
-0.17 Unit on a scale
Standard Deviation 0.58
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C30D1
|
0.10 Unit on a scale
Standard Deviation 0.45
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C31D1
|
0.10 Unit on a scale
Standard Deviation 0.45
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C32D1
|
0.06 Unit on a scale
Standard Deviation 0.54
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C33D1
|
0.13 Unit on a scale
Standard Deviation 0.35
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C34D1
|
0.08 Unit on a scale
Standard Deviation 0.29
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C35D1
|
0.08 Unit on a scale
Standard Deviation 0.28
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C36D1
|
0.08 Unit on a scale
Standard Deviation 0.29
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C37D1
|
0.27 Unit on a scale
Standard Deviation 0.47
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C38D1
|
0.20 Unit on a scale
Standard Deviation 0.42
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care C39D1
|
0.22 Unit on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care 30 day follow up
|
0.34 Unit on a scale
Standard Deviation 0.89
|
0.38 Unit on a scale
Standard Deviation 0.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care 90 day follow up
|
0.30 Unit on a scale
Standard Deviation 0.82
|
0.25 Unit on a scale
Standard Deviation 0.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities Baseline
|
1.40 Unit on a scale
Standard Deviation 0.72
|
1.49 Unit on a scale
Standard Deviation 0.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C2D1
|
0.08 Unit on a scale
Standard Deviation 0.81
|
0.06 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C3D1
|
0.02 Unit on a scale
Standard Deviation 0.66
|
0.04 Unit on a scale
Standard Deviation 0.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C4D1
|
0.01 Unit on a scale
Standard Deviation 0.76
|
-0.01 Unit on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C5D1
|
0.10 Unit on a scale
Standard Deviation 0.86
|
0.01 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C6D1
|
0.05 Unit on a scale
Standard Deviation 0.71
|
-0.03 Unit on a scale
Standard Deviation 0.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C7D1
|
0.05 Unit on a scale
Standard Deviation 0.81
|
-0.01 Unit on a scale
Standard Deviation 0.83
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C8D1
|
0.19 Unit on a scale
Standard Deviation 0.76
|
0.07 Unit on a scale
Standard Deviation 0.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C9D1
|
0.19 Unit on a scale
Standard Deviation 0.78
|
-0.03 Unit on a scale
Standard Deviation 0.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C10D1
|
0.06 Unit on a scale
Standard Deviation 0.75
|
0.03 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C11D1
|
0.11 Unit on a scale
Standard Deviation 0.72
|
-0.04 Unit on a scale
Standard Deviation 0.74
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C12D1
|
0.04 Unit on a scale
Standard Deviation 0.71
|
-0.03 Unit on a scale
Standard Deviation 0.94
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C13D1
|
0.02 Unit on a scale
Standard Deviation 0.79
|
0.02 Unit on a scale
Standard Deviation 0.80
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C14D1
|
0.02 Unit on a scale
Standard Deviation 0.73
|
0.00 Unit on a scale
Standard Deviation 0.64
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C15D1
|
0.10 Unit on a scale
Standard Deviation 0.67
|
-0.14 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C16D1
|
0.04 Unit on a scale
Standard Deviation 0.65
|
-0.06 Unit on a scale
Standard Deviation 0.56
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C17D1
|
0.00 Unit on a scale
Standard Deviation 0.65
|
-0.08 Unit on a scale
Standard Deviation 0.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C18D1
|
0.15 Unit on a scale
Standard Deviation 0.57
|
-0.14 Unit on a scale
Standard Deviation 0.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C19D1
|
0.13 Unit on a scale
Standard Deviation 0.61
|
-0.38 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C20D1
|
0.13 Unit on a scale
Standard Deviation 0.57
|
-0.25 Unit on a scale
Standard Deviation 0.79
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C21D1
|
0.17 Unit on a scale
Standard Deviation 0.51
|
-0.24 Unit on a scale
Standard Deviation 0.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C22D1
|
0.06 Unit on a scale
Standard Deviation 0.44
|
-0.22 Unit on a scale
Standard Deviation 0.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C23D1
|
0.06 Unit on a scale
Standard Deviation 0.51
|
-0.24 Unit on a scale
Standard Deviation 0.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C24D1
|
0.17 Unit on a scale
Standard Deviation 0.47
|
-0.38 Unit on a scale
Standard Deviation 0.87
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C25D1
|
0.25 Unit on a scale
Standard Deviation 0.52
|
-0.15 Unit on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C26D1
|
0.12 Unit on a scale
Standard Deviation 0.43
|
-0.30 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C27D1
|
0.12 Unit on a scale
Standard Deviation 0.44
|
-0.36 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C28D1
|
0.29 Unit on a scale
Standard Deviation 0.56
|
-0.18 Unit on a scale
Standard Deviation 0.75
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C29D1
|
0.14 Unit on a scale
Standard Deviation 0.56
|
-0.33 Unit on a scale
Standard Deviation 0.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C30D1
|
0.15 Unit on a scale
Standard Deviation 0.59
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C31D1
|
0.05 Unit on a scale
Standard Deviation 0.51
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C32D1
|
0.11 Unit on a scale
Standard Deviation 0.76
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C33D1
|
-0.07 Unit on a scale
Standard Deviation 0.59
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C34D1
|
-0.08 Unit on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C35D1
|
0.08 Unit on a scale
Standard Deviation 0.86
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C36D1
|
-0.08 Unit on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C37D1
|
0.00 Unit on a scale
Standard Deviation 0.77
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C38D1
|
0.10 Unit on a scale
Standard Deviation 0.57
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C39D1
|
0.22 Unit on a scale
Standard Deviation 0.44
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities 30 day follow up
|
0.57 Unit on a scale
Standard Deviation 1.16
|
0.40 Unit on a scale
Standard Deviation 0.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities 90 day follow up
|
0.41 Unit on a scale
Standard Deviation 0.87
|
0.29 Unit on a scale
Standard Deviation 0.94
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort Baseline
|
1.86 Unit on a scale
Standard Deviation 0.86
|
1.84 Unit on a scale
Standard Deviation 0.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C2D1
|
-0.17 Unit on a scale
Standard Deviation 0.86
|
-0.13 Unit on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C3D1
|
-0.21 Unit on a scale
Standard Deviation 0.76
|
-0.16 Unit on a scale
Standard Deviation 0.75
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C4D1
|
-0.26 Unit on a scale
Standard Deviation 0.87
|
-0.29 Unit on a scale
Standard Deviation 0.91
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C5D1
|
-0.23 Unit on a scale
Standard Deviation 0.87
|
-0.26 Unit on a scale
Standard Deviation 0.90
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C6D1
|
-0.18 Unit on a scale
Standard Deviation 0.82
|
-0.22 Unit on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C7D1
|
-0.26 Unit on a scale
Standard Deviation 0.87
|
-0.20 Unit on a scale
Standard Deviation 0.83
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C8D1
|
-0.23 Unit on a scale
Standard Deviation 0.86
|
-0.19 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C9D1
|
-0.14 Unit on a scale
Standard Deviation 0.75
|
-0.18 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C10D1
|
-0.19 Unit on a scale
Standard Deviation 0.87
|
-0.18 Unit on a scale
Standard Deviation 0.91
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C11D1
|
-0.28 Unit on a scale
Standard Deviation 0.93
|
-0.11 Unit on a scale
Standard Deviation 0.96
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C12D1
|
-0.19 Unit on a scale
Standard Deviation 0.83
|
-0.09 Unit on a scale
Standard Deviation 0.90
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C13D1
|
-0.25 Unit on a scale
Standard Deviation 0.84
|
0.04 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C14D1
|
-0.36 Unit on a scale
Standard Deviation 0.82
|
-0.02 Unit on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C15D1
|
-0.27 Unit on a scale
Standard Deviation 0.80
|
0.00 Unit on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C16D1
|
-0.35 Unit on a scale
Standard Deviation 0.86
|
-0.03 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C17D1
|
-0.26 Unit on a scale
Standard Deviation 0.73
|
0.08 Unit on a scale
Standard Deviation 0.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C18D1
|
-0.15 Unit on a scale
Standard Deviation 0.69
|
0.00 Unit on a scale
Standard Deviation 0.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C19D1
|
-0.15 Unit on a scale
Standard Deviation 0.80
|
-0.05 Unit on a scale
Standard Deviation 0.50
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C20D1
|
-0.05 Unit on a scale
Standard Deviation 0.72
|
-0.15 Unit on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C21D1
|
-0.22 Unit on a scale
Standard Deviation 0.72
|
-0.05 Unit on a scale
Standard Deviation 0.80
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C22D1
|
-0.16 Unit on a scale
Standard Deviation 0.78
|
-0.28 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C23D1
|
-0.16 Unit on a scale
Standard Deviation 0.73
|
-0.18 Unit on a scale
Standard Deviation 1.01
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C24D1
|
-0.14 Unit on a scale
Standard Deviation 0.79
|
0.00 Unit on a scale
Standard Deviation 1.08
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C25D1
|
-0.14 Unit on a scale
Standard Deviation 0.85
|
0.00 Unit on a scale
Standard Deviation 1.08
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C26D1
|
-0.19 Unit on a scale
Standard Deviation 0.75
|
0.20 Unit on a scale
Standard Deviation 0.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C27D1
|
-0.16 Unit on a scale
Standard Deviation 0.80
|
0.00 Unit on a scale
Standard Deviation 0.45
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C28D1
|
-0.29 Unit on a scale
Standard Deviation 0.85
|
0.18 Unit on a scale
Standard Deviation 0.75
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C29D1
|
-0.14 Unit on a scale
Standard Deviation 0.77
|
-0.08 Unit on a scale
Standard Deviation 0.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C30D1
|
-0.30 Unit on a scale
Standard Deviation 0.73
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C31D1
|
-0.40 Unit on a scale
Standard Deviation 0.68
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C32D1
|
-0.33 Unit on a scale
Standard Deviation 0.84
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C33D1
|
-0.40 Unit on a scale
Standard Deviation 0.74
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C34D1
|
-0.33 Unit on a scale
Standard Deviation 0.78
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C35D1
|
-0.23 Unit on a scale
Standard Deviation 0.60
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C36D1
|
-0.42 Unit on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C37D1
|
-0.27 Unit on a scale
Standard Deviation 0.65
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C38D1
|
-0.30 Unit on a scale
Standard Deviation 0.95
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C39D1
|
-0.44 Unit on a scale
Standard Deviation 0.53
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort 30 day follow up
|
0.29 Unit on a scale
Standard Deviation 1.14
|
0.32 Unit on a scale
Standard Deviation 0.95
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort 90 day follow up
|
-0.03 Unit on a scale
Standard Deviation 0.92
|
0.10 Unit on a scale
Standard Deviation 0.94
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C2D1
|
-0.01 Unit on a scale
Standard Deviation 0.83
|
-0.11 Unit on a scale
Standard Deviation 0.79
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C3D1
|
-0.05 Unit on a scale
Standard Deviation 0.68
|
-0.01 Unit on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C4D1
|
-0.04 Unit on a scale
Standard Deviation 0.74
|
-0.08 Unit on a scale
Standard Deviation 0.89
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C5D1
|
-0.08 Unit on a scale
Standard Deviation 0.77
|
-0.07 Unit on a scale
Standard Deviation 0.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C6D1
|
-0.07 Unit on a scale
Standard Deviation 0.75
|
0.00 Unit on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C7D1
|
-0.04 Unit on a scale
Standard Deviation 0.80
|
-0.04 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C8D1
|
-0.02 Unit on a scale
Standard Deviation 0.77
|
0.06 Unit on a scale
Standard Deviation 0.83
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C9D1
|
-0.05 Unit on a scale
Standard Deviation 0.81
|
0.03 Unit on a scale
Standard Deviation 0.83
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C10D1
|
-0.13 Unit on a scale
Standard Deviation 0.84
|
0.13 Unit on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C11D1
|
-0.11 Unit on a scale
Standard Deviation 0.81
|
0.21 Unit on a scale
Standard Deviation 0.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C12D1
|
-0.11 Unit on a scale
Standard Deviation 0.83
|
0.17 Unit on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C13D1
|
-0.12 Unit on a scale
Standard Deviation 0.74
|
0.20 Unit on a scale
Standard Deviation 0.87
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C14D1
|
-0.07 Unit on a scale
Standard Deviation 0.78
|
0.22 Unit on a scale
Standard Deviation 0.85
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C15D1
|
-0.02 Unit on a scale
Standard Deviation 0.62
|
0.19 Unit on a scale
Standard Deviation 0.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C16D1
|
0.00 Unit on a scale
Standard Deviation 0.71
|
0.06 Unit on a scale
Standard Deviation 0.62
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C18D1
|
0.12 Unit on a scale
Standard Deviation 0.78
|
0.00 Unit on a scale
Standard Deviation 0.69
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C19D1
|
-0.10 Unit on a scale
Standard Deviation 0.78
|
-0.05 Unit on a scale
Standard Deviation 0.38
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C20D1
|
-0.03 Unit on a scale
Standard Deviation 0.71
|
0.05 Unit on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C21D1
|
-0.03 Unit on a scale
Standard Deviation 0.84
|
-0.05 Unit on a scale
Standard Deviation 0.59
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C22D1
|
-0.10 Unit on a scale
Standard Deviation 0.54
|
0.17 Unit on a scale
Standard Deviation 0.71
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C23D1
|
-0.03 Unit on a scale
Standard Deviation 0.71
|
0.18 Unit on a scale
Standard Deviation 0.95
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C24D1
|
-0.10 Unit on a scale
Standard Deviation 0.62
|
0.00 Unit on a scale
Standard Deviation 0.58
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C25D1
|
0.11 Unit on a scale
Standard Deviation 1.03
|
0.15 Unit on a scale
Standard Deviation 0.55
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C26D1
|
0.00 Unit on a scale
Standard Deviation 0.80
|
0.20 Unit on a scale
Standard Deviation 0.42
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C27D1
|
0.00 Unit on a scale
Standard Deviation 1.04
|
0.09 Unit on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C29D1
|
-0.09 Unit on a scale
Standard Deviation 0.97
|
0.25 Unit on a scale
Standard Deviation 0.45
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C30D1
|
-0.10 Unit on a scale
Standard Deviation 0.85
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C31D1
|
0.00 Unit on a scale
Standard Deviation 1.08
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C32D1
|
-0.17 Unit on a scale
Standard Deviation 0.86
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C33D1
|
-0.07 Unit on a scale
Standard Deviation 0.88
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C34D1
|
-0.42 Unit on a scale
Standard Deviation 0.51
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C35D1
|
-0.23 Unit on a scale
Standard Deviation 0.60
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C36D1
|
-0.25 Unit on a scale
Standard Deviation 0.45
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C37D1
|
-0.45 Unit on a scale
Standard Deviation 0.52
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C38D1
|
-0.60 Unit on a scale
Standard Deviation 0.84
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C39D1
|
-0.11 Unit on a scale
Standard Deviation 0.60
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression 30 day follow up
|
0.41 Unit on a scale
Standard Deviation 1.27
|
0.45 Unit on a scale
Standard Deviation 1.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression 90 day follow up
|
0.10 Unit on a scale
Standard Deviation 0.76
|
0.24 Unit on a scale
Standard Deviation 1.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale Baseline
|
71.50 Unit on a scale
Standard Deviation 19.60
|
72.65 Unit on a scale
Standard Deviation 18.73
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C2D1
|
3.01 Unit on a scale
Standard Deviation 15.83
|
1.67 Unit on a scale
Standard Deviation 13.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C3D1
|
2.17 Unit on a scale
Standard Deviation 15.19
|
2.07 Unit on a scale
Standard Deviation 14.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C4D1
|
3.89 Unit on a scale
Standard Deviation 16.60
|
3.27 Unit on a scale
Standard Deviation 18.37
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C5D1
|
1.50 Unit on a scale
Standard Deviation 17.20
|
3.74 Unit on a scale
Standard Deviation 17.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C6D1
|
1.18 Unit on a scale
Standard Deviation 17.61
|
1.95 Unit on a scale
Standard Deviation 15.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C7D1
|
3.21 Unit on a scale
Standard Deviation 15.60
|
2.73 Unit on a scale
Standard Deviation 19.74
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C8D1
|
3.22 Unit on a scale
Standard Deviation 19.72
|
1.73 Unit on a scale
Standard Deviation 17.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C9D1
|
0.96 Unit on a scale
Standard Deviation 17.32
|
2.49 Unit on a scale
Standard Deviation 18.01
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C10D1
|
2.88 Unit on a scale
Standard Deviation 20.07
|
1.48 Unit on a scale
Standard Deviation 17.73
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C11D1
|
-1.12 Unit on a scale
Standard Deviation 18.13
|
1.50 Unit on a scale
Standard Deviation 18.57
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C12D1
|
2.89 Unit on a scale
Standard Deviation 21.70
|
1.36 Unit on a scale
Standard Deviation 24.31
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C13D1
|
4.30 Unit on a scale
Standard Deviation 17.81
|
0.88 Unit on a scale
Standard Deviation 20.52
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C14D1
|
5.68 Unit on a scale
Standard Deviation 25.25
|
2.20 Unit on a scale
Standard Deviation 23.17
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C15D1
|
4.61 Unit on a scale
Standard Deviation 23.63
|
-1.84 Unit on a scale
Standard Deviation 19.58
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C16D1
|
2.40 Unit on a scale
Standard Deviation 18.26
|
3.44 Unit on a scale
Standard Deviation 25.37
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C17D1
|
6.07 Unit on a scale
Standard Deviation 24.08
|
2.35 Unit on a scale
Standard Deviation 13.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C18D1
|
8.49 Unit on a scale
Standard Deviation 24.62
|
4.59 Unit on a scale
Standard Deviation 12.68
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C19D1
|
5.08 Unit on a scale
Standard Deviation 21.11
|
5.95 Unit on a scale
Standard Deviation 10.28
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C20D1
|
2.97 Unit on a scale
Standard Deviation 25.52
|
4.15 Unit on a scale
Standard Deviation 14.14
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C21D1
|
0.69 Unit on a scale
Standard Deviation 19.39
|
6.29 Unit on a scale
Standard Deviation 10.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C22D1
|
3.55 Unit on a scale
Standard Deviation 15.24
|
3.28 Unit on a scale
Standard Deviation 13.40
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C23D1
|
3.55 Unit on a scale
Standard Deviation 14.93
|
4.12 Unit on a scale
Standard Deviation 16.03
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C24D1
|
5.17 Unit on a scale
Standard Deviation 16.19
|
6.85 Unit on a scale
Standard Deviation 14.15
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C25D1
|
1.43 Unit on a scale
Standard Deviation 20.29
|
7.15 Unit on a scale
Standard Deviation 12.08
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C26D1
|
4.15 Unit on a scale
Standard Deviation 16.83
|
1.20 Unit on a scale
Standard Deviation 12.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C27D1
|
0.20 Unit on a scale
Standard Deviation 20.58
|
4.73 Unit on a scale
Standard Deviation 4.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C28D1
|
2.90 Unit on a scale
Standard Deviation 18.30
|
2.36 Unit on a scale
Standard Deviation 6.02
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C29D1
|
3.73 Unit on a scale
Standard Deviation 15.74
|
3.58 Unit on a scale
Standard Deviation 5.95
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C30D1
|
0.75 Unit on a scale
Standard Deviation 15.87
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C31D1
|
1.60 Unit on a scale
Standard Deviation 16.83
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C32D1
|
2.00 Unit on a scale
Standard Deviation 15.78
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C33D1
|
6.80 Unit on a scale
Standard Deviation 17.07
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C34D1
|
8.33 Unit on a scale
Standard Deviation 17.91
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C35D1
|
5.77 Unit on a scale
Standard Deviation 16.63
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C36D1
|
4.17 Unit on a scale
Standard Deviation 17.20
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C37D1
|
10.73 Unit on a scale
Standard Deviation 14.55
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C38D1
|
7.10 Unit on a scale
Standard Deviation 17.70
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C39D1
|
10.22 Unit on a scale
Standard Deviation 11.42
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale 30 day follow up
|
-7.79 Unit on a scale
Standard Deviation 23.72
|
-8.63 Unit on a scale
Standard Deviation 20.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale 90 day follow up
|
-5.24 Unit on a scale
Standard Deviation 19.73
|
-4.34 Unit on a scale
Standard Deviation 19.79
|
SECONDARY outcome
Timeframe: Predose on C2D1,C5D1,C9D1,C13D1,C17D1Population: Pharmakokinetic analysis set (PKAS) consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed.
Ctrough was defined as the predose concentration at the end of dosing interval.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=217 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C2D1
|
38.6 micrograms/mililiter (ug/mL)
Standard Deviation 31.3
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C5D1
|
74.1 micrograms/mililiter (ug/mL)
Standard Deviation 51.6
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C9D1
|
99.6 micrograms/mililiter (ug/mL)
Standard Deviation 58.2
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C13D1
|
119.0 micrograms/mililiter (ug/mL)
Standard Deviation 55.6
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C17D1
|
147.0 micrograms/mililiter (ug/mL)
Standard Deviation 70.5
|
—
|
SECONDARY outcome
Timeframe: Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow upPopulation: Participants who were Randomized to Zolbetuximab + CAPOX Arm with at least One Valid Result for ADA
Immunogenicity will be measured by the number of participants that are ADA positive.
Outcome measures
| Measure |
CAPOX+ Zolbetuximab
n=249 Participants
Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
|
CAPOX+ Placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C1D1
|
4 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C2D2
|
8 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C5D1
|
2 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C9D1
|
1 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C13D1
|
0 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
C17D1
|
0 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
30 Day follow up
|
5 Participants
|
—
|
|
Number of Anti-drug Antibody (ADA) Positive Participants
90 Day follow up
|
1 Participants
|
—
|
Adverse Events
Zolbetuximab
Serious events: 123 serious events
Other events: 249 other events
Deaths: 180 deaths
Capecitabine
Serious events: 249 serious events
Other events: 481 other events
Deaths: 387 deaths
Oxaliplatin
Serious events: 249 serious events
Other events: 481 other events
Deaths: 387 deaths
Placebo
Serious events: 126 serious events
Other events: 232 other events
Deaths: 207 deaths
Serious adverse events
| Measure |
Zolbetuximab
n=254 participants at risk
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
Capecitabine
n=503 participants at risk
Participants received capecitabine orally at 1000 mg/m\^2 (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
Oxaliplatin
n=503 participants at risk
Participants received an IV infusion of oxaliplatin 130 mg/m\^2 on day 1 of each cycle over 2 hours for a maximum of 8 treatments. Each cycle was approximately 21 days.
|
Placebo
n=249 participants at risk
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|---|---|
|
Infections and infestations
Bacterial infection
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Biliary tract infection
|
0.39%
1/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Psychiatric disorders
Delirium
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
COVID-19
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Device related infection
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Flushing
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Hypotension
|
1.6%
4/254 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Infection
|
0.79%
2/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Klebsiella sepsis
|
0.39%
1/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Venous thrombosis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Peritonitis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
5/254 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.2%
11/503 • Number of events 15 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.2%
11/503 • Number of events 15 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Pneumonia
|
2.4%
6/254 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
12/503 • Number of events 14 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
12/503 • Number of events 14 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Bone marrow infiltration
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.39%
1/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
4/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
10/503 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
10/503 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.8%
7/249 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
3/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
5/249 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Colitis
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
7/254 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.4%
17/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.4%
17/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.0%
10/249 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
4/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
4/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Haematemesis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.39%
1/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
11/254 • Number of events 12 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.4%
17/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.4%
17/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.6%
4/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Oesophageal-pulmonary fistula
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.8%
7/254 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.2%
11/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.2%
11/503 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
4/249 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
15/254 • Number of events 21 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
26/503 • Number of events 35 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
26/503 • Number of events 35 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.4%
11/249 • Number of events 14 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Asthenia
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Death
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Fatigue
|
1.2%
3/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
6/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Gait inability
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Gravitational oedema
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Incarcerated hernia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Infusion site extravasation
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Malaise
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Mucosal inflammation
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Oedema peripheral
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Performance status decreased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Peripheral swelling
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Pyrexia
|
2.0%
5/254 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Sudden death
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Deficiency of bile secretion
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Hepatobiliary disorders
Liver injury
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Immune system disorders
Anaphylactic reaction
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Abdominal infection
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Abdominal sepsis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Bacteraemia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Pyelonephritis acute
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Sepsis
|
0.39%
1/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Septic shock
|
0.79%
2/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
Wound infection
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
1/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 6 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Aspartate aminotransferase increased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Blood bilirubin increased
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
International normalised ratio increased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Neutrophil count decreased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Platelet count decreased
|
3.1%
8/254 • Number of events 28 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.8%
14/503 • Number of events 48 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.8%
14/503 • Number of events 48 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 20 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Weight decreased
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
White blood cell count decreased
|
0.39%
1/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.9%
10/254 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.6%
13/503 • Number of events 13 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.6%
13/503 • Number of events 13 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
4/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.39%
1/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
6/254 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
12/503 • Number of events 14 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
12/503 • Number of events 14 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.39%
1/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.9%
10/254 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.6%
23/503 • Number of events 23 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.6%
23/503 • Number of events 23 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
13/249 • Number of events 13 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.79%
2/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Paraesthesia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Syncope
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Product Issues
Device occlusion
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Psychiatric disorders
Confusional state
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
4/254 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.99%
5/503 • Number of events 5 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Choluria
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Renal failure
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Renal impairment
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.2%
3/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
2/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.4%
7/503 • Number of events 12 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.4%
7/503 • Number of events 12 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
5/249 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
1/254 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
1.6%
8/503 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.8%
7/249 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.79%
2/254 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
10/503 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.0%
10/503 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.2%
8/249 • Number of events 9 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
2/503 • Number of events 2 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.60%
3/503 • Number of events 4 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.80%
2/249 • Number of events 3 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Embolism
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Embolism venous
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/254 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.40%
1/249 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.39%
1/254 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.20%
1/503 • Number of events 1 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
0.00%
0/249 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
Other adverse events
| Measure |
Zolbetuximab
n=254 participants at risk
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
Capecitabine
n=503 participants at risk
Participants received capecitabine orally at 1000 mg/m\^2 (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
Oxaliplatin
n=503 participants at risk
Participants received an IV infusion of oxaliplatin 130 mg/m\^2 on day 1 of each cycle over 2 hours for a maximum of 8 treatments. Each cycle was approximately 21 days.
|
Placebo
n=249 participants at risk
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.6%
27/254 • Number of events 68 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
11.1%
56/503 • Number of events 133 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
11.1%
56/503 • Number of events 133 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
11.6%
29/249 • Number of events 65 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
15/254 • Number of events 21 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.8%
29/503 • Number of events 36 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.8%
29/503 • Number of events 36 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.6%
14/249 • Number of events 15 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.7%
40/254 • Number of events 54 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.1%
91/503 • Number of events 120 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.1%
91/503 • Number of events 120 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
20.5%
51/249 • Number of events 66 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
24/254 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
7.4%
37/503 • Number of events 57 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
7.4%
37/503 • Number of events 57 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
13/249 • Number of events 20 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Constipation
|
15.7%
40/254 • Number of events 53 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.5%
93/503 • Number of events 121 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.5%
93/503 • Number of events 121 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
21.3%
53/249 • Number of events 68 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.1%
79/254 • Number of events 134 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
32.2%
162/503 • Number of events 322 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
32.2%
162/503 • Number of events 322 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
33.3%
83/249 • Number of events 188 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Nausea
|
68.5%
174/254 • Number of events 503 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
59.0%
297/503 • Number of events 786 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
59.0%
297/503 • Number of events 786 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
49.4%
123/249 • Number of events 283 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Vomiting
|
64.6%
164/254 • Number of events 463 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
46.9%
236/503 • Number of events 616 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
46.9%
236/503 • Number of events 616 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
28.9%
72/249 • Number of events 153 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Asthenia
|
13.4%
34/254 • Number of events 67 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.9%
65/503 • Number of events 122 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.9%
65/503 • Number of events 122 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.4%
31/249 • Number of events 55 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Fatigue
|
13.4%
34/254 • Number of events 64 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
14.7%
74/503 • Number of events 157 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
14.7%
74/503 • Number of events 157 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
16.1%
40/249 • Number of events 93 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Malaise
|
11.8%
30/254 • Number of events 107 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
10.3%
52/503 • Number of events 178 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
10.3%
52/503 • Number of events 178 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
8.8%
22/249 • Number of events 71 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Oedema peripheral
|
10.2%
26/254 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.4%
32/503 • Number of events 45 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.4%
32/503 • Number of events 45 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.4%
6/249 • Number of events 8 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
General disorders
Pyrexia
|
12.6%
32/254 • Number of events 46 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
10.5%
53/503 • Number of events 77 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
10.5%
53/503 • Number of events 77 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
8.4%
21/249 • Number of events 31 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Alanine aminotransferase increased
|
18.5%
47/254 • Number of events 66 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
19.7%
99/503 • Number of events 165 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
19.7%
99/503 • Number of events 165 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
20.9%
52/249 • Number of events 99 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Aspartate aminotransferase increased
|
24.4%
62/254 • Number of events 106 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
27.0%
136/503 • Number of events 246 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
27.0%
136/503 • Number of events 246 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
29.7%
74/249 • Number of events 140 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.5%
14/254 • Number of events 24 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.8%
34/503 • Number of events 54 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.8%
34/503 • Number of events 54 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
8.0%
20/249 • Number of events 30 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Blood bilirubin increased
|
9.4%
24/254 • Number of events 69 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
9.3%
47/503 • Number of events 118 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
9.3%
47/503 • Number of events 118 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
9.2%
23/249 • Number of events 49 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Neutrophil count decreased
|
28.0%
71/254 • Number of events 374 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
25.6%
129/503 • Number of events 635 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
25.6%
129/503 • Number of events 635 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
23.3%
58/249 • Number of events 261 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Platelet count decreased
|
23.6%
60/254 • Number of events 185 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
24.1%
121/503 • Number of events 409 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
24.1%
121/503 • Number of events 409 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
24.5%
61/249 • Number of events 224 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
Weight decreased
|
20.1%
51/254 • Number of events 72 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
15.1%
76/503 • Number of events 104 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
15.1%
76/503 • Number of events 104 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
10.0%
25/249 • Number of events 32 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Investigations
White blood cell count decreased
|
19.7%
50/254 • Number of events 207 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
17.9%
90/503 • Number of events 377 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
17.9%
90/503 • Number of events 377 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
16.1%
40/249 • Number of events 170 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
103/254 • Number of events 195 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
37.4%
188/503 • Number of events 357 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
37.4%
188/503 • Number of events 357 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
34.1%
85/249 • Number of events 162 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.4%
57/254 • Number of events 136 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.3%
92/503 • Number of events 202 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.3%
92/503 • Number of events 202 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
14.1%
35/249 • Number of events 66 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.1%
13/254 • Number of events 17 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.8%
12/249 • Number of events 20 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.4%
34/254 • Number of events 72 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
13.5%
68/503 • Number of events 143 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
13.5%
68/503 • Number of events 143 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
13.7%
34/249 • Number of events 71 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
15/254 • Number of events 20 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.4%
32/503 • Number of events 49 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.4%
32/503 • Number of events 49 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.8%
17/249 • Number of events 29 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
10/254 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.6%
28/503 • Number of events 36 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.6%
28/503 • Number of events 36 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
7.2%
18/249 • Number of events 26 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Dizziness
|
5.5%
14/254 • Number of events 21 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
26/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
26/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.8%
12/249 • Number of events 16 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
18/254 • Number of events 25 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.0%
30/503 • Number of events 38 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.0%
30/503 • Number of events 38 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.8%
12/249 • Number of events 13 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Hypoaesthesia
|
12.2%
31/254 • Number of events 110 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.1%
61/503 • Number of events 212 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.1%
61/503 • Number of events 212 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
12.0%
30/249 • Number of events 102 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.7%
12/254 • Number of events 18 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 37 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
13/249 • Number of events 19 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Neurotoxicity
|
5.5%
14/254 • Number of events 34 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.6%
33/503 • Number of events 69 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.6%
33/503 • Number of events 69 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
7.6%
19/249 • Number of events 35 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.4%
57/254 • Number of events 96 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
22.5%
113/503 • Number of events 215 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
22.5%
113/503 • Number of events 215 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
22.5%
56/249 • Number of events 119 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Psychiatric disorders
Insomnia
|
11.0%
28/254 • Number of events 36 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
9.1%
46/503 • Number of events 55 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
9.1%
46/503 • Number of events 55 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
7.2%
18/249 • Number of events 19 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
12/254 • Number of events 13 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.4%
27/503 • Number of events 32 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.4%
27/503 • Number of events 32 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
6.0%
15/249 • Number of events 19 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
13/254 • Number of events 16 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 33 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 33 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.8%
12/249 • Number of events 17 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.9%
43/254 • Number of events 67 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.3%
92/503 • Number of events 153 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
18.3%
92/503 • Number of events 153 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
19.7%
49/249 • Number of events 86 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Vascular disorders
Hypertension
|
5.9%
15/254 • Number of events 45 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.4%
22/503 • Number of events 52 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.4%
22/503 • Number of events 52 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
2.8%
7/249 • Number of events 7 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
8/254 • Number of events 11 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.2%
21/503 • Number of events 33 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.2%
21/503 • Number of events 33 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.2%
13/249 • Number of events 22 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
13/254 • Number of events 16 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.4%
22/503 • Number of events 26 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
4.4%
22/503 • Number of events 26 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.6%
9/249 • Number of events 10 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.4%
90/254 • Number of events 255 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
35.6%
179/503 • Number of events 480 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
35.6%
179/503 • Number of events 480 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
35.7%
89/249 • Number of events 225 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
17/254 • Number of events 41 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 63 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
5.0%
25/503 • Number of events 63 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
3.2%
8/249 • Number of events 22 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.9%
48/254 • Number of events 131 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
16.3%
82/503 • Number of events 212 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
16.3%
82/503 • Number of events 212 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
13.7%
34/249 • Number of events 81 • All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc
Phone: 8008887704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER