Trial Outcomes & Findings for A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (NCT NCT03504397)
NCT ID: NCT03504397
Last Updated: 2025-11-03
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 (KM) estimates was used.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
565 participants
Primary outcome timeframe
From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)
Results posted on
2025-11-03
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 |
mFOLFOX6 + Zolbetuximab
Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle1 day1(C1D1) followed by 600 mg/m\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \& 29 of each cycle (5-FU:400mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \& Folinic acid on Days 1, 15 \& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Overall Study
STARTED
|
283
|
282
|
|
Overall Study
Participants Who Received at Least One Dose of Study Drug
|
279
|
278
|
|
Overall Study
COMPLETED
|
26
|
17
|
|
Overall Study
NOT COMPLETED
|
257
|
265
|
Reasons for withdrawal
| Measure |
mFOLFOX6 + Zolbetuximab
Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle1 day1(C1D1) followed by 600 mg/m\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \& 29 of each cycle (5-FU:400mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \& Folinic acid on Days 1, 15 \& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
151
|
199
|
|
Overall Study
Withdrawal by Subject
|
29
|
17
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
14
|
16
|
|
Overall Study
Adverse Event
|
40
|
14
|
|
Overall Study
miscellaneous
|
17
|
15
|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Participants who did not take the study drug
|
4
|
4
|
Baseline Characteristics
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Baseline characteristics by cohort
| Measure |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 11.7 • n=3 Participants
|
58.8 Years
STANDARD_DEVIATION 13.0 • n=15 Participants
|
59.3 Years
STANDARD_DEVIATION 12.4 • n=18 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=3 Participants
|
107 Participants
n=15 Participants
|
214 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=3 Participants
|
175 Participants
n=15 Participants
|
351 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=3 Participants
|
37 Participants
n=15 Participants
|
73 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
225 Participants
n=3 Participants
|
213 Participants
n=15 Participants
|
438 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=3 Participants
|
32 Participants
n=15 Participants
|
54 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
17 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=3 Participants
|
97 Participants
n=15 Participants
|
193 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=3 Participants
|
134 Participants
n=15 Participants
|
274 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=3 Participants
|
41 Participants
n=15 Participants
|
74 Participants
n=18 Participants
|
|
Region (Asia vs Non-Asia)
Asia
|
88 Participants
n=3 Participants
|
89 Participants
n=15 Participants
|
177 Participants
n=18 Participants
|
|
Region (Asia vs Non-Asia)
Non- Asia
|
195 Participants
n=3 Participants
|
193 Participants
n=15 Participants
|
388 Participants
n=18 Participants
|
|
Number of organs with metastatic sites
0-2 metastatic sites
|
219 Participants
n=3 Participants
|
219 Participants
n=15 Participants
|
438 Participants
n=18 Participants
|
|
Number of organs with metastatic sites
>=3 metastatic sites
|
64 Participants
n=3 Participants
|
63 Participants
n=15 Participants
|
127 Participants
n=18 Participants
|
|
Prior Gastrectomy
YES
|
84 Participants
n=3 Participants
|
82 Participants
n=15 Participants
|
166 Participants
n=18 Participants
|
|
Prior Gastrectomy
NO
|
199 Participants
n=3 Participants
|
200 Participants
n=15 Participants
|
399 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)Population: 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 (KM) estimates was used.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.04 Months
Interval 9.69 to 12.52
|
8.94 Months
Interval 8.21 to 10.41
|
SECONDARY outcome
Timeframe: From the date of randomization until 62 months and 18 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 |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Overall Survival (OS)
|
18.23 Months
Interval 16.13 to 20.63
|
15.57 Months
Interval 13.67 to 16.92
|
SECONDARY outcome
Timeframe: From the date of randomization until 62 months and 18 daysPopulation: FAS
TTCD: time from randomization to first clinically meaning full deterioration (CMD) that was confirmed at next scheduled visit. EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical,role,emotional,social \& cognitive), 9 symptom scales (fatigue, nausea/vomiting,general pain,dyspnea,insomnia,appetite loss,constipation,diarrhea,financial difficulties) \& global health status scale. Most items were scored 1(not at all) to 4(very much) except for items contributing to global health status/QoL, which were scored 1(very poor) to 7(excellent). All raw domain scores were linearly transformed to 0-100scale with higher scores on symptoms indicate worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -13. This was derived from an Exit Survey conducted using Patient Global Impression of Severity/Change(PGIS/PGIC) questionnaires as an anchor for estimating meaningful change. KM estimates was used.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
|
9.89 Months
Interval 6.01 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.
|
12.32 Months
Interval 9.26 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.
|
SECONDARY outcome
Timeframe: From the date of randomization until 62 months and 18 daysPopulation: FAS
TTCD: time from randomization to first CMD that was confirmed at next scheduled visit. EORTC QLQ-OG25 evaluated gastric and GEJ cancer specific symptoms. A 25 item instrument with 6 scales: dysphagia (3 items), eating restrictions (4 ), reflux (2), odynophagia (2), pain and discomfort (2), anxiety (2), as well as 10 single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight and hair loss. Items were scored:1: not at all; 2: a little, 3: quite a bit, 4: very much, and were transformed linearly into scores (0 to 100) with higher scores indicating worse symptoms. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of 16.67. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25
|
NA Months
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 )
|
NA Months
Interval 15.67 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 )
|
SECONDARY outcome
Timeframe: From the date of randomization until 62 months and 18 daysPopulation: FAS
TTCD: time from randomization to first CMD that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 was 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 were scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which were scored 1 ("very poor") to 7 ("excellent"). All raw domain scores were linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -10. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
|
15.44 Months
Interval 7.06 to 23.89
|
11.83 Months
Interval 9.23 to 15.08
|
SECONDARY outcome
Timeframe: From the date of randomization until 62 months and 18 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 |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=282 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
48.1 Percentage of participants
Interval 42.11 to 54.05
|
47.5 Percentage of participants
Interval 41.56 to 53.52
|
SECONDARY outcome
Timeframe: From date of first response (CR/PR) until 62 months and 18 dayPopulation: 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 sudy.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=136 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=134 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Duration Of Response (DOR)
|
9.00 Months
Interval 7.49 to 10.38
|
8.11 Months
Interval 6.47 to 11.37
|
SECONDARY outcome
Timeframe: From first dose until 62 months and 18 daysPopulation: Safety analysis set (SAF) included all participants who received at least 1 dose of any study drug (zolbetuximab/placebo and mFOLFOX6).
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 notconsidered 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 |
mFOLFOX6 + Zolbetuximab
n=279 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=278 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
278 Participants
|
277 Participants
|
SECONDARY outcome
Timeframe: Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39Population: FAS with available data was analyzed.
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 |
mFOLFOX6 + Zolbetuximab
n=279 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=278 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 1
|
25 Participants
|
16 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 0
|
26 Participants
|
22 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 1
|
34 Participants
|
17 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 0
|
23 Participants
|
14 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 1
|
29 Participants
|
12 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 1
|
24 Participants
|
17 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 0
|
18 Participants
|
12 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 1
|
19 Participants
|
10 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 0
|
20 Participants
|
13 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 0
|
14 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 1
|
18 Participants
|
7 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 1
|
10 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 0
|
6 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 1
|
7 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 0
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 0
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 1
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 0
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 1
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 1
|
101 Participants
|
101 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 0
|
70 Participants
|
70 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 0
|
57 Participants
|
53 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 1
|
67 Participants
|
82 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 2
|
5 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C5D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 0
|
66 Participants
|
57 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 1
|
82 Participants
|
84 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 2
|
3 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 0
|
51 Participants
|
50 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 1
|
67 Participants
|
59 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C6D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 0
|
65 Participants
|
55 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 1
|
70 Participants
|
58 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 0
|
53 Participants
|
52 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 1
|
62 Participants
|
46 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 0
|
40 Participants
|
34 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 1
|
41 Participants
|
29 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 0
|
37 Participants
|
43 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 1
|
47 Participants
|
35 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C8D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 0
|
45 Participants
|
40 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 1
|
48 Participants
|
34 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 0
|
33 Participants
|
37 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C9D22 Score 1
|
42 Participants
|
28 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 0
|
24 Participants
|
17 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 0
|
46 Participants
|
45 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 1
|
56 Participants
|
45 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C7D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 0
|
29 Participants
|
25 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 1
|
38 Participants
|
23 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 0
|
36 Participants
|
23 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 1
|
39 Participants
|
29 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 0
|
26 Participants
|
22 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 1
|
35 Participants
|
17 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C11D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 0
|
28 Participants
|
27 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 1
|
37 Participants
|
19 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C12D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C10D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 0
|
23 Participants
|
18 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C13D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C14D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 0
|
19 Participants
|
15 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 1
|
24 Participants
|
15 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 0
|
15 Participants
|
12 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C15D22 Score 1
|
21 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 0
|
15 Participants
|
10 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 1
|
18 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 1
|
21 Participants
|
12 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C16D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 0
|
9 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 1
|
13 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C17D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 0
|
13 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 1
|
17 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 1
|
12 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 0
|
9 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 0
|
11 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 1
|
10 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C18D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 0
|
9 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 0
|
9 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 1
|
16 Participants
|
8 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 0
|
7 Participants
|
7 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 1
|
11 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C19D1 Score 1
|
17 Participants
|
7 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 1
|
14 Participants
|
7 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 0
|
4 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 1
|
10 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C20D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D1 Score 0
|
8 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C21D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 0
|
125 Participants
|
115 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 1
|
153 Participants
|
163 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 0
|
83 Participants
|
102 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 1
|
116 Participants
|
133 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 2
|
8 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C1D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 0
|
103 Participants
|
112 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 1
|
127 Participants
|
144 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 2
|
8 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 0
|
64 Participants
|
78 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 1
|
113 Participants
|
123 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C2D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 0
|
94 Participants
|
91 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 1
|
118 Participants
|
132 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 2
|
10 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 0
|
78 Participants
|
65 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 1
|
97 Participants
|
104 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 2
|
4 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C3D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 0
|
78 Participants
|
79 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 1
|
118 Participants
|
115 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 2
|
5 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 0
|
49 Participants
|
54 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 1
|
84 Participants
|
89 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 2
|
6 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C4D22 Score 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 0
|
3 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 1
|
7 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 0
|
5 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 0
|
4 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 1
|
9 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C23D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 1
|
10 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 0
|
2 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 1
|
7 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C24D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 0
|
4 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 1
|
10 Participants
|
5 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 0
|
2 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 1
|
9 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C25D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 0
|
3 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 1
|
10 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 0
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 1
|
6 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C26D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 0
|
3 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 1
|
10 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 0
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 1
|
7 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C27D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 0
|
4 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 1
|
9 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 0
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 1
|
7 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C28D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 0
|
4 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 1
|
6 Participants
|
3 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 0
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 1
|
5 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C29D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 0
|
3 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 0
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 1
|
6 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C30D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 0
|
3 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 1
|
5 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 0
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 1
|
4 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C31D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 1
|
5 Participants
|
2 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 0
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 1
|
4 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 0
|
6 Participants
|
4 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C32D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 1
|
3 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 1
|
10 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 1
|
2 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C33D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C22D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 0
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C34D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 1
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C35D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D1 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C36D22 Score 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 1
|
2 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D1 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C37D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D1 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C38D22 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D1 Score 5
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 0
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 1
|
1 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 2
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 3
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 4
|
0 Participants
|
—
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
C39D22 Score 5
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow upPopulation: FAS with available data was analyzed.
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.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=257 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=258 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C2D1
|
1.61 units on Scale
Standard Deviation 20.40
|
5.56 units on Scale
Standard Deviation 18.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C2D22
|
0.17 units on Scale
Standard Deviation 18.51
|
1.98 units on Scale
Standard Deviation 20.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C4D22
|
-2.78 units on Scale
Standard Deviation 18.16
|
1.50 units on Scale
Standard Deviation 22.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C5D1
|
-0.62 units on Scale
Standard Deviation 20.69
|
4.83 units on Scale
Standard Deviation 20.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C5D22
|
0.53 units on Scale
Standard Deviation 21.24
|
0.07 units on Scale
Standard Deviation 21.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C6D1
|
1.90 units on Scale
Standard Deviation 20.66
|
0.07 units on Scale
Standard Deviation 21.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C6D22
|
3.48 units on Scale
Standard Deviation 18.21
|
2.39 units on Scale
Standard Deviation 18.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C7D22
|
1.54 units on Scale
Standard Deviation 18.50
|
3.38 units on Scale
Standard Deviation 20.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C8D22
|
1.62 units on Scale
Standard Deviation 19.91
|
6.92 units on Scale
Standard Deviation 18.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C9D1
|
6.11 units on Scale
Standard Deviation 18.09
|
4.57 units on Scale
Standard Deviation 15.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C9D22
|
3.33 units on Scale
Standard Deviation 19.54
|
3.18 units on Scale
Standard Deviation 17.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C10D1
|
3.03 units on Scale
Standard Deviation 18.87
|
3.87 units on Scale
Standard Deviation 19.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C10D22
|
0.58 units on Scale
Standard Deviation 19.47
|
5.43 units on Scale
Standard Deviation 17.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C11D1
|
4.37 units on Scale
Standard Deviation 16.92
|
3.99 units on Scale
Standard Deviation 15.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C11D22
|
2.65 units on Scale
Standard Deviation 18.31
|
1.34 units on Scale
Standard Deviation 16.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C13D1
|
3.47 units on Scale
Standard Deviation 18.18
|
0.95 units on Scale
Standard Deviation 13.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C13D22
|
-2.85 units on Scale
Standard Deviation 19.24
|
-0.79 units on Scale
Standard Deviation 13.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C17D1
|
-3.89 units on Scale
Standard Deviation 28.68
|
0.93 units on Scale
Standard Deviation 13.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C17D22
|
-6.88 units on Scale
Standard Deviation 25.33
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C18D1
|
0.00 units on Scale
Standard Deviation 24.57
|
-1.56 units on Scale
Standard Deviation 13.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C18D22
|
-7.14 units on Scale
Standard Deviation 21.94
|
-1.67 units on Scale
Standard Deviation 12.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C19D1
|
-3.62 units on Scale
Standard Deviation 24.60
|
-6.11 units on Scale
Standard Deviation 14.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C20D22
|
-3.70 units on Scale
Standard Deviation 22.18
|
-0.83 units on Scale
Standard Deviation 15.93
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C21D1
|
2.08 units on Scale
Standard Deviation 20.75
|
-1.79 units on Scale
Standard Deviation 15.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C21D22
|
-4.17 units on Scale
Standard Deviation 17.83
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C22D1
|
-0.56 units on Scale
Standard Deviation 24.29
|
-6.25 units on Scale
Standard Deviation 14.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C23D1
|
-4.17 units on Scale
Standard Deviation 29.03
|
-0.64 units on Scale
Standard Deviation 15.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C23D22
|
-3.79 units on Scale
Standard Deviation 22.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status 30 Day follow up
|
-4.98 units on Scale
Standard Deviation 21.20
|
-4.03 units on Scale
Standard Deviation 20.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status 90 Day follow up
|
-5.72 units on Scale
Standard Deviation 21.55
|
-4.62 units on Scale
Standard Deviation 22.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C2D22
|
-0.98 units on Scale
Standard Deviation 17.69
|
1.73 units on Scale
Standard Deviation 18.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C3D1
|
-0.84 units on Scale
Standard Deviation 19.51
|
2.66 units on Scale
Standard Deviation 18.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C4D22
|
-2.60 units on Scale
Standard Deviation 19.87
|
-1.51 units on Scale
Standard Deviation 19.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C5D1
|
-3.00 units on Scale
Standard Deviation 22.55
|
0.55 units on Scale
Standard Deviation 18.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C6D1
|
-1.08 units on Scale
Standard Deviation 20.91
|
-1.26 units on Scale
Standard Deviation 18.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C7D22
|
-2.14 units on Scale
Standard Deviation 18.67
|
1.89 units on Scale
Standard Deviation 19.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C8D1
|
0.33 units on Scale
Standard Deviation 21.87
|
0.88 units on Scale
Standard Deviation 15.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C8D22
|
1.02 units on Scale
Standard Deviation 18.84
|
-0.31 units on Scale
Standard Deviation 17.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C10D1
|
2.53 units on Scale
Standard Deviation 21.65
|
0.71 units on Scale
Standard Deviation 16.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C11D1
|
3.60 units on Scale
Standard Deviation 20.17
|
-3.33 units on Scale
Standard Deviation 16.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C12D1
|
2.26 units on Scale
Standard Deviation 20.08
|
-3.58 units on Scale
Standard Deviation 14.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C12D22
|
2.63 units on Scale
Standard Deviation 20.65
|
-5.60 units on Scale
Standard Deviation 14.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C13D1
|
3.06 units on Scale
Standard Deviation 20.35
|
-6.67 units on Scale
Standard Deviation 17.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C13D22
|
1.46 units on Scale
Standard Deviation 21.63
|
-6.98 units on Scale
Standard Deviation 19.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C14D1
|
4.27 units on Scale
Standard Deviation 17.27
|
-3.56 units on Scale
Standard Deviation 13.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C17D1
|
3.78 units on Scale
Standard Deviation 25.05
|
-3.70 units on Scale
Standard Deviation 11.93
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C18D1
|
3.46 units on Scale
Standard Deviation 21.03
|
-2.92 units on Scale
Standard Deviation 6.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C19D22
|
-1.00 units on Scale
Standard Deviation 18.39
|
-4.24 units on Scale
Standard Deviation 8.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C20D1
|
0.29 units on Scale
Standard Deviation 22.43
|
-1.78 units on Scale
Standard Deviation 8.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C20D22
|
-1.48 units on Scale
Standard Deviation 24.37
|
-4.67 units on Scale
Standard Deviation 7.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C21D1
|
2.33 units on Scale
Standard Deviation 15.18
|
-1.43 units on Scale
Standard Deviation 9.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C22D22
|
-5.45 units on Scale
Standard Deviation 24.00
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C23D1
|
-3.33 units on Scale
Standard Deviation 19.78
|
1.54 units on Scale
Standard Deviation 9.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C24D1
|
-3.81 units on Scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C25D1
|
5.00 units on Scale
Standard Deviation 11.42
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C27D1
|
3.64 units on Scale
Standard Deviation 15.88
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C28D1
|
1.67 units on Scale
Standard Deviation 15.86
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning Baseline
|
74.77 units on Scale
Standard Deviation 27.56
|
75.52 units on Scale
Standard Deviation 28.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C3D22
|
-3.73 units on Scale
Standard Deviation 25.96
|
-0.89 units on Scale
Standard Deviation 25.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C4D1
|
-1.18 units on Scale
Standard Deviation 28.41
|
1.94 units on Scale
Standard Deviation 26.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C4D22
|
-2.98 units on Scale
Standard Deviation 28.39
|
-2.73 units on Scale
Standard Deviation 24.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C5D1
|
-4.25 units on Scale
Standard Deviation 29.71
|
-2.87 units on Scale
Standard Deviation 27.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C6D1
|
-1.76 units on Scale
Standard Deviation 29.94
|
-5.46 units on Scale
Standard Deviation 26.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C6D22
|
-4.21 units on Scale
Standard Deviation 29.59
|
-2.84 units on Scale
Standard Deviation 25.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C9D22
|
-0.83 units on Scale
Standard Deviation 30.13
|
-0.61 units on Scale
Standard Deviation 22.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C11D1
|
1.32 units on Scale
Standard Deviation 32.56
|
-0.36 units on Scale
Standard Deviation 21.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C11D22
|
-3.79 units on Scale
Standard Deviation 28.27
|
-9.14 units on Scale
Standard Deviation 20.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C14D22
|
-3.65 units on Scale
Standard Deviation 27.67
|
-2.63 units on Scale
Standard Deviation 20.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C15D1
|
-1.90 units on Scale
Standard Deviation 27.94
|
-5.56 units on Scale
Standard Deviation 24.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C15D22
|
-5.00 units on Scale
Standard Deviation 31.00
|
5.88 units on Scale
Standard Deviation 22.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C19D1
|
-3.62 units on Scale
Standard Deviation 24.60
|
-5.56 units on Scale
Standard Deviation 19.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C20D22
|
-6.48 units on Scale
Standard Deviation 33.40
|
-6.67 units on Scale
Standard Deviation 11.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C24D1
|
-7.14 units on Scale
Standard Deviation 26.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C25D1
|
-4.17 units on Scale
Standard Deviation 20.26
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C25D22
|
-12.12 units on Scale
Standard Deviation 18.40
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C27D1
|
-6.06 units on Scale
Standard Deviation 22.70
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C28D1
|
-6.94 units on Scale
Standard Deviation 24.06
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C1D22
|
0.85 units on Scale
Standard Deviation 19.08
|
3.33 units on Scale
Standard Deviation 15.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C2D1
|
4.55 units on Scale
Standard Deviation 20.49
|
6.15 units on Scale
Standard Deviation 17.93
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C3D1
|
6.27 units on Scale
Standard Deviation 20.28
|
9.43 units on Scale
Standard Deviation 18.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C4D22
|
2.71 units on Scale
Standard Deviation 19.46
|
6.84 units on Scale
Standard Deviation 20.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C5D1
|
4.19 units on Scale
Standard Deviation 24.21
|
5.80 units on Scale
Standard Deviation 20.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C5D22
|
4.35 units on Scale
Standard Deviation 24.04
|
2.95 units on Scale
Standard Deviation 18.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C6D1
|
6.44 units on Scale
Standard Deviation 24.56
|
4.92 units on Scale
Standard Deviation 17.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C6D22
|
5.50 units on Scale
Standard Deviation 21.44
|
7.54 units on Scale
Standard Deviation 17.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C7D1
|
5.70 units on Scale
Standard Deviation 22.24
|
7.99 units on Scale
Standard Deviation 19.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C7D22
|
3.70 units on Scale
Standard Deviation 20.20
|
7.66 units on Scale
Standard Deviation 18.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C8D1
|
5.21 units on Scale
Standard Deviation 19.64
|
9.14 units on Scale
Standard Deviation 19.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C8D22
|
7.29 units on Scale
Standard Deviation 24.58
|
6.41 units on Scale
Standard Deviation 20.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C9D1
|
8.67 units on Scale
Standard Deviation 23.86
|
6.99 units on Scale
Standard Deviation 16.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C9D22
|
6.11 units on Scale
Standard Deviation 25.25
|
5.76 units on Scale
Standard Deviation 18.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C10D1
|
7.20 units on Scale
Standard Deviation 23.97
|
6.85 units on Scale
Standard Deviation 18.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C10D22
|
8.04 units on Scale
Standard Deviation 22.27
|
6.20 units on Scale
Standard Deviation 20.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C11D1
|
9.13 units on Scale
Standard Deviation 20.83
|
3.99 units on Scale
Standard Deviation 21.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C11D22
|
8.33 units on Scale
Standard Deviation 17.88
|
1.88 units on Scale
Standard Deviation 22.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C12D1
|
9.59 units on Scale
Standard Deviation 19.57
|
2.44 units on Scale
Standard Deviation 18.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C7D1
|
-2.49 units on Scale
Standard Deviation 19.36
|
-3.57 units on Scale
Standard Deviation 17.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C13D1
|
7.99 units on Scale
Standard Deviation 23.44
|
1.43 units on Scale
Standard Deviation 24.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C13D22
|
3.86 units on Scale
Standard Deviation 20.34
|
-3.17 units on Scale
Standard Deviation 19.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C14D1
|
6.20 units on Scale
Standard Deviation 21.61
|
2.22 units on Scale
Standard Deviation 18.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C14D22
|
3.65 units on Scale
Standard Deviation 21.27
|
-1.75 units on Scale
Standard Deviation 18.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C15D1
|
6.43 units on Scale
Standard Deviation 21.49
|
2.47 units on Scale
Standard Deviation 18.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C15D22
|
4.17 units on Scale
Standard Deviation 16.63
|
-2.45 units on Scale
Standard Deviation 20.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C16D1
|
9.76 units on Scale
Standard Deviation 21.81
|
-3.41 units on Scale
Standard Deviation 21.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C16D22
|
6.03 units on Scale
Standard Deviation 19.02
|
-4.76 units on Scale
Standard Deviation 20.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C17D1
|
7.50 units on Scale
Standard Deviation 28.90
|
3.70 units on Scale
Standard Deviation 19.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C17D22
|
7.25 units on Scale
Standard Deviation 23.21
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C18D1
|
8.33 units on Scale
Standard Deviation 20.28
|
2.60 units on Scale
Standard Deviation 20.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C8D1
|
-0.83 units on Scale
Standard Deviation 21.53
|
3.01 units on Scale
Standard Deviation 22.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C18D22
|
5.95 units on Scale
Standard Deviation 18.47
|
-5.00 units on Scale
Standard Deviation 21.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C19D22
|
4.17 units on Scale
Standard Deviation 24.26
|
-3.79 units on Scale
Standard Deviation 20.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C20D1
|
10.51 units on Scale
Standard Deviation 17.27
|
2.78 units on Scale
Standard Deviation 20.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C20D22
|
8.80 units on Scale
Standard Deviation 17.26
|
-6.67 units on 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
|
11.25 units on Scale
Standard Deviation 18.39
|
-2.98 units on Scale
Standard Deviation 24.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C21D22
|
6.55 units on Scale
Standard Deviation 16.40
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C22D1
|
11.67 units on Scale
Standard Deviation 16.61
|
2.78 units on Scale
Standard Deviation 21.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C9D1
|
2.67 units on Scale
Standard Deviation 21.05
|
3.23 units on Scale
Standard Deviation 25.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C24D1
|
14.88 units on Scale
Standard Deviation 20.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C25D1
|
9.03 units on Scale
Standard Deviation 21.75
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C28D1
|
14.58 units on Scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning 90 Day follow up
|
-1.74 units on Scale
Standard Deviation 22.69
|
-4.02 units on Scale
Standard Deviation 23.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning Baseline
|
87.48 units on Scale
Standard Deviation 17.62
|
86.69 units on Scale
Standard Deviation 18.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C2D1
|
-0.16 units on Scale
Standard Deviation 19.57
|
0.30 units on Scale
Standard Deviation 15.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C2D22
|
-1.00 units on Scale
Standard Deviation 16.75
|
-1.10 units on Scale
Standard Deviation 15.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C3D1
|
-0.61 units on Scale
Standard Deviation 20.67
|
-0.17 units on Scale
Standard Deviation 16.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C4D22
|
-5.28 units on Scale
Standard Deviation 21.59
|
-1.82 units on Scale
Standard Deviation 16.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C5D1
|
-4.03 units on Scale
Standard Deviation 21.19
|
-3.56 units on Scale
Standard Deviation 17.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C5D22
|
-4.35 units on Scale
Standard Deviation 23.54
|
-3.16 units on Scale
Standard Deviation 16.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C6D1
|
-5.42 units on Scale
Standard Deviation 24.00
|
-3.13 units on Scale
Standard Deviation 17.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C6D22
|
-2.27 units on Scale
Standard Deviation 23.46
|
-0.71 units on Scale
Standard Deviation 14.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C7D22
|
-2.06 units on Scale
Standard Deviation 18.33
|
-0.45 units on Scale
Standard Deviation 16.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C8D1
|
-3.75 units on Scale
Standard Deviation 21.38
|
-2.61 units on Scale
Standard Deviation 16.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C8D22
|
1.16 units on Scale
Standard Deviation 22.08
|
-5.90 units on Scale
Standard Deviation 20.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C9D1
|
-0.67 units on Scale
Standard Deviation 22.67
|
-2.15 units on Scale
Standard Deviation 17.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C9D22
|
-1.67 units on Scale
Standard Deviation 24.10
|
0.91 units on Scale
Standard Deviation 18.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C10D1
|
-0.25 units on Scale
Standard Deviation 23.11
|
-2.68 units on Scale
Standard Deviation 17.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C10D22
|
-1.17 units on Scale
Standard Deviation 19.63
|
-3.10 units on Scale
Standard Deviation 21.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C11D1
|
2.12 units on Scale
Standard Deviation 19.74
|
-2.90 units on Scale
Standard Deviation 20.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C11D22
|
-2.27 units on Scale
Standard Deviation 15.91
|
-4.30 units on Scale
Standard Deviation 19.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C12D1
|
0.00 units on Scale
Standard Deviation 18.20
|
-1.63 units on Scale
Standard Deviation 18.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C12D22
|
-1.75 units on Scale
Standard Deviation 19.68
|
-6.00 units on Scale
Standard Deviation 15.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C13D1
|
1.04 units on Scale
Standard Deviation 18.96
|
-5.24 units on Scale
Standard Deviation 28.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C13D22
|
-1.22 units on Scale
Standard Deviation 20.20
|
-1.59 units on Scale
Standard Deviation 25.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C14D1
|
0.43 units on Scale
Standard Deviation 18.92
|
-3.89 units on Scale
Standard Deviation 20.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C15D1
|
-1.43 units on Scale
Standard Deviation 24.04
|
1.23 units on Scale
Standard Deviation 15.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C15D22
|
-0.56 units on Scale
Standard Deviation 17.22
|
3.92 units on Scale
Standard Deviation 24.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C16D1
|
1.43 units on Scale
Standard Deviation 18.24
|
-2.27 units on Scale
Standard Deviation 26.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C17D1
|
-0.56 units on Scale
Standard Deviation 25.70
|
-2.78 units on Scale
Standard Deviation 16.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C17D22
|
-2.17 units on Scale
Standard Deviation 23.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C18D1
|
-0.62 units on Scale
Standard Deviation 19.87
|
0.00 units on Scale
Standard Deviation 10.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C18D22
|
0.00 units on Scale
Standard Deviation 20.41
|
-3.33 units on Scale
Standard Deviation 10.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C19D1
|
-1.45 units on Scale
Standard Deviation 18.74
|
-2.22 units on Scale
Standard Deviation 10.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C19D22
|
-5.00 units on Scale
Standard Deviation 20.30
|
1.52 units on Scale
Standard Deviation 11.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C20D1
|
-2.90 units on Scale
Standard Deviation 19.24
|
1.11 units on Scale
Standard Deviation 11.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C20D22
|
0.93 units on Scale
Standard Deviation 17.59
|
0.00 units on Scale
Standard Deviation 7.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C21D1
|
0.00 units on Scale
Standard Deviation 15.29
|
-2.38 units on Scale
Standard Deviation 12.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C21D22
|
-2.38 units on Scale
Standard Deviation 14.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C22D1
|
0.00 units on Scale
Standard Deviation 16.67
|
-1.39 units on Scale
Standard Deviation 13.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C23D1
|
-1.04 units on Scale
Standard Deviation 17.71
|
2.56 units on Scale
Standard Deviation 9.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C25D22
|
0.00 units on 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
|
6.06 units on Scale
Standard Deviation 18.67
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C28D1
|
4.17 units on Scale
Standard Deviation 18.97
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning 30 Day follow up
|
-8.56 units on Scale
Standard Deviation 24.54
|
-6.41 units on Scale
Standard Deviation 17.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning 90 Day follow up
|
-11.63 units on Scale
Standard Deviation 21.25
|
-7.83 units on Scale
Standard Deviation 20.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning Baseline
|
75.36 units on Scale
Standard Deviation 25.77
|
73.26 units on Scale
Standard Deviation 27.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C1D22
|
-3.11 units on Scale
Standard Deviation 24.13
|
0.48 units on Scale
Standard Deviation 23.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C2D1
|
-0.32 units on Scale
Standard Deviation 24.24
|
3.11 units on Scale
Standard Deviation 25.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C2D22
|
-2.44 units on Scale
Standard Deviation 23.04
|
2.76 units on Scale
Standard Deviation 27.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C4D1
|
0.20 units on Scale
Standard Deviation 24.86
|
5.62 units on Scale
Standard Deviation 23.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C9D22
|
2.78 units on Scale
Standard Deviation 21.52
|
3.33 units on Scale
Standard Deviation 26.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C10D1
|
3.03 units on Scale
Standard Deviation 23.19
|
-0.60 units on Scale
Standard Deviation 28.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C10D22
|
2.34 units on Scale
Standard Deviation 21.69
|
-1.55 units on Scale
Standard Deviation 30.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C11D1
|
3.70 units on Scale
Standard Deviation 21.88
|
1.81 units on Scale
Standard Deviation 25.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C12D1
|
4.09 units on Scale
Standard Deviation 17.87
|
0.00 units on Scale
Standard Deviation 26.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C12D22
|
-1.32 units on Scale
Standard Deviation 21.71
|
4.00 units on Scale
Standard Deviation 22.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C13D1
|
2.43 units on Scale
Standard Deviation 21.19
|
1.43 units on Scale
Standard Deviation 26.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C13D22
|
1.22 units on Scale
Standard Deviation 23.39
|
8.73 units on Scale
Standard Deviation 22.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C14D1
|
2.99 units on Scale
Standard Deviation 22.25
|
0.56 units on Scale
Standard Deviation 25.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C14D22
|
0.52 units on Scale
Standard Deviation 20.52
|
6.14 units on Scale
Standard Deviation 23.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C15D22
|
3.89 units on Scale
Standard Deviation 20.38
|
0.00 units on Scale
Standard Deviation 22.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C17D1
|
1.67 units on Scale
Standard Deviation 26.75
|
4.63 units on Scale
Standard Deviation 26.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C17D22
|
-3.62 units on Scale
Standard Deviation 22.45
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C24D1
|
2.38 units on Scale
Standard Deviation 23.44
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C25D1
|
2.78 units on Scale
Standard Deviation 29.16
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C25D22
|
3.03 units on Scale
Standard Deviation 19.46
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C26D1
|
2.56 units on Scale
Standard Deviation 21.35
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C3D22
|
8.48 units on Scale
Standard Deviation 23.15
|
-0.37 units on Scale
Standard Deviation 21.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C4D1
|
1.70 units on Scale
Standard Deviation 25.04
|
-1.30 units on Scale
Standard Deviation 23.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C4D22
|
5.96 units on Scale
Standard Deviation 24.03
|
-1.48 units on Scale
Standard Deviation 22.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C5D1
|
4.85 units on Scale
Standard Deviation 26.79
|
0.38 units on Scale
Standard Deviation 24.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C5D22
|
5.61 units on Scale
Standard Deviation 27.94
|
1.82 units on Scale
Standard Deviation 25.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C6D1
|
1.08 units on Scale
Standard Deviation 25.66
|
2.00 units on Scale
Standard Deviation 22.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C6D22
|
2.05 units on Scale
Standard Deviation 24.74
|
-0.35 units on Scale
Standard Deviation 21.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C7D1
|
0.78 units on Scale
Standard Deviation 22.74
|
-1.81 units on Scale
Standard Deviation 21.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C7D22
|
4.53 units on Scale
Standard Deviation 22.21
|
-1.35 units on Scale
Standard Deviation 21.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C8D1
|
-0.14 units on Scale
Standard Deviation 23.95
|
-1.34 units on Scale
Standard Deviation 23.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C9D1
|
-4.30 units on Scale
Standard Deviation 22.81
|
-3.58 units on Scale
Standard Deviation 21.55
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C9D22
|
-0.74 units on Scale
Standard Deviation 24.28
|
-3.23 units on Scale
Standard Deviation 23.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C10D1
|
-1.18 units on Scale
Standard Deviation 23.88
|
-3.97 units on Scale
Standard Deviation 23.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C10D22
|
-0.39 units on Scale
Standard Deviation 21.92
|
0.26 units on Scale
Standard Deviation 22.55
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C11D1
|
-4.23 units on Scale
Standard Deviation 20.30
|
-1.21 units on Scale
Standard Deviation 20.45
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C12D1
|
-3.98 units on Scale
Standard Deviation 19.13
|
0.54 units on Scale
Standard Deviation 20.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C13D22
|
1.36 units on Scale
Standard Deviation 23.07
|
2.65 units on Scale
Standard Deviation 16.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C14D1
|
0.00 units on Scale
Standard Deviation 20.71
|
1.48 units on Scale
Standard Deviation 20.37
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C15D1
|
3.49 units on Scale
Standard Deviation 25.25
|
4.94 units on Scale
Standard Deviation 23.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C16D22
|
1.53 units on Scale
Standard Deviation 27.33
|
2.38 units on Scale
Standard Deviation 23.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C17D1
|
1.85 units on Scale
Standard Deviation 22.24
|
-0.62 units on Scale
Standard Deviation 23.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C17D22
|
8.70 units on Scale
Standard Deviation 26.58
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C18D1
|
-2.88 units on Scale
Standard Deviation 18.64
|
-2.78 units on Scale
Standard Deviation 21.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C18D22
|
-4.23 units on Scale
Standard Deviation 17.73
|
1.11 units on Scale
Standard Deviation 20.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C19D1
|
-0.48 units on Scale
Standard Deviation 23.08
|
2.96 units on Scale
Standard Deviation 25.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C20D1
|
1.45 units on Scale
Standard Deviation 26.65
|
-1.48 units on Scale
Standard Deviation 15.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C20D22
|
4.32 units on Scale
Standard Deviation 29.80
|
2.22 units on Scale
Standard Deviation 18.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C22D1
|
5.19 units on Scale
Standard Deviation 20.52
|
2.78 units on Scale
Standard Deviation 17.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C22D22
|
9.09 units on Scale
Standard Deviation 29.32
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C23D1
|
11.11 units on Scale
Standard Deviation 22.22
|
-1.71 units on Scale
Standard Deviation 19.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C26D1
|
3.42 units on Scale
Standard Deviation 17.79
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C27D1
|
1.01 units on Scale
Standard Deviation 14.45
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue 30 Day follow up
|
8.02 units on Scale
Standard Deviation 26.32
|
6.96 units on Scale
Standard Deviation 25.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue 90 Day follow up
|
11.63 units on Scale
Standard Deviation 29.12
|
13.25 units on Scale
Standard Deviation 25.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting Baseline
|
15.37 units on Scale
Standard Deviation 23.90
|
17.18 units on Scale
Standard Deviation 24.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C2D1
|
3.38 units on Scale
Standard Deviation 25.90
|
-3.70 units on Scale
Standard Deviation 23.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C2D22
|
4.33 units on Scale
Standard Deviation 23.76
|
0.83 units on Scale
Standard Deviation 26.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C3D1
|
0.53 units on Scale
Standard Deviation 27.43
|
-5.13 units on Scale
Standard Deviation 23.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C3D22
|
4.61 units on Scale
Standard Deviation 24.28
|
-1.68 units on Scale
Standard Deviation 28.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C4D1
|
0.00 units on Scale
Standard Deviation 26.46
|
-4.19 units on Scale
Standard Deviation 23.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C5D22
|
2.40 units on Scale
Standard Deviation 21.65
|
-5.60 units on Scale
Standard Deviation 22.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C6D22
|
-1.13 units on Scale
Standard Deviation 22.54
|
-5.14 units on Scale
Standard Deviation 24.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C7D22
|
2.06 units on Scale
Standard Deviation 21.31
|
-6.53 units on 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 C8D22
|
-1.85 units on Scale
Standard Deviation 22.12
|
-4.10 units on Scale
Standard Deviation 21.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C9D22
|
-0.56 units on Scale
Standard Deviation 20.11
|
-3.94 units on Scale
Standard Deviation 21.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C10D1
|
-2.27 units on Scale
Standard Deviation 21.26
|
-3.87 units on Scale
Standard Deviation 19.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C11D1
|
-4.23 units on Scale
Standard Deviation 20.95
|
-1.81 units on Scale
Standard Deviation 22.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C11D22
|
0.38 units on Scale
Standard Deviation 17.79
|
-3.76 units on Scale
Standard Deviation 24.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C12D1
|
-3.77 units on Scale
Standard Deviation 19.51
|
-1.63 units on Scale
Standard Deviation 25.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C12D22
|
-1.75 units on Scale
Standard Deviation 19.68
|
-3.33 units on Scale
Standard Deviation 24.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C13D1
|
-3.12 units on Scale
Standard Deviation 19.34
|
-3.33 units on Scale
Standard Deviation 23.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C13D22
|
-1.63 units on Scale
Standard Deviation 23.22
|
-7.14 units on Scale
Standard Deviation 24.48
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C14D1
|
-5.13 units on Scale
Standard Deviation 22.99
|
-2.78 units on Scale
Standard Deviation 22.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C15D1
|
-3.33 units on Scale
Standard Deviation 23.50
|
-3.09 units on Scale
Standard Deviation 25.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C18D1
|
-7.41 units on Scale
Standard Deviation 20.84
|
-4.17 units on Scale
Standard Deviation 26.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C18D22
|
-3.17 units on Scale
Standard Deviation 22.12
|
-8.33 units on Scale
Standard Deviation 29.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C19D1
|
-5.07 units on Scale
Standard Deviation 21.58
|
-1.11 units on Scale
Standard Deviation 29.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C19D22
|
-5.00 units on Scale
Standard Deviation 22.36
|
-7.58 units on Scale
Standard Deviation 31.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C20D1
|
-4.35 units on Scale
Standard Deviation 22.60
|
-3.33 units on Scale
Standard Deviation 26.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C21D22
|
-4.76 units on Scale
Standard Deviation 18.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C22D1
|
-2.22 units on Scale
Standard Deviation 20.77
|
-9.72 units on Scale
Standard Deviation 27.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C22D22
|
-6.06 units on Scale
Standard Deviation 25.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting 30 Day Follow up
|
3.24 units on Scale
Standard Deviation 25.12
|
-1.10 units on Scale
Standard Deviation 27.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting 90 Day Follow up
|
0.39 units on Scale
Standard Deviation 22.28
|
-4.42 units on Scale
Standard Deviation 29.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C1D22
|
-2.54 units on Scale
Standard Deviation 23.40
|
-5.48 units on Scale
Standard Deviation 19.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C2D22
|
-7.67 units on Scale
Standard Deviation 24.47
|
-9.21 units on Scale
Standard Deviation 23.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C3D1
|
-9.12 units on Scale
Standard Deviation 25.92
|
-9.18 units on Scale
Standard Deviation 22.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C3D22
|
-8.44 units on Scale
Standard Deviation 24.71
|
-7.61 units on Scale
Standard Deviation 22.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C4D1
|
-9.31 units on Scale
Standard Deviation 24.46
|
-9.41 units on Scale
Standard Deviation 21.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C4D22
|
-5.69 units on Scale
Standard Deviation 23.94
|
-7.94 units on Scale
Standard Deviation 22.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C5D1
|
-5.82 units on Scale
Standard Deviation 26.91
|
-6.55 units on Scale
Standard Deviation 23.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C6D1
|
-7.18 units on Scale
Standard Deviation 27.25
|
-4.64 units on Scale
Standard Deviation 24.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C6D22
|
-5.34 units on Scale
Standard Deviation 23.36
|
-8.16 units on Scale
Standard Deviation 18.89
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C8D22
|
-8.10 units on Scale
Standard Deviation 23.40
|
-5.90 units on Scale
Standard Deviation 17.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C9D1
|
-8.89 units on Scale
Standard Deviation 22.48
|
-6.99 units on Scale
Standard Deviation 18.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C9D22
|
-6.11 units on Scale
Standard Deviation 23.96
|
-3.94 units on Scale
Standard Deviation 21.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C10D1
|
-6.57 units on Scale
Standard Deviation 24.09
|
-2.38 units on Scale
Standard Deviation 25.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C10D22
|
-2.92 units on Scale
Standard Deviation 24.42
|
-2.71 units on Scale
Standard Deviation 24.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C11D1
|
-9.26 units on Scale
Standard Deviation 23.91
|
-3.62 units on Scale
Standard Deviation 18.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C12D22
|
-0.88 units on Scale
Standard Deviation 27.11
|
-5.33 units on Scale
Standard Deviation 20.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C13D1
|
-5.21 units on Scale
Standard Deviation 25.76
|
-2.86 units on Scale
Standard Deviation 20.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C14D22
|
-5.73 units on Scale
Standard Deviation 18.26
|
-10.53 units on Scale
Standard Deviation 26.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C16D1
|
-3.81 units on Scale
Standard Deviation 24.95
|
-4.55 units on Scale
Standard Deviation 22.53
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C16D22
|
-6.32 units on Scale
Standard Deviation 19.11
|
-3.57 units on Scale
Standard Deviation 11.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C18D1
|
-3.09 units on Scale
Standard Deviation 28.13
|
-6.25 units on Scale
Standard Deviation 10.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C18D22
|
-1.59 units on Scale
Standard Deviation 17.40
|
-5.00 units on Scale
Standard Deviation 15.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C19D22
|
0.00 units on Scale
Standard Deviation 16.22
|
-4.55 units on Scale
Standard Deviation 10.78
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C20D1
|
-2.17 units on Scale
Standard Deviation 26.26
|
-3.33 units on Scale
Standard Deviation 15.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C22D22
|
0.00 units on Scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C23D1
|
1.04 units on Scale
Standard Deviation 21.49
|
-6.41 units on Scale
Standard Deviation 14.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C24D1
|
3.57 units on Scale
Standard Deviation 26.29
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C25D1
|
5.56 units on Scale
Standard Deviation 14.79
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C25D22
|
6.06 units on Scale
Standard Deviation 23.89
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C27D1
|
0.00 units on Scale
Standard Deviation 18.26
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C28D1
|
1.39 units on Scale
Standard Deviation 19.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain 90 Day Follow up
|
3.49 units on Scale
Standard Deviation 28.37
|
6.02 units on Scale
Standard Deviation 29.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea Baseline
|
13.23 units on Scale
Standard Deviation 22.97
|
13.70 units on Scale
Standard Deviation 23.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C1D22
|
1.88 units on Scale
Standard Deviation 22.67
|
1.43 units on Scale
Standard Deviation 22.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C2D1
|
0.48 units on Scale
Standard Deviation 20.90
|
0.59 units on Scale
Standard Deviation 20.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C2D22
|
-0.67 units on Scale
Standard Deviation 20.96
|
0.18 units on Scale
Standard Deviation 21.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C3D22
|
1.32 units on Scale
Standard Deviation 21.32
|
2.24 units on Scale
Standard Deviation 21.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C4D1
|
-0.20 units on Scale
Standard Deviation 23.36
|
1.43 units on Scale
Standard Deviation 21.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C4D22
|
2.71 units on Scale
Standard Deviation 20.29
|
0.26 units on Scale
Standard Deviation 20.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C5D1
|
2.24 units on Scale
Standard Deviation 20.75
|
-0.46 units on Scale
Standard Deviation 24.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C6D1
|
0.81 units on Scale
Standard Deviation 22.77
|
3.28 units on Scale
Standard Deviation 22.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C6D22
|
0.65 units on Scale
Standard Deviation 20.86
|
1.42 units on Scale
Standard Deviation 20.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C7D1
|
4.09 units on Scale
Standard Deviation 21.33
|
-1.02 units on Scale
Standard Deviation 19.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C10D1
|
1.52 units on Scale
Standard Deviation 25.10
|
0.00 units on Scale
Standard Deviation 22.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C10D22
|
2.34 units on Scale
Standard Deviation 18.75
|
1.55 units on Scale
Standard Deviation 24.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C11D1
|
-0.53 units on Scale
Standard Deviation 17.45
|
0.00 units on Scale
Standard Deviation 17.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C11D22
|
2.27 units on Scale
Standard Deviation 18.18
|
2.15 units on Scale
Standard Deviation 28.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C12D1
|
4.40 units on Scale
Standard Deviation 16.06
|
0.00 units on Scale
Standard Deviation 21.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C12D22
|
2.63 units on Scale
Standard Deviation 16.22
|
5.33 units on Scale
Standard Deviation 15.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C13D1
|
2.78 units on Scale
Standard Deviation 15.12
|
0.95 units on Scale
Standard Deviation 22.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C13D22
|
3.25 units on Scale
Standard Deviation 16.34
|
-1.59 units on Scale
Standard Deviation 26.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C14D1
|
0.85 units on Scale
Standard Deviation 16.20
|
0.00 units on Scale
Standard Deviation 24.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C14D22
|
0.00 units on Scale
Standard Deviation 16.93
|
-3.51 units on Scale
Standard Deviation 26.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C15D1
|
-0.95 units on Scale
Standard Deviation 20.59
|
-1.23 units on Scale
Standard Deviation 26.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C15D22
|
-2.22 units on Scale
Standard Deviation 14.99
|
-3.92 units on Scale
Standard Deviation 28.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C18D22
|
4.76 units on Scale
Standard Deviation 19.11
|
-3.33 units on Scale
Standard Deviation 18.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C19D1
|
2.90 units on Scale
Standard Deviation 13.90
|
-2.22 units on Scale
Standard Deviation 15.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C19D22
|
3.33 units on Scale
Standard Deviation 14.91
|
0.00 units on Scale
Standard Deviation 25.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C20D1
|
1.45 units on Scale
Standard Deviation 12.22
|
2.22 units on Scale
Standard Deviation 23.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C20D22
|
1.85 units on Scale
Standard Deviation 7.86
|
-6.67 units on Scale
Standard Deviation 14.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C21D1
|
0.00 units on Scale
Standard Deviation 0.00
|
4.76 units on Scale
Standard Deviation 25.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C22D22
|
0.00 units on Scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C23D1
|
6.25 units on Scale
Standard Deviation 21.84
|
0.00 units on Scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C23D22
|
0.00 units on Scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C24D1
|
0.00 units on Scale
Standard Deviation 13.07
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C25D1
|
-5.56 units on Scale
Standard Deviation 12.97
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea 30 Day Follow up
|
4.63 units on Scale
Standard Deviation 23.94
|
5.49 units on Scale
Standard Deviation 21.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea 90 Day Follow up
|
13.57 units on Scale
Standard Deviation 29.98
|
12.05 units on Scale
Standard Deviation 27.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia Baseline
|
27.50 units on Scale
Standard Deviation 28.50
|
29.59 units on Scale
Standard Deviation 28.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C2D22
|
-5.33 units on Scale
Standard Deviation 29.18
|
-8.84 units on Scale
Standard Deviation 28.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C3D22
|
-5.26 units on Scale
Standard Deviation 27.69
|
-10.07 units on Scale
Standard Deviation 31.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C4D1
|
-10.59 units on Scale
Standard Deviation 29.55
|
-11.86 units on Scale
Standard Deviation 30.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C6D22
|
-4.21 units on Scale
Standard Deviation 29.03
|
-12.77 units on Scale
Standard Deviation 30.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C7D1
|
-7.02 units on Scale
Standard Deviation 27.86
|
-11.90 units on Scale
Standard Deviation 28.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C7D22
|
-4.94 units on Scale
Standard Deviation 23.64
|
-13.96 units on Scale
Standard Deviation 25.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C8D1
|
-6.67 units on Scale
Standard Deviation 26.73
|
-8.84 units on Scale
Standard Deviation 29.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C8D22
|
-6.94 units on Scale
Standard Deviation 27.37
|
-14.36 units on Scale
Standard Deviation 24.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C9D22
|
-8.89 units on Scale
Standard Deviation 32.97
|
-11.52 units on Scale
Standard Deviation 30.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C10D1
|
-8.59 units on Scale
Standard Deviation 27.62
|
-8.33 units on Scale
Standard Deviation 33.78
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C10D22
|
-9.94 units on Scale
Standard Deviation 26.70
|
-10.85 units on Scale
Standard Deviation 29.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C11D1
|
-8.99 units on Scale
Standard Deviation 27.57
|
-10.14 units on Scale
Standard Deviation 26.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C11D22
|
-11.36 units on Scale
Standard Deviation 26.84
|
-10.75 units on Scale
Standard Deviation 29.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C12D1
|
-8.18 units on Scale
Standard Deviation 29.17
|
-12.20 units on Scale
Standard Deviation 30.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C12D22
|
-3.51 units on Scale
Standard Deviation 26.61
|
-8.00 units on Scale
Standard Deviation 25.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C13D1
|
-6.25 units on Scale
Standard Deviation 32.73
|
-10.48 units on Scale
Standard Deviation 22.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C13D22
|
-9.76 units on Scale
Standard Deviation 28.13
|
-11.11 units on Scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C14D22
|
-7.29 units on Scale
Standard Deviation 29.00
|
-8.77 units on Scale
Standard Deviation 26.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C15D1
|
-7.62 units on Scale
Standard Deviation 30.34
|
-6.17 units on Scale
Standard Deviation 24.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C16D1
|
-9.52 units on Scale
Standard Deviation 28.66
|
-1.52 units on Scale
Standard Deviation 24.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C16D22
|
-9.20 units on Scale
Standard Deviation 23.40
|
-7.14 units on Scale
Standard Deviation 29.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C17D1
|
-4.44 units on Scale
Standard Deviation 33.60
|
-7.41 units on Scale
Standard Deviation 29.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C17D22
|
-4.35 units on Scale
Standard Deviation 30.66
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C18D1
|
-9.88 units on Scale
Standard Deviation 28.96
|
0.00 units on Scale
Standard Deviation 21.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C18D22
|
-1.59 units on Scale
Standard Deviation 28.82
|
6.67 units on Scale
Standard Deviation 21.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C19D22
|
-8.33 units on Scale
Standard Deviation 28.36
|
12.12 units on Scale
Standard Deviation 22.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C20D1
|
-10.14 units on Scale
Standard Deviation 29.19
|
-4.44 units on Scale
Standard Deviation 21.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C20D22
|
-9.26 units on Scale
Standard Deviation 31.94
|
10.00 units on Scale
Standard Deviation 27.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C21D1
|
-6.67 units on Scale
Standard Deviation 25.59
|
2.38 units on Scale
Standard Deviation 27.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C22D1
|
-6.67 units on Scale
Standard Deviation 25.82
|
2.78 units on Scale
Standard Deviation 22.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C25D1
|
0.00 units on Scale
Standard Deviation 24.62
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C1D22
|
9.04 units on Scale
Standard Deviation 33.05
|
4.13 units on Scale
Standard Deviation 33.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C2D22
|
-1.33 units on Scale
Standard Deviation 34.08
|
0.18 units on Scale
Standard Deviation 35.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C3D1
|
-8.07 units on Scale
Standard Deviation 34.53
|
-8.75 units on Scale
Standard Deviation 31.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C3D22
|
2.19 units on Scale
Standard Deviation 35.71
|
-2.68 units on Scale
Standard Deviation 30.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C4D22
|
1.90 units on Scale
Standard Deviation 38.01
|
-4.95 units on Scale
Standard Deviation 31.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C5D1
|
-4.03 units on Scale
Standard Deviation 35.92
|
-8.28 units on Scale
Standard Deviation 30.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C5D22
|
-0.30 units on Scale
Standard Deviation 37.20
|
-6.03 units on Scale
Standard Deviation 30.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C6D1
|
-6.50 units on Scale
Standard Deviation 37.37
|
-5.19 units on Scale
Standard Deviation 31.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C6D22
|
-6.15 units on Scale
Standard Deviation 39.81
|
-8.51 units on Scale
Standard Deviation 30.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C7D1
|
-9.65 units on Scale
Standard Deviation 36.76
|
-10.20 units on Scale
Standard Deviation 28.48
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C7D22
|
-4.94 units on Scale
Standard Deviation 39.48
|
-11.26 units on Scale
Standard Deviation 31.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C8D1
|
-8.75 units on Scale
Standard Deviation 35.48
|
-8.43 units on Scale
Standard Deviation 28.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C8D22
|
-8.80 units on Scale
Standard Deviation 38.76
|
-4.10 units on Scale
Standard Deviation 28.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C9D1
|
-15.56 units on Scale
Standard Deviation 34.37
|
-5.91 units on Scale
Standard Deviation 32.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C10D22
|
-5.85 units on Scale
Standard Deviation 37.86
|
0.78 units on Scale
Standard Deviation 33.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C12D1
|
-10.69 units on Scale
Standard Deviation 33.83
|
-5.69 units on Scale
Standard Deviation 28.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C12D22
|
1.75 units on Scale
Standard Deviation 31.90
|
-5.33 units on Scale
Standard Deviation 28.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C13D1
|
-9.72 units on Scale
Standard Deviation 33.66
|
-4.76 units on Scale
Standard Deviation 30.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C13D22
|
-5.69 units on Scale
Standard Deviation 39.37
|
7.94 units on Scale
Standard Deviation 29.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C14D1
|
-10.26 units on Scale
Standard Deviation 35.17
|
0.00 units on Scale
Standard Deviation 27.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C17D1
|
-12.22 units on Scale
Standard Deviation 33.31
|
-5.56 units on Scale
Standard Deviation 23.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C17D22
|
-4.35 units on Scale
Standard Deviation 32.26
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C18D1
|
-14.81 units on Scale
Standard Deviation 31.12
|
-4.17 units on Scale
Standard Deviation 29.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C18D22
|
-7.94 units on Scale
Standard Deviation 27.70
|
-10.00 units on Scale
Standard Deviation 27.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C19D1
|
-11.59 units on Scale
Standard Deviation 23.80
|
-2.22 units on Scale
Standard Deviation 29.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C19D22
|
-8.33 units on Scale
Standard Deviation 23.88
|
-6.06 units on Scale
Standard Deviation 25.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C20D1
|
-10.14 units on Scale
Standard Deviation 27.40
|
-8.89 units on Scale
Standard Deviation 23.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C20D22
|
1.85 units on Scale
Standard Deviation 33.28
|
-10.00 units on Scale
Standard Deviation 27.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C21D1
|
-6.67 units on Scale
Standard Deviation 23.20
|
-7.14 units on Scale
Standard Deviation 19.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C21D22
|
-7.14 units on Scale
Standard Deviation 23.31
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C22D1
|
-13.33 units on Scale
Standard Deviation 21.08
|
-11.11 units on Scale
Standard Deviation 25.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C22D22
|
-6.06 units on Scale
Standard Deviation 32.72
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C23D1
|
-6.25 units on Scale
Standard Deviation 25.00
|
-7.69 units on Scale
Standard Deviation 27.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C2322
|
-9.09 units on Scale
Standard Deviation 26.21
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C24D1
|
-11.90 units on Scale
Standard Deviation 24.83
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss 90 Day Follow up
|
-5.04 units on Scale
Standard Deviation 35.62
|
7.63 units on Scale
Standard Deviation 39.07
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C1D22
|
8.66 units on Scale
Standard Deviation 32.96
|
4.44 units on Scale
Standard Deviation 29.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C2D1
|
-0.48 units on Scale
Standard Deviation 33.25
|
-2.37 units on Scale
Standard Deviation 32.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C2D22
|
-2.89 units on Scale
Standard Deviation 31.12
|
0.37 units on Scale
Standard Deviation 31.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C3D1
|
-5.09 units on Scale
Standard Deviation 31.29
|
-2.53 units on Scale
Standard Deviation 30.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C3D22
|
-2.85 units on Scale
Standard Deviation 28.18
|
-0.89 units on Scale
Standard Deviation 31.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C4D1
|
-2.75 units on Scale
Standard Deviation 32.11
|
-1.02 units on Scale
Standard Deviation 28.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C4D22
|
1.08 units on Scale
Standard Deviation 31.92
|
2.08 units on Scale
Standard Deviation 28.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C6D1
|
-2.44 units on Scale
Standard Deviation 28.04
|
0.55 units on Scale
Standard Deviation 28.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C7D22
|
-2.47 units on Scale
Standard Deviation 25.70
|
-4.05 units on Scale
Standard Deviation 32.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C16D22
|
-3.45 units on Scale
Standard Deviation 27.23
|
14.29 units on Scale
Standard Deviation 40.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C2D22
|
4.67 units on Scale
Standard Deviation 24.74
|
0.92 units on Scale
Standard Deviation 22.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C3D22
|
2.19 units on Scale
Standard Deviation 24.16
|
1.57 units on Scale
Standard Deviation 24.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C6D1
|
-2.17 units on Scale
Standard Deviation 22.48
|
-1.37 units on Scale
Standard Deviation 24.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C15D22
|
-3.33 units on Scale
Standard Deviation 20.25
|
0.00 units on Scale
Standard Deviation 16.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C17D22
|
-1.45 units on Scale
Standard Deviation 23.52
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C19D1
|
-1.45 units on Scale
Standard Deviation 32.53
|
0.00 units on Scale
Standard Deviation 25.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C19D22
|
-3.33 units on Scale
Standard Deviation 21.36
|
0.00 units on Scale
Standard Deviation 14.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C22D22
|
-12.12 units on Scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C12D22
|
-2.63 units on Scale
Standard Deviation 30.39
|
2.67 units on Scale
Standard Deviation 25.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C13D22
|
0.81 units on Scale
Standard Deviation 30.27
|
-4.76 units on Scale
Standard Deviation 26.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C17D22
|
5.80 units on Scale
Standard Deviation 16.37
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C19D1
|
0.00 units on Scale
Standard Deviation 17.41
|
8.89 units on Scale
Standard Deviation 26.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C22D22
|
0.00 units on Scale
Standard Deviation 25.82
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C17D1
|
0.56 units on Scale
Standard Deviation 29.84
|
-4.63 units on Scale
Standard Deviation 15.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C17D22
|
2.17 units on Scale
Standard Deviation 31.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C24D1
|
-0.60 units on Scale
Standard Deviation 26.04
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C25D1
|
-6.94 units on Scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C25D22
|
-3.03 units on Scale
Standard Deviation 17.59
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C19D1
|
0.00 units on Scale
Standard Deviation 20.72
|
-1.11 units on Scale
Standard Deviation 13.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C20D22
|
-3.70 units on Scale
Standard Deviation 21.81
|
1.67 units on Scale
Standard Deviation 16.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C21D1
|
-5.83 units on Scale
Standard Deviation 18.95
|
-4.76 units on Scale
Standard Deviation 15.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C21D22
|
-2.38 units on Scale
Standard Deviation 17.12
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C22D1
|
-1.11 units on Scale
Standard Deviation 14.73
|
-4.17 units on Scale
Standard Deviation 12.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C23D22
|
-1.52 units on Scale
Standard Deviation 17.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status Baseline
|
64.20 units on Scale
Standard Deviation 20.86
|
63.47 units on Scale
Standard Deviation 20.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C1D22
|
-5.18 units on Scale
Standard Deviation 20.75
|
0.48 units on Scale
Standard Deviation 17.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C3D1
|
2.85 units on Scale
Standard Deviation 17.89
|
5.77 units on Scale
Standard Deviation 19.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C3D22
|
-3.13 units on Scale
Standard Deviation 19.10
|
3.13 units on Scale
Standard Deviation 18.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C4D1
|
0.64 units on Scale
Standard Deviation 20.49
|
6.65 units on Scale
Standard Deviation 21.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C7D1
|
0.00 units on Scale
Standard Deviation 20.50
|
4.34 units on Scale
Standard Deviation 17.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C8D1
|
3.12 units on Scale
Standard Deviation 19.82
|
4.82 units on Scale
Standard Deviation 17.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C12D1
|
1.89 units on Scale
Standard Deviation 18.82
|
2.64 units on Scale
Standard Deviation 14.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C26D1
|
6.41 units on Scale
Standard Deviation 23.11
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C27D1
|
2.27 units on Scale
Standard Deviation 22.39
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C28D1
|
0.69 units on Scale
Standard Deviation 26.93
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning Baseline
|
79.71 units on Scale
Standard Deviation 20.37
|
78.79 units on Scale
Standard Deviation 21.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C1D22
|
-4.22 units on Scale
Standard Deviation 17.23
|
-1.49 units on Scale
Standard Deviation 15.70
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C2D1
|
-1.90 units on Scale
Standard Deviation 18.80
|
1.69 units on Scale
Standard Deviation 17.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C3D22
|
-1.36 units on Scale
Standard Deviation 17.26
|
1.52 units on Scale
Standard Deviation 15.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C4D1
|
0.12 units on Scale
Standard Deviation 19.69
|
1.47 units on Scale
Standard Deviation 19.25
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C5D22
|
-2.52 units on Scale
Standard Deviation 22.47
|
0.11 units on Scale
Standard Deviation 19.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C6D22
|
-2.01 units on Scale
Standard Deviation 22.59
|
-0.92 units on Scale
Standard Deviation 15.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C7D1
|
-1.35 units on Scale
Standard Deviation 21.67
|
-0.95 units on Scale
Standard Deviation 15.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C9D1
|
2.13 units on Scale
Standard Deviation 20.33
|
0.43 units on Scale
Standard Deviation 17.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C9D22
|
2.78 units on Scale
Standard Deviation 23.46
|
1.94 units on Scale
Standard Deviation 16.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C10D22
|
3.27 units on Scale
Standard Deviation 18.61
|
-2.48 units on Scale
Standard Deviation 19.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C11D22
|
3.33 units on Scale
Standard Deviation 18.72
|
-6.02 units on Scale
Standard Deviation 16.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C14D22
|
0.42 units on Scale
Standard Deviation 19.67
|
-1.75 units on Scale
Standard Deviation 13.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C15D1
|
3.24 units on Scale
Standard Deviation 18.39
|
-6.42 units on Scale
Standard Deviation 18.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C15D22
|
3.56 units on Scale
Standard Deviation 18.26
|
0.39 units on Scale
Standard Deviation 14.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C16D1
|
3.43 units on Scale
Standard Deviation 20.98
|
-4.55 units on Scale
Standard Deviation 18.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C16D22
|
5.29 units on Scale
Standard Deviation 19.39
|
-7.14 units on Scale
Standard Deviation 14.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C17D22
|
-3.19 units on Scale
Standard Deviation 26.20
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C18D22
|
3.17 units on Scale
Standard Deviation 20.83
|
0.00 units on Scale
Standard Deviation 7.03
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C19D1
|
3.48 units on Scale
Standard Deviation 17.39
|
-1.33 units on Scale
Standard Deviation 8.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C21D22
|
-3.33 units on Scale
Standard Deviation 18.07
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C22D1
|
3.11 units on Scale
Standard Deviation 18.83
|
-2.22 units on Scale
Standard Deviation 6.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C23D22
|
1.82 units on Scale
Standard Deviation 15.23
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C25D22
|
2.42 units on Scale
Standard Deviation 15.28
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning C26D1
|
3.08 units on Scale
Standard Deviation 14.56
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning 30 Day follow up
|
-9.26 units on Scale
Standard Deviation 24.63
|
-6.96 units on Scale
Standard Deviation 21.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Physical Functioning 90 Day follow up
|
-13.57 units on Scale
Standard Deviation 23.77
|
-11.49 units on Scale
Standard Deviation 25.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C1D22
|
-6.78 units on Scale
Standard Deviation 25.09
|
-4.13 units on Scale
Standard Deviation 24.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C2D1
|
-0.64 units on Scale
Standard Deviation 26.78
|
0.30 units on Scale
Standard Deviation 25.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C2D22
|
-1.67 units on Scale
Standard Deviation 25.82
|
-1.20 units on Scale
Standard Deviation 28.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C3D1
|
0.96 units on Scale
Standard Deviation 28.02
|
2.19 units on Scale
Standard Deviation 26.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C5D22
|
-2.70 units on Scale
Standard Deviation 30.03
|
-2.73 units on Scale
Standard Deviation 27.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C7D1
|
-5.56 units on Scale
Standard Deviation 28.37
|
-2.55 units on Scale
Standard Deviation 22.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C7D22
|
-5.35 units on Scale
Standard Deviation 29.68
|
-1.58 units on Scale
Standard Deviation 24.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C8D1
|
-2.92 units on Scale
Standard Deviation 29.62
|
-0.60 units on Scale
Standard Deviation 23.20
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C8D22
|
-1.39 units on Scale
Standard Deviation 28.22
|
-1.03 units on Scale
Standard Deviation 21.83
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C9D1
|
4.89 units on Scale
Standard Deviation 26.53
|
-2.96 units on Scale
Standard Deviation 22.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C10D1
|
0.00 units on Scale
Standard Deviation 29.38
|
-3.27 units on Scale
Standard Deviation 26.1
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C10D22
|
-0.58 units on Scale
Standard Deviation 30.37
|
-2.71 units on Scale
Standard Deviation 26.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C12D1
|
-0.63 units on Scale
Standard Deviation 26.55
|
-2.85 units on Scale
Standard Deviation 21.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C12D22
|
-5.26 units on Scale
Standard Deviation 28.24
|
-4.0 units on Scale
Standard Deviation 24.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C13D1
|
-1.04 units on Scale
Standard Deviation 29.86
|
-2.38 units on Scale
Standard Deviation 24.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C13D22
|
-4.88 units on Scale
Standard Deviation 29.40
|
0.00 units on Scale
Standard Deviation 19.0
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C14D1
|
-2.99 units on Scale
Standard Deviation 26.18
|
-5.56 units on Scale
Standard Deviation 20.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C26D1
|
1.28 units on Scale
Standard Deviation 14.37
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain 30 Follow up
|
0.46 units on Scale
Standard Deviation 29.33
|
7.33 units on Scale
Standard Deviation 27.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C12D22
|
-0.88 units on Scale
Standard Deviation 17.41
|
-3.33 units on Scale
Standard Deviation 12.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C14D1
|
-0.85 units on Scale
Standard Deviation 23.48
|
0.83 units on Scale
Standard Deviation 20.22
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C3D1
|
0.35 units on Scale
Standard Deviation 24.24
|
1.01 units on Scale
Standard Deviation 20.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C14D22
|
-1.30 units on Scale
Standard Deviation 19.64
|
-1.32 units on Scale
Standard Deviation 16.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C15D1
|
-0.71 units on Scale
Standard Deviation 26.69
|
0.93 units on Scale
Standard Deviation 16.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C16D1
|
0.48 units on Scale
Standard Deviation 30.38
|
0.00 units on Scale
Standard Deviation 23.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C5D22
|
2.10 units on Scale
Standard Deviation 22.15
|
1.44 units on Scale
Standard Deviation 22.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C16D22
|
-6.32 units on Scale
Standard Deviation 31.94
|
-1.19 units on Scale
Standard Deviation 20.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C17D1
|
-0.56 units on Scale
Standard Deviation 33.76
|
0.00 units on Scale
Standard Deviation 16.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C17D22
|
-11.59 units on Scale
Standard Deviation 36.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C18D1
|
-4.32 units on Scale
Standard Deviation 28.72
|
-1.04 units on Scale
Standard Deviation 14.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C18D22
|
-3.17 units on Scale
Standard Deviation 24.51
|
-1.67 units on Scale
Standard Deviation 14.59
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C15D22
|
-3.89 units on Scale
Standard Deviation 22.92
|
-3.43 units on Scale
Standard Deviation 18.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C16D1
|
1.90 units on Scale
Standard Deviation 20.32
|
1.89 units on Scale
Standard Deviation 18.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C16D22
|
-2.59 units on Scale
Standard Deviation 20.18
|
-2.38 units on Scale
Standard Deviation 14.41
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C7D22
|
4.94 units on Scale
Standard Deviation 19.80
|
-2.25 units on Scale
Standard Deviation 21.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C8D1
|
3.75 units on Scale
Standard Deviation 20.54
|
-0.40 units on Scale
Standard Deviation 21.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C8D22
|
1.85 units on Scale
Standard Deviation 18.46
|
-3.59 units on Scale
Standard Deviation 18.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C9D1
|
1.78 units on Scale
Standard Deviation 18.90
|
-3.23 units on Scale
Standard Deviation 19.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C9D22
|
3.33 units on Scale
Standard Deviation 27.92
|
-3.64 units on Scale
Standard Deviation 21.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C19D22
|
-8.33 units on Scale
Standard Deviation 18.34
|
-3.03 units on Scale
Standard Deviation 19.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C20D1
|
-5.80 units on Scale
Standard Deviation 23.36
|
-4.44 units on Scale
Standard Deviation 20.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C21D1
|
2.50 units on Scale
Standard Deviation 21.81
|
-1.19 units on Scale
Standard Deviation 17.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C21D22
|
-5.95 units on Scale
Standard Deviation 21.29
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C22D1
|
-2.22 units on Scale
Standard Deviation 15.26
|
-2.78 units on Scale
Standard Deviation 18.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C22D22
|
-13.64 units on Scale
Standard Deviation 36.38
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C23D1
|
-6.25 units on Scale
Standard Deviation 28.46
|
1.28 units on Scale
Standard Deviation 12.66
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C23D22
|
-4.55 units on Scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning C26D1
|
-11.54 units on Scale
Standard Deviation 19.70
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning 30 Day follow up
|
-13.19 units on Scale
Standard Deviation 29.46
|
-10.99 units on Scale
Standard Deviation 30.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Role Functioning 90 Day follow up
|
-14.53 units on Scale
Standard Deviation 33.90
|
-14.26 units on Scale
Standard Deviation 29.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning Baseline
|
74.64 units on Scale
Standard Deviation 20.71
|
73.45 units on Scale
Standard Deviation 21.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C2D22
|
5.78 units on Scale
Standard Deviation 19.36
|
5.85 units on Scale
Standard Deviation 18.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C3D22
|
3.62 units on Scale
Standard Deviation 21.14
|
9.06 units on Scale
Standard Deviation 19.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C4D1
|
7.40 units on Scale
Standard Deviation 20.20
|
8.13 units on Scale
Standard Deviation 18.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C16D1
|
1.90 units on Scale
Standard Deviation 13.87
|
-1.52 units on Scale
Standard Deviation 26.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C16D22
|
4.60 units on Scale
Standard Deviation 19.36
|
4.76 units on Scale
Standard Deviation 17.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C17D1
|
2.22 units on Scale
Standard Deviation 17.36
|
0.00 units on Scale
Standard Deviation 16.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C17D22
|
2.90 units on Scale
Standard Deviation 19.88
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C18D1
|
0.00 units on Scale
Standard Deviation 13.07
|
2.08 units on Scale
Standard Deviation 19.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C21D22
|
2.38 units on Scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C22D1
|
-2.22 units on Scale
Standard Deviation 8.61
|
0.00 units on Scale
Standard Deviation 20.10
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C25D22
|
-3.03 units on Scale
Standard Deviation 10.05
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C26D1
|
-2.56 units on Scale
Standard Deviation 9.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C27D1
|
0.00 units on Scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Dyspnoea C28D1
|
-2.78 units on Scale
Standard Deviation 9.62
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C1D22
|
0.00 units on Scale
Standard Deviation 27.52
|
-3.81 units on Scale
Standard Deviation 29.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C2D1
|
-4.03 units on Scale
Standard Deviation 29.92
|
-6.22 units on Scale
Standard Deviation 29.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C19D22
|
-4.58 units on Scale
Standard Deviation 20.32
|
-7.58 units on Scale
Standard Deviation 12.05
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C3D1
|
-8.42 units on Scale
Standard Deviation 30.85
|
-10.27 units on Scale
Standard Deviation 30.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C20D1
|
-2.54 units on Scale
Standard Deviation 24.67
|
1.11 units on Scale
Standard Deviation 12.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C4D22
|
-5.42 units on Scale
Standard Deviation 31.47
|
-11.46 units on Scale
Standard Deviation 29.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C5D1
|
-5.59 units on Scale
Standard Deviation 32.28
|
-8.97 units on Scale
Standard Deviation 34.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C5D22
|
-6.01 units on Scale
Standard Deviation 32.47
|
-7.47 units on Scale
Standard Deviation 30.16
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C6D1
|
-6.50 units on Scale
Standard Deviation 32.13
|
-8.47 units on Scale
Standard Deviation 31.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C9D1
|
-8.44 units on Scale
Standard Deviation 29.05
|
-13.98 units on Scale
Standard Deviation 25.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C12D22
|
3.95 units on Scale
Standard Deviation 19.25
|
4.33 units on Scale
Standard Deviation 18.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Global Health Status C22D22
|
-10.61 units on Scale
Standard Deviation 29.13
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C14D1
|
-9.40 units on Scale
Standard Deviation 25.30
|
-5.56 units on Scale
Standard Deviation 27.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C19D1
|
8.70 units on Scale
Standard Deviation 23.09
|
-2.22 units on Scale
Standard Deviation 19.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C15D22
|
-8.89 units on Scale
Standard Deviation 26.16
|
-3.92 units on Scale
Standard Deviation 26.04
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C19D1
|
-8.70 units on Scale
Standard Deviation 28.81
|
-2.22 units on Scale
Standard Deviation 29.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C21D22
|
-9.52 units on Scale
Standard Deviation 24.21
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C22D22
|
-3.03 units on Scale
Standard Deviation 27.71
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C23D1
|
-2.08 units on Scale
Standard Deviation 28.46
|
-2.56 units on Scale
Standard Deviation 25.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C23D22
|
-6.06 units on Scale
Standard Deviation 29.13
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C24D1
|
-7.14 units on Scale
Standard Deviation 26.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C25D22
|
-3.03 units on Scale
Standard Deviation 31.46
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C26D1
|
-7.69 units on Scale
Standard Deviation 27.74
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C27D1
|
-9.09 units on Scale
Standard Deviation 30.15
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia C28D1
|
-5.56 units on Scale
Standard Deviation 27.83
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia 30 Day Follow up
|
-2.31 units on Scale
Standard Deviation 28.71
|
-2.93 units on Scale
Standard Deviation 33.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Insomnia 90 Day Follow up
|
1.94 units on Scale
Standard Deviation 29.53
|
-3.21 units on Scale
Standard Deviation 39.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss Baseline
|
32.81 units on Scale
Standard Deviation 32.14
|
32.17 units on Scale
Standard Deviation 31.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C2D1
|
-4.99 units on Scale
Standard Deviation 36.01
|
-8.00 units on Scale
Standard Deviation 31.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C22D22
|
-2.27 units on Scale
Standard Deviation 27.41
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C23D1
|
7.81 units on Scale
Standard Deviation 19.36
|
5.13 units on Scale
Standard Deviation 21.93
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C23D22
|
4.55 units on Scale
Standard Deviation 17.62
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C4D1
|
-6.08 units on Scale
Standard Deviation 38.49
|
-7.36 units on Scale
Standard Deviation 34.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C25D22
|
1.52 units on Scale
Standard Deviation 22.92
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C26D1
|
10.90 units on Scale
Standard Deviation 24.86
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning C27D1
|
13.64 units on Scale
Standard Deviation 18.36
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Emotional Functioning 30 Day follow up
|
-2.55 units on Scale
Standard Deviation 22.19
|
-2.47 units on Scale
Standard Deviation 19.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C9D22
|
-13.33 units on Scale
Standard Deviation 41.26
|
-1.82 units on Scale
Standard Deviation 27.53
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C10D1
|
-10.10 units on Scale
Standard Deviation 38.33
|
-5.36 units on Scale
Standard Deviation 27.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C11D1
|
-15.34 units on Scale
Standard Deviation 36.82
|
-2.17 units on Scale
Standard Deviation 28.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C11D22
|
-12.12 units on Scale
Standard Deviation 33.79
|
-6.45 units on Scale
Standard Deviation 31.53
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C1D22
|
-3.01 units on Scale
Standard Deviation 18.04
|
-0.32 units on Scale
Standard Deviation 14.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C14D22
|
-6.25 units on Scale
Standard Deviation 39.20
|
-7.02 units on Scale
Standard Deviation 21.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C15D1
|
-6.67 units on Scale
Standard Deviation 39.44
|
-6.17 units on Scale
Standard Deviation 27.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C15D22
|
-5.56 units on Scale
Standard Deviation 42.96
|
-7.84 units on Scale
Standard Deviation 25.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C16D1
|
-14.29 units on Scale
Standard Deviation 27.16
|
-7.58 units on Scale
Standard Deviation 22.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C16D22
|
-6.90 units on Scale
Standard Deviation 39.22
|
-7.14 units on Scale
Standard Deviation 23.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C3D22
|
-3.07 units on Scale
Standard Deviation 18.83
|
-0.11 units on Scale
Standard Deviation 13.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C4D1
|
0.10 units on Scale
Standard Deviation 19.82
|
-1.64 units on Scale
Standard Deviation 15.85
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C25D1
|
-2.78 units on Scale
Standard Deviation 33.21
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C25D22
|
-3.03 units on Scale
Standard Deviation 27.71
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C26D1
|
-10.26 units on Scale
Standard Deviation 28.50
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C27D1
|
-3.03 units on Scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss C28D1
|
0.00 units on Scale
Standard Deviation 28.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Appetite Loss 30 Day Follow up
|
2.31 units on Scale
Standard Deviation 31.81
|
3.30 units on Scale
Standard Deviation 32.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation Baseline
|
19.33 units on Scale
Standard Deviation 28.15
|
19.64 units on Scale
Standard Deviation 28.39
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C14D22
|
-4.17 units on Scale
Standard Deviation 21.17
|
-3.51 units on Scale
Standard Deviation 24.58
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C16D22
|
-1.15 units on Scale
Standard Deviation 18.86
|
-1.19 units on Scale
Standard Deviation 17.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C22D22
|
4.55 units on Scale
Standard Deviation 19.85
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C23D22
|
1.52 units on Scale
Standard Deviation 15.73
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C24D1
|
2.38 units on Scale
Standard Deviation 18.32
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C25D1
|
4.17 units on Scale
Standard Deviation 14.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Cognitive Functioning C26D1
|
2.56 units on Scale
Standard Deviation 19.06
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C3D1
|
0.53 units on Scale
Standard Deviation 25.31
|
2.44 units on Scale
Standard Deviation 26.78
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C3D22
|
-5.70 units on Scale
Standard Deviation 25.09
|
3.80 units on Scale
Standard Deviation 25.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C4D22
|
-0.95 units on Scale
Standard Deviation 25.28
|
2.73 units on Scale
Standard Deviation 22.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C5D1
|
-1.57 units on Scale
Standard Deviation 29.21
|
1.38 units on Scale
Standard Deviation 29.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C5D22
|
-0.75 units on Scale
Standard Deviation 28.37
|
0.86 units on Scale
Standard Deviation 27.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C6D1
|
0.54 units on Scale
Standard Deviation 24.51
|
0.27 units on Scale
Standard Deviation 26.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C6D22
|
1.29 units on Scale
Standard Deviation 24.44
|
3.01 units on Scale
Standard Deviation 29.33
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C7D1
|
-1.61 units on Scale
Standard Deviation 24.49
|
0.00 units on Scale
Standard Deviation 24.87
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C7D22
|
-1.03 units on Scale
Standard Deviation 26.66
|
4.50 units on Scale
Standard Deviation 26.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C8D22
|
1.85 units on Scale
Standard Deviation 21.04
|
1.03 units on Scale
Standard Deviation 24.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C11D22
|
-0.76 units on Scale
Standard Deviation 21.55
|
-3.76 units on Scale
Standard Deviation 22.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C15D1
|
2.38 units on Scale
Standard Deviation 28.34
|
-6.17 units on Scale
Standard Deviation 24.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C16D1
|
3.33 units on Scale
Standard Deviation 22.43
|
3.79 units on Scale
Standard Deviation 24.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C16D22
|
1.15 units on Scale
Standard Deviation 22.24
|
3.57 units on Scale
Standard Deviation 26.29
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C18D1
|
1.85 units on Scale
Standard Deviation 21.85
|
-1.04 units on Scale
Standard Deviation 20.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C18D22
|
2.38 units on Scale
Standard Deviation 16.06
|
-6.67 units on Scale
Standard Deviation 11.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C19D1
|
3.62 units on Scale
Standard Deviation 16.63
|
-5.56 units on Scale
Standard Deviation 16.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C19D22
|
0.83 units on Scale
Standard Deviation 11.44
|
-4.55 units on Scale
Standard Deviation 16.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C20D1
|
2.17 units on Scale
Standard Deviation 19.66
|
-3.33 units on Scale
Standard Deviation 19.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C20D22
|
1.85 units on Scale
Standard Deviation 15.00
|
5.00 units on Scale
Standard Deviation 13.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C21D1
|
6.67 units on Scale
Standard Deviation 16.58
|
-11.90 units on Scale
Standard Deviation 15.23
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C21D22
|
7.14 units on Scale
Standard Deviation 15.63
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C22D1
|
1.11 units on Scale
Standard Deviation 20.38
|
-4.17 units on Scale
Standard Deviation 16.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C22D22
|
-4.55 units on Scale
Standard Deviation 21.20
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C23D1
|
1.04 units on Scale
Standard Deviation 17.71
|
-2.56 units on Scale
Standard Deviation 16.45
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C23D22
|
4.55 units on Scale
Standard Deviation 19.85
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C27D1
|
6.06 units on Scale
Standard Deviation 23.89
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning C28D1
|
5.56 units on Scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning 30 Day follow up
|
-12.73 units on Scale
Standard Deviation 30.45
|
-2.56 units on Scale
Standard Deviation 26.98
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Social Functioning 90 Day follow up
|
-9.88 units on Scale
Standard Deviation 29.64
|
-6.02 units on Scale
Standard Deviation 27.74
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue Baseline
|
31.13 units on Scale
Standard Deviation 23.94
|
32.69 units on Scale
Standard Deviation 23.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C1D22
|
8.47 units on Scale
Standard Deviation 23.12
|
4.50 units on Scale
Standard Deviation 20.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C2D1
|
3.81 units on Scale
Standard Deviation 22.20
|
-1.48 units on Scale
Standard Deviation 22.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C2D22
|
4.00 units on Scale
Standard Deviation 22.75
|
-0.06 units on Scale
Standard Deviation 21.90
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C3D1
|
2.11 units on Scale
Standard Deviation 23.61
|
-2.13 units on Scale
Standard Deviation 21.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C8D22
|
-0.77 units on Scale
Standard Deviation 22.71
|
-1.03 units on Scale
Standard Deviation 23.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C11D22
|
-3.79 units on Scale
Standard Deviation 19.31
|
-0.36 units on Scale
Standard Deviation 21.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C12D22
|
1.17 units on Scale
Standard Deviation 18.04
|
2.67 units on Scale
Standard Deviation 22.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C13D1
|
-1.16 units on Scale
Standard Deviation 21.77
|
3.17 units on Scale
Standard Deviation 23.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C14D22
|
0.00 units on Scale
Standard Deviation 21.49
|
-0.58 units on Scale
Standard Deviation 20.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C15D22
|
2.96 units on Scale
Standard Deviation 9.12
|
-7.19 units on Scale
Standard Deviation 21.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C16D1
|
-2.22 units on Scale
Standard Deviation 22.51
|
0.51 units on Scale
Standard Deviation 21.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C19D22
|
-1.11 units on Scale
Standard Deviation 19.71
|
3.03 units on Scale
Standard Deviation 26.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C21D1
|
-4.44 units on Scale
Standard Deviation 15.88
|
-0.79 units on Scale
Standard Deviation 19.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C21D22
|
8.73 units on Scale
Standard Deviation 21.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C23D22
|
7.07 units on Scale
Standard Deviation 18.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C24D1
|
6.35 units on Scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C25D1
|
6.48 units on Scale
Standard Deviation 15.32
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C25D22
|
8.08 units on Scale
Standard Deviation 20.54
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Fatigue C28D1
|
3.70 units on Scale
Standard Deviation 15.95
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C1D22
|
9.13 units on Scale
Standard Deviation 23.77
|
2.70 units on Scale
Standard Deviation 23.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C4D22
|
2.30 units on Scale
Standard Deviation 25.46
|
-3.39 units on 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 C5D1
|
-0.22 units on Scale
Standard Deviation 23.00
|
-6.78 units on Scale
Standard Deviation 23.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C6D1
|
-2.98 units on Scale
Standard Deviation 19.33
|
-3.42 units on Scale
Standard Deviation 24.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C7D1
|
-2.63 units on Scale
Standard Deviation 19.40
|
-4.25 units on Scale
Standard Deviation 21.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C8D1
|
-1.46 units on Scale
Standard Deviation 18.41
|
-3.61 units on Scale
Standard Deviation 16.68
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C9D1
|
-6.22 units on Scale
Standard Deviation 20.46
|
-4.57 units on Scale
Standard Deviation 23.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C10D22
|
-1.17 units on Scale
Standard Deviation 21.33
|
-2.71 units on Scale
Standard Deviation 25.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C14D22
|
-2.08 units on Scale
Standard Deviation 24.59
|
-7.02 units on Scale
Standard Deviation 24.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C15D22
|
-3.89 units on Scale
Standard Deviation 22.18
|
-2.94 units on Scale
Standard Deviation 31.31
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C16D1
|
-7.62 units on Scale
Standard Deviation 22.63
|
1.52 units on Scale
Standard Deviation 33.69
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C16D22
|
-1.72 units on Scale
Standard Deviation 29.33
|
-7.14 units on Scale
Standard Deviation 30.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C17D1
|
-10.00 units on Scale
Standard Deviation 21.71
|
-4.63 units on Scale
Standard Deviation 27.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C17D22
|
-1.45 units on Scale
Standard Deviation 21.85
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C20D22
|
-4.63 units on Scale
Standard Deviation 25.44
|
-8.33 units on Scale
Standard Deviation 32.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C21D1
|
-1.67 units on Scale
Standard Deviation 16.13
|
-3.57 units on Scale
Standard Deviation 30.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C23D1
|
-5.21 units on Scale
Standard Deviation 19.92
|
-3.85 units on Scale
Standard Deviation 30.55
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C23D22
|
-6.06 units on Scale
Standard Deviation 23.89
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C24D1
|
-8.33 units on Scale
Standard Deviation 21.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C25D1
|
-8.33 units on Scale
Standard Deviation 21.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C25D22
|
-6.06 units on Scale
Standard Deviation 25.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C26D1
|
-10.26 units on Scale
Standard Deviation 21.01
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C27D1
|
-1.52 units on Scale
Standard Deviation 8.99
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Nausea and Vomiting C28D1
|
-4.17 units on Scale
Standard Deviation 14.43
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain Baseline
|
25.68 units on Scale
Standard Deviation 25.51
|
26.61 units on Scale
Standard Deviation 25.13
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C2D1
|
-6.36 units on Scale
Standard Deviation 24.77
|
-9.19 units on Scale
Standard Deviation 21.93
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C5D22
|
-5.41 units on Scale
Standard Deviation 26.32
|
-5.60 units on Scale
Standard Deviation 24.27
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C7D1
|
-5.56 units on Scale
Standard Deviation 24.15
|
-6.80 units on Scale
Standard Deviation 20.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C7D22
|
-1.65 units on Scale
Standard Deviation 25.22
|
-6.98 units on Scale
Standard Deviation 20.65
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C8D1
|
-2.92 units on Scale
Standard Deviation 25.13
|
-7.83 units on Scale
Standard Deviation 18.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C11D22
|
-7.20 units on Scale
Standard Deviation 22.85
|
-3.23 units on Scale
Standard Deviation 15.17
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C12D1
|
-7.55 units on Scale
Standard Deviation 22.54
|
-1.22 units on Scale
Standard Deviation 19.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C13D22
|
-2.03 units on Scale
Standard Deviation 25.87
|
-7.14 units on Scale
Standard Deviation 21.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C14D1
|
-4.27 units on Scale
Standard Deviation 24.10
|
-1.11 units on Scale
Standard Deviation 19.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C15D1
|
-4.76 units on Scale
Standard Deviation 23.07
|
1.85 units on Scale
Standard Deviation 25.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Pain C15D22
|
-5.00 units on Scale
Standard Deviation 18.65
|
-4.90 units on Scale
Standard Deviation 28.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C5D1
|
-2.24 units on Scale
Standard Deviation 31.16
|
-1.15 units on Scale
Standard Deviation 30.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C5D22
|
2.70 units on Scale
Standard Deviation 31.83
|
-1.44 units on Scale
Standard Deviation 26.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C6D22
|
-3.24 units on Scale
Standard Deviation 27.82
|
-1.77 units on Scale
Standard Deviation 30.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C7D1
|
-2.63 units on Scale
Standard Deviation 29.80
|
-1.36 units on Scale
Standard Deviation 29.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C8D1
|
-4.17 units on Scale
Standard Deviation 27.75
|
-0.40 units on Scale
Standard Deviation 29.67
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C8D22
|
-6.94 units on Scale
Standard Deviation 29.04
|
-2.56 units on Scale
Standard Deviation 25.21
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C9D1
|
-8.44 units on Scale
Standard Deviation 26.90
|
0.00 units on Scale
Standard Deviation 28.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C9D22
|
-3.33 units on Scale
Standard Deviation 32.88
|
2.42 units on Scale
Standard Deviation 33.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C10D1
|
-2.02 units on Scale
Standard Deviation 29.74
|
4.17 units on Scale
Standard Deviation 30.53
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C10D22
|
-1.17 units on Scale
Standard Deviation 22.68
|
7.75 units on Scale
Standard Deviation 31.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C11D1
|
-4.23 units on Scale
Standard Deviation 24.31
|
7.25 units on Scale
Standard Deviation 31.36
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C11D22
|
-4.55 units on Scale
Standard Deviation 26.50
|
6.45 units on Scale
Standard Deviation 24.97
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C12D1
|
-6.29 units on Scale
Standard Deviation 22.70
|
10.57 units on Scale
Standard Deviation 32.86
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C12D22
|
1.75 units on Scale
Standard Deviation 29.96
|
18.67 units on Scale
Standard Deviation 34.80
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C13D1
|
-3.47 units on Scale
Standard Deviation 26.84
|
10.48 units on Scale
Standard Deviation 35.95
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C13D22
|
-3.25 units on Scale
Standard Deviation 28.68
|
11.11 units on Scale
Standard Deviation 39.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C14D1
|
-8.55 units on Scale
Standard Deviation 25.04
|
11.11 units on Scale
Standard Deviation 36.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C14D22
|
-3.12 units on Scale
Standard Deviation 30.95
|
3.51 units on Scale
Standard Deviation 33.14
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C15D1
|
-8.57 units on Scale
Standard Deviation 30.62
|
6.17 units on Scale
Standard Deviation 32.08
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C15D22
|
-6.67 units on Scale
Standard Deviation 25.37
|
3.92 units on Scale
Standard Deviation 35.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C16D1
|
-5.71 units on Scale
Standard Deviation 24.90
|
7.58 units on Scale
Standard Deviation 36.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C17D1
|
-5.56 units on Scale
Standard Deviation 27.80
|
1.85 units on Scale
Standard Deviation 29.09
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C17D22
|
-7.25 units on Scale
Standard Deviation 26.51
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C18D1
|
-8.64 units on Scale
Standard Deviation 23.74
|
10.42 units on Scale
Standard Deviation 33.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C18D22
|
-1.59 units on Scale
Standard Deviation 24.67
|
6.67 units on Scale
Standard Deviation 37.84
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C19D1
|
-2.90 units on Scale
Standard Deviation 28.27
|
15.56 units on Scale
Standard Deviation 37.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C19D22
|
-5.00 units on Scale
Standard Deviation 22.36
|
18.18 units on Scale
Standard Deviation 37.61
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C20D1
|
-2.90 units on Scale
Standard Deviation 24.44
|
11.11 units on Scale
Standard Deviation 34.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C20D22
|
-7.41 units on Scale
Standard Deviation 26.95
|
3.33 units on Scale
Standard Deviation 29.19
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C21D1
|
-3.33 units on Scale
Standard Deviation 26.27
|
14.29 units on Scale
Standard Deviation 33.88
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C21D22
|
0.00 units on Scale
Standard Deviation 29.24
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C22D1
|
-6.67 units on Scale
Standard Deviation 25.82
|
2.78 units on Scale
Standard Deviation 30.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C22D22
|
-6.06 units on Scale
Standard Deviation 29.13
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C23D1
|
-4.17 units on Scale
Standard Deviation 26.87
|
17.95 units on Scale
Standard Deviation 35.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C23D22
|
-3.03 units on Scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C24D1
|
-9.52 units on Scale
Standard Deviation 27.51
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C25D1
|
2.78 units on Scale
Standard Deviation 30.01
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C25D22
|
-3.03 units on Scale
Standard Deviation 31.46
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C26D1
|
-5.13 units on Scale
Standard Deviation 32.90
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C27D1
|
0.00 units on Scale
Standard Deviation 33.33
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation C28D1
|
-5.56 units on Scale
Standard Deviation 31.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation 30 Day Follow up
|
0.00 units on Scale
Standard Deviation 32.14
|
2.56 units on Scale
Standard Deviation 34.15
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Constipation 90 Day Follow up
|
-5.43 units on Scale
Standard Deviation 33.86
|
1.20 units on Scale
Standard Deviation 30.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea Baseline
|
7.91 units on Scale
Standard Deviation 17.25
|
10.59 units on Scale
Standard Deviation 19.94
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C1D22
|
4.90 units on Scale
Standard Deviation 23.05
|
2.86 units on Scale
Standard Deviation 24.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C2D1
|
6.28 units on Scale
Standard Deviation 26.03
|
2.96 units on Scale
Standard Deviation 22.52
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C3D1
|
2.11 units on Scale
Standard Deviation 22.39
|
1.18 units on Scale
Standard Deviation 24.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C4D1
|
-0.20 units on Scale
Standard Deviation 22.20
|
1.02 units on Scale
Standard Deviation 24.12
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C4D22
|
1.90 units on Scale
Standard Deviation 23.49
|
-0.78 units on Scale
Standard Deviation 24.91
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C5D1
|
3.58 units on Scale
Standard Deviation 24.55
|
-0.92 units on Scale
Standard Deviation 25.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C5D22
|
0.30 units on Scale
Standard Deviation 20.84
|
-4.31 units on Scale
Standard Deviation 22.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C6D22
|
-3.24 units on Scale
Standard Deviation 17.16
|
-1.77 units on Scale
Standard Deviation 23.63
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C7D1
|
-3.51 units on Scale
Standard Deviation 20.50
|
-2.04 units on Scale
Standard Deviation 24.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C7D22
|
0.41 units on Scale
Standard Deviation 22.04
|
-7.66 units on Scale
Standard Deviation 23.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C8D1
|
-2.08 units on Scale
Standard Deviation 20.78
|
-2.81 units on Scale
Standard Deviation 22.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C8D22
|
-5.09 units on Scale
Standard Deviation 22.14
|
-2.05 units on Scale
Standard Deviation 22.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C9D1
|
-2.22 units on Scale
Standard Deviation 26.47
|
-2.69 units on Scale
Standard Deviation 18.40
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C9D22
|
-5.00 units on Scale
Standard Deviation 20.19
|
-3.03 units on Scale
Standard Deviation 22.47
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C10D1
|
-5.05 units on Scale
Standard Deviation 24.97
|
-1.79 units on Scale
Standard Deviation 19.51
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C10D22
|
-2.92 units on Scale
Standard Deviation 24.62
|
-1.55 units on Scale
Standard Deviation 21.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C11D1
|
-4.76 units on Scale
Standard Deviation 26.00
|
0.72 units on Scale
Standard Deviation 22.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C11D22
|
-4.55 units on Scale
Standard Deviation 18.46
|
-2.15 units on Scale
Standard Deviation 24.24
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C12D1
|
0.00 units on Scale
Standard Deviation 23.57
|
-3.25 units on Scale
Standard Deviation 19.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C12D22
|
-1.75 units on Scale
Standard Deviation 20.43
|
-4.00 units on Scale
Standard Deviation 20.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C13D1
|
-3.47 units on Scale
Standard Deviation 30.93
|
2.86 units on Scale
Standard Deviation 27.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C13D22
|
-4.07 units on Scale
Standard Deviation 23.80
|
4.76 units on Scale
Standard Deviation 19.11
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C14D1
|
-1.71 units on Scale
Standard Deviation 22.88
|
4.44 units on Scale
Standard Deviation 29.99
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C14D22
|
-3.13 units on Scale
Standard Deviation 21.35
|
1.75 units on Scale
Standard Deviation 26.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C14D1
|
0.85 units on Scale
Standard Deviation 22.28
|
5.56 units on Scale
Standard Deviation 26.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C14D22
|
0.00 units on Scale
Standard Deviation 23.95
|
-5.26 units on Scale
Standard Deviation 27.81
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C15D1
|
-5.71 units on Scale
Standard Deviation 28.57
|
6.17 units on Scale
Standard Deviation 30.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C15D22
|
-5.56 units on Scale
Standard Deviation 26.38
|
-1.96 units on Scale
Standard Deviation 27.56
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C16D1
|
-1.90 units on Scale
Standard Deviation 24.18
|
1.52 units on Scale
Standard Deviation 26.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C16D22
|
-1.15 units on Scale
Standard Deviation 28.84
|
2.38 units on Scale
Standard Deviation 27.62
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C17D1
|
-1.11 units on Scale
Standard Deviation 25.50
|
1.85 units on Scale
Standard Deviation 24.18
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C15D1
|
-4.76 units on Scale
Standard Deviation 23.07
|
-3.70 units on Scale
Standard Deviation 21.35
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C16D1
|
-6.67 units on Scale
Standard Deviation 27.77
|
3.03 units on Scale
Standard Deviation 32.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C16D22
|
0.00 units on Scale
Standard Deviation 25.20
|
-4.76 units on Scale
Standard Deviation 17.82
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C17D1
|
-6.67 units on Scale
Standard Deviation 26.84
|
-3.70 units on Scale
Standard Deviation 19.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C18D1
|
-4.94 units on Scale
Standard Deviation 23.94
|
-2.08 units on Scale
Standard Deviation 25.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C18D22
|
4.76 units on Scale
Standard Deviation 33.81
|
0.00 units on Scale
Standard Deviation 15.71
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C20D1
|
-4.35 units on Scale
Standard Deviation 25.23
|
-2.22 units on Scale
Standard Deviation 23.46
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C20D22
|
-5.56 units on Scale
Standard Deviation 20.61
|
3.33 units on Scale
Standard Deviation 10.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C21D1
|
-5.00 units on Scale
Standard Deviation 24.84
|
7.14 units on Scale
Standard Deviation 19.30
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C21D22
|
-4.76 units on Scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C22D1
|
-8.89 units on Scale
Standard Deviation 23.46
|
-5.56 units on Scale
Standard Deviation 23.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C23D1
|
-8.33 units on Scale
Standard Deviation 22.77
|
-5.13 units on Scale
Standard Deviation 22.96
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C23D22
|
-6.06 units on Scale
Standard Deviation 25.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C24D1
|
-11.90 units on Scale
Standard Deviation 24.83
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C25D1
|
-16.67 units on Scale
Standard Deviation 26.59
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C25D22
|
-12.12 units on Scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C26D1
|
-15.38 units on Scale
Standard Deviation 25.88
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C27D1
|
-9.09 units on Scale
Standard Deviation 21.56
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea C28D1
|
-11.11 units on Scale
Standard Deviation 21.71
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea 30 Day Follow up
|
3.24 units on Scale
Standard Deviation 24.49
|
3.66 units on Scale
Standard Deviation 20.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Diarrhoea 90 Day Follow up
|
3.88 units on Scale
Standard Deviation 26.77
|
9.24 units on Scale
Standard Deviation 30.49
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties Baseline
|
19.58 units on Scale
Standard Deviation 28.89
|
18.86 units on Scale
Standard Deviation 27.38
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C1D22
|
0.38 units on Scale
Standard Deviation 24.62
|
-0.48 units on Scale
Standard Deviation 21.75
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C2D1
|
-1.45 units on Scale
Standard Deviation 21.86
|
-1.93 units on Scale
Standard Deviation 24.01
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C2D22
|
-0.67 units on Scale
Standard Deviation 20.96
|
-1.84 units on Scale
Standard Deviation 23.76
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C3D1
|
-0.88 units on Scale
Standard Deviation 22.86
|
-1.85 units on Scale
Standard Deviation 24.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C3D22
|
0.00 units on Scale
Standard Deviation 21.36
|
-1.12 units on Scale
Standard Deviation 22.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C4D1
|
-2.55 units on Scale
Standard Deviation 20.51
|
-3.07 units on Scale
Standard Deviation 22.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C4D22
|
-1.90 units on Scale
Standard Deviation 26.41
|
-0.78 units on Scale
Standard Deviation 20.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C5D1
|
0.67 units on Scale
Standard Deviation 27.25
|
-0.23 units on Scale
Standard Deviation 26.79
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C5D22
|
2.10 units on Scale
Standard Deviation 23.04
|
-1.72 units on Scale
Standard Deviation 26.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C6D1
|
-1.63 units on Scale
Standard Deviation 22.93
|
2.73 units on Scale
Standard Deviation 25.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C6D22
|
-2.27 units on Scale
Standard Deviation 21.52
|
0.00 units on Scale
Standard Deviation 26.32
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C7D1
|
-1.46 units on Scale
Standard Deviation 24.04
|
0.68 units on Scale
Standard Deviation 23.92
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C18D1
|
1.23 units on Scale
Standard Deviation 17.25
|
2.08 units on Scale
Standard Deviation 25.73
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C7D22
|
-1.65 units on Scale
Standard Deviation 22.91
|
-2.70 units on Scale
Standard Deviation 28.00
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C8D1
|
0.42 units on Scale
Standard Deviation 24.59
|
0.80 units on Scale
Standard Deviation 26.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C8D22
|
-1.39 units on Scale
Standard Deviation 24.67
|
1.54 units on Scale
Standard Deviation 27.28
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C9D1
|
-1.33 units on Scale
Standard Deviation 23.53
|
-1.08 units on Scale
Standard Deviation 27.64
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C9D22
|
-1.11 units on Scale
Standard Deviation 28.10
|
1.82 units on Scale
Standard Deviation 32.34
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C10D1
|
-1.01 units on Scale
Standard Deviation 26.13
|
4.76 units on Scale
Standard Deviation 31.42
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C10D22
|
-2.92 units on Scale
Standard Deviation 26.19
|
3.88 units on Scale
Standard Deviation 33.50
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C11D1
|
-3.17 units on Scale
Standard Deviation 28.53
|
0.72 units on Scale
Standard Deviation 31.02
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C11D22
|
-2.27 units on Scale
Standard Deviation 31.66
|
6.45 units on Scale
Standard Deviation 23.44
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C12D1
|
-1.26 units on Scale
Standard Deviation 30.64
|
5.69 units on Scale
Standard Deviation 23.45
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C13D1
|
-2.78 units on Scale
Standard Deviation 27.36
|
3.81 units on Scale
Standard Deviation 22.54
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C18D22
|
0.00 units on Scale
Standard Deviation 14.91
|
3.33 units on Scale
Standard Deviation 24.60
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C20D22
|
3.70 units on Scale
Standard Deviation 19.43
|
6.67 units on Scale
Standard Deviation 34.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C19D22
|
5.00 units on Scale
Standard Deviation 16.31
|
6.06 units on Scale
Standard Deviation 32.72
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C20D1
|
0.00 units on Scale
Standard Deviation 17.41
|
4.44 units on Scale
Standard Deviation 24.77
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C21D1
|
1.67 units on Scale
Standard Deviation 22.88
|
11.90 units on Scale
Standard Deviation 28.06
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C21D22
|
-7.14 units on Scale
Standard Deviation 19.30
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C22D1
|
-2.22 units on Scale
Standard Deviation 19.79
|
2.78 units on Scale
Standard Deviation 26.43
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C23D1
|
-2.08 units on Scale
Standard Deviation 19.12
|
0.00 units on Scale
Standard Deviation 23.57
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C23D22
|
-6.06 units on Scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C24D1
|
-4.76 units on Scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C25D1
|
-5.56 units on Scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C25D22
|
-6.06 units on Scale
Standard Deviation 25.03
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C26D1
|
-5.13 units on Scale
Standard Deviation 22.96
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C27D1
|
-3.03 units on Scale
Standard Deviation 23.35
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties C28D1
|
-2.78 units on Scale
Standard Deviation 22.29
|
—
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties 30 Day Follow up
|
4.17 units on Scale
Standard Deviation 26.79
|
5.13 units on Scale
Standard Deviation 26.26
|
|
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Financial Difficulties 90 Day Follow up
|
7.75 units on Scale
Standard Deviation 24.35
|
4.02 units on Scale
Standard Deviation 31.41
|
SECONDARY outcome
Timeframe: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow upPopulation: FAS with available data was analyzed.
The EORTC-QLQ-OG25 consists of a 25-item instrument that evaluates gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion. This module consists of 6 scales: dysphagia (3 items), eating restrictions (4 items), reflux (2 items), odynophagia (2 items), pain and discomfort (2 items) and anxiety (2 items), as well as 10 single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight loss and hair loss. All questions have four response alternatives (1:not at all; 2:a little, 3:quite a bit, 4:very much). Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 For symptom scales/items, higher scores indicate worse symptoms.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=257 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=257 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C12D22
|
-1.80 unit on a scale
Standard Deviation 17.47
|
-1.33 unit on a scale
Standard Deviation 15.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C13D1
|
-0.69 unit on a scale
Standard Deviation 16.11
|
0.95 unit on a scale
Standard Deviation 22.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C23D1
|
-4.44 unit on a scale
Standard Deviation 21.33
|
2.56 unit on a scale
Standard Deviation 16.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C23D22
|
-9.09 unit on a scale
Standard Deviation 21.56
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C5D22
|
1.21 unit on a scale
Standard Deviation 20.66
|
-3.48 unit on a scale
Standard Deviation 23.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C22D22
|
0.00 unit on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C23D22
|
-6.06 unit on a scale
Standard Deviation 13.48
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C2D1
|
0.81 unit on a scale
Standard Deviation 16.28
|
-0.75 unit on a scale
Standard Deviation 15.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C2D22
|
0.89 unit on a scale
Standard Deviation 16.81
|
0.93 unit on a scale
Standard Deviation 15.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C3D1
|
-0.18 unit on a scale
Standard Deviation 15.52
|
-0.34 unit on a scale
Standard Deviation 15.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C3D22
|
0.66 unit on a scale
Standard Deviation 16.93
|
0.23 unit on a scale
Standard Deviation 15.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C4D1
|
0.59 unit on a scale
Standard Deviation 16.05
|
-0.21 unit on a scale
Standard Deviation 14.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C4D22
|
2.19 unit on a scale
Standard Deviation 19.04
|
-0.52 unit on a scale
Standard Deviation 17.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C5D1
|
-0.68 unit on a scale
Standard Deviation 15.29
|
1.16 unit on a scale
Standard Deviation 17.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C5D22
|
1.21 unit on a scale
Standard Deviation 16.23
|
1.45 unit on a scale
Standard Deviation 19.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C7D22
|
-1.65 unit on a scale
Standard Deviation 15.72
|
0.46 unit on a scale
Standard Deviation 15.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C8D1
|
1.25 unit on a scale
Standard Deviation 20.16
|
5.35 unit on a scale
Standard Deviation 17.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C8D22
|
-1.41 unit on a scale
Standard Deviation 15.36
|
3.59 unit on a scale
Standard Deviation 18.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C9D1
|
-2.67 unit on a scale
Standard Deviation 11.96
|
3.23 unit on a scale
Standard Deviation 17.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C9D22
|
-0.56 unit on a scale
Standard Deviation 15.64
|
1.82 unit on a scale
Standard Deviation 13.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C10D1
|
-1.01 unit on a scale
Standard Deviation 13.03
|
2.38 unit on a scale
Standard Deviation 12.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C10D22
|
0.58 unit on a scale
Standard Deviation 13.35
|
4.65 unit on a scale
Standard Deviation 18.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C11D1
|
0.53 unit on a scale
Standard Deviation 14.03
|
4.35 unit on a scale
Standard Deviation 19.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C11D22
|
-3.03 unit on a scale
Standard Deviation 14.05
|
4.30 unit on a scale
Standard Deviation 22.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C12D1
|
-0.63 unit on a scale
Standard Deviation 13.85
|
2.44 unit on a scale
Standard Deviation 17.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C12D22
|
-2.70 unit on a scale
Standard Deviation 12.12
|
8.00 unit on a scale
Standard Deviation 24.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C13D1
|
-0.69 unit on a scale
Standard Deviation 14.57
|
4.76 unit on a scale
Standard Deviation 21.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C14D1
|
-0.85 unit on a scale
Standard Deviation 14.28
|
3.33 unit on a scale
Standard Deviation 13.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C14D22
|
-2.08 unit on a scale
Standard Deviation 11.79
|
1.75 unit on a scale
Standard Deviation 7.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C15D1
|
0.00 unit on a scale
Standard Deviation 14.00
|
1.23 unit on a scale
Standard Deviation 11.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C15D22
|
0.00 unit on a scale
Standard Deviation 12.60
|
-1.96 unit on a scale
Standard Deviation 8.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C16D22
|
-3.45 unit on a scale
Standard Deviation 13.64
|
0.00 unit on a scale
Standard Deviation 13.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C17D1
|
1.11 unit on a scale
Standard Deviation 13.79
|
0.00 unit on a scale
Standard Deviation 11.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C17D22
|
-4.35 unit on a scale
Standard Deviation 15.26
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C18D1
|
-2.47 unit on a scale
Standard Deviation 8.90
|
0.00 unit on a scale
Standard Deviation 12.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C18D22
|
0.00 unit on a scale
Standard Deviation 10.81
|
-3.33 unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C19D1
|
-1.45 unit on a scale
Standard Deviation 6.95
|
2.22 unit on a scale
Standard Deviation 15.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C19D22
|
0.00 unit on a scale
Standard Deviation 0.00
|
-3.03 unit on a scale
Standard Deviation 10.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C20D1
|
4.35 unit on a scale
Standard Deviation 23.15
|
0.00 unit on a scale
Standard Deviation 12.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble Talking C20D22
|
-1.85 unit on a scale
Standard Deviation 7.86
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C21D1
|
-1.67 unit on a scale
Standard Deviation 7.45
|
-2.38 unit on a scale
Standard Deviation 8.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C21D22
|
0.00 unit on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C22D1
|
-2.22 unit on a scale
Standard Deviation 15.26
|
0.00 unit on a scale
Standard Deviation 14.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C22D22
|
-3.33 unit on a scale
Standard Deviation 10.54
|
0.00 unit on a scale
Standard Deviation 13.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C23D1
|
0.00 unit on a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C25D1
|
-5.56 unit on a scale
Standard Deviation 12.97
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C25D22
|
3.03 unit on a scale
Standard Deviation 23.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C26D1
|
-2.56 unit on a scale
Standard Deviation 9.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C27D1
|
-3.03 unit on a scale
Standard Deviation 10.05
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C28D1
|
-2.78 unit on a scale
Standard Deviation 9.62
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking 30 day follow up
|
1.85 unit on a scale
Standard Deviation 21.59
|
2.59 unit on a scale
Standard Deviation 15.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss Baseline
|
29.70 unit on a scale
Standard Deviation 32.47
|
34.24 unit on a scale
Standard Deviation 31.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C1D22
|
0.95 unit on a scale
Standard Deviation 28.60
|
-2.72 unit on a scale
Standard Deviation 28.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C2D1
|
-0.65 unit on a scale
Standard Deviation 31.23
|
-7.92 unit on a scale
Standard Deviation 28.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C2D22
|
0.00 unit on a scale
Standard Deviation 30.41
|
-6.11 unit on a scale
Standard Deviation 30.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C3D1
|
-2.46 unit on a scale
Standard Deviation 31.14
|
-9.35 unit on a scale
Standard Deviation 30.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C3D22
|
-1.75 unit on a scale
Standard Deviation 31.59
|
-9.46 unit on a scale
Standard Deviation 29.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C4D1
|
-5.72 unit on a scale
Standard Deviation 29.32
|
-13.87 unit on a scale
Standard Deviation 29.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C5D1
|
-3.15 unit on a scale
Standard Deviation 35.49
|
-12.04 unit on a scale
Standard Deviation 28.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C5D22
|
-5.76 unit on a scale
Standard Deviation 33.44
|
-13.33 unit on a scale
Standard Deviation 32.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C6D1
|
-6.01 unit on a scale
Standard Deviation 31.79
|
-11.02 unit on a scale
Standard Deviation 30.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C6D22
|
-9.39 unit on a scale
Standard Deviation 34.11
|
-15.58 unit on a scale
Standard Deviation 30.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C7D1
|
-11.80 unit on a scale
Standard Deviation 31.79
|
-15.31 unit on a scale
Standard Deviation 28.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C7D22
|
-8.64 unit on a scale
Standard Deviation 34.47
|
-21.00 unit on a scale
Standard Deviation 31.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C8D1
|
-10.83 unit on a scale
Standard Deviation 31.28
|
-13.58 unit on a scale
Standard Deviation 27.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C8D22
|
-11.27 unit on a scale
Standard Deviation 33.78
|
-14.87 unit on a scale
Standard Deviation 27.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C9D1
|
-15.56 unit on a scale
Standard Deviation 32.11
|
-13.98 unit on a scale
Standard Deviation 25.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C9D22
|
-9.44 unit on a scale
Standard Deviation 34.77
|
-19.39 unit on a scale
Standard Deviation 28.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C10D1
|
-10.61 unit on a scale
Standard Deviation 33.67
|
-16.07 unit on a scale
Standard Deviation 31.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C10D22
|
-11.11 unit on a scale
Standard Deviation 30.43
|
-20.93 unit on a scale
Standard Deviation 30.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C11D1
|
-12.17 unit on a scale
Standard Deviation 34.03
|
-15.94 unit on a scale
Standard Deviation 32.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C11D22
|
-17.42 unit on a scale
Standard Deviation 29.19
|
-17.20 unit on a scale
Standard Deviation 29.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C12D1
|
-10.06 unit on a scale
Standard Deviation 33.71
|
-18.70 unit on a scale
Standard Deviation 28.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C12D22
|
-11.71 unit on a scale
Standard Deviation 27.46
|
-20.00 unit on a scale
Standard Deviation 30.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C13D1
|
-10.42 unit on a scale
Standard Deviation 29.30
|
-21.90 unit on a scale
Standard Deviation 33.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C13D22
|
-10.00 unit on a scale
Standard Deviation 26.37
|
-25.40 unit on a scale
Standard Deviation 23.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C14D1
|
-11.97 unit on a scale
Standard Deviation 25.92
|
-21.11 unit on a scale
Standard Deviation 29.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C14D22
|
-8.33 unit on a scale
Standard Deviation 28.08
|
-26.32 unit on a scale
Standard Deviation 30.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C15D1
|
-6.67 unit on a scale
Standard Deviation 26.57
|
-23.46 unit on a scale
Standard Deviation 34.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C15D22
|
-8.05 unit on a scale
Standard Deviation 26.21
|
-23.53 unit on a scale
Standard Deviation 38.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C16D1
|
-13.33 unit on a scale
Standard Deviation 23.15
|
-18.18 unit on a scale
Standard Deviation 38.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C16D22
|
-8.05 unit on a scale
Standard Deviation 30.41
|
-23.81 unit on a scale
Standard Deviation 27.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C17D1
|
-10.00 unit on a scale
Standard Deviation 26.48
|
-20.37 unit on a scale
Standard Deviation 30.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C17D22
|
-8.70 unit on a scale
Standard Deviation 25.06
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C18D1
|
-14.81 unit on a scale
Standard Deviation 23.27
|
-16.67 unit on a scale
Standard Deviation 32.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C18D22
|
-15.00 unit on a scale
Standard Deviation 25.31
|
-30.00 unit on a scale
Standard Deviation 29.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C19D1
|
-17.39 unit on a scale
Standard Deviation 22.18
|
-17.78 unit on a scale
Standard Deviation 33.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C19D22
|
-11.67 unit on a scale
Standard Deviation 29.17
|
-27.27 unit on a scale
Standard Deviation 32.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C20D1
|
-15.94 unit on a scale
Standard Deviation 24.35
|
-17.78 unit on a scale
Standard Deviation 27.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C20D22
|
-14.81 unit on a scale
Standard Deviation 26.13
|
-30.00 unit on a scale
Standard Deviation 33.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C21D1
|
-16.67 unit on a scale
Standard Deviation 25.36
|
-23.81 unit on a scale
Standard Deviation 30.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C22D1
|
-15.56 unit on a scale
Standard Deviation 27.79
|
-16.67 unit on a scale
Standard Deviation 36.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C22D22
|
-20.00 unit on a scale
Standard Deviation 28.11
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C23D1
|
-15.56 unit on a scale
Standard Deviation 24.77
|
-15.38 unit on a scale
Standard Deviation 37.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C24D1
|
-16.67 unit on a scale
Standard Deviation 28.50
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C25D1
|
-11.11 unit on a scale
Standard Deviation 25.95
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C25D22
|
-12.12 unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C26D1
|
-17.95 unit on a scale
Standard Deviation 22.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C27D1
|
-24.24 unit on a scale
Standard Deviation 15.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C28D1
|
-16.67 unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss 30 day follow up
|
3.24 unit on a scale
Standard Deviation 34.10
|
-9.63 unit on a scale
Standard Deviation 33.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight Loss 90 Day follow up
|
-2.71 unit on a scale
Standard Deviation 37.99
|
-6.91 unit on a scale
Standard Deviation 37.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss Baseline
|
15.62 unit on a scale
Standard Deviation 26.54
|
14.14 unit on a scale
Standard Deviation 29.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C1D22
|
11.11 unit on a scale
Standard Deviation 25.38
|
4.07 unit on a scale
Standard Deviation 29.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C2D1
|
0.88 unit on a scale
Standard Deviation 27.39
|
3.10 unit on a scale
Standard Deviation 28.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C2D22
|
4.04 unit on a scale
Standard Deviation 32.01
|
3.45 unit on a scale
Standard Deviation 24.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C3D1
|
8.82 unit on a scale
Standard Deviation 26.35
|
2.70 unit on a scale
Standard Deviation 30.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C4D1
|
9.68 unit on a scale
Standard Deviation 23.08
|
7.78 unit on a scale
Standard Deviation 34.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C4D22
|
11.54 unit on a scale
Standard Deviation 22.98
|
11.59 unit on a scale
Standard Deviation 21.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C5D1
|
6.17 unit on a scale
Standard Deviation 24.52
|
10.67 unit on a scale
Standard Deviation 26.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C5D22
|
10.53 unit on a scale
Standard Deviation 27.34
|
0.00 unit on a scale
Standard Deviation 37.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C6D1
|
8.70 unit on a scale
Standard Deviation 25.06
|
9.52 unit on a scale
Standard Deviation 28.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C6D22
|
4.17 unit on a scale
Standard Deviation 23.96
|
4.76 unit on a scale
Standard Deviation 38.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C7D1
|
2.22 unit on a scale
Standard Deviation 23.46
|
7.84 unit on a scale
Standard Deviation 30.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C7D22
|
1.96 unit on a scale
Standard Deviation 18.52
|
5.56 unit on a scale
Standard Deviation 37.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C8D1
|
5.56 unit on a scale
Standard Deviation 17.15
|
0.00 unit on a scale
Standard Deviation 30.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C9D1
|
0.00 unit on a scale
Standard Deviation 14.91
|
0.00 unit on a scale
Standard Deviation 36.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C9D22
|
13.33 unit on a scale
Standard Deviation 17.21
|
0.00 unit on a scale
Standard Deviation 40.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C10D1
|
11.11 unit on a scale
Standard Deviation 28.87
|
6.67 unit on a scale
Standard Deviation 40.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C10D22
|
12.50 unit on a scale
Standard Deviation 17.25
|
-9.52 unit on a scale
Standard Deviation 53.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C11D1
|
15.15 unit on a scale
Standard Deviation 17.41
|
0.00 unit on a scale
Standard Deviation 43.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C11D22
|
12.50 unit on a scale
Standard Deviation 17.25
|
4.76 unit on a scale
Standard Deviation 23.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C12D1
|
13.33 unit on a scale
Standard Deviation 23.31
|
-5.56 unit on a scale
Standard Deviation 49.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C12D22
|
12.50 unit on a scale
Standard Deviation 35.36
|
-16.67 unit on a scale
Standard Deviation 40.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C13D1
|
7.41 unit on a scale
Standard Deviation 14.70
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C13D22
|
13.33 unit on a scale
Standard Deviation 18.26
|
4.76 unit on a scale
Standard Deviation 29.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C14D1
|
9.52 unit on a scale
Standard Deviation 16.27
|
6.67 unit on a scale
Standard Deviation 27.89
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C15D1
|
23.81 unit on a scale
Standard Deviation 37.09
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C15D22
|
16.67 unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C16D1
|
13.33 unit on a scale
Standard Deviation 18.26
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C16D22
|
16.67 unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C17D1
|
8.33 unit on a scale
Standard Deviation 31.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C17D22
|
0.00 unit on a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C18D1
|
0.00 unit on a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C19D22
|
41.67 unit on a scale
Standard Deviation 31.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss 30 day follow up
|
-11.11 unit on a scale
Standard Deviation 45.54
|
18.18 unit on a scale
Standard Deviation 22.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss 90 day follow up
|
21.43 unit on a scale
Standard Deviation 33.61
|
16.67 unit on a scale
Standard Deviation 25.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C4D22
|
-2.82 unit on a scale
Standard Deviation 22.11
|
-7.26 unit on a scale
Standard Deviation 24.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C27D1
|
1.01 unit on a scale
Standard Deviation 12.62
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia 30 day follow-up
|
0.93 unit on a scale
Standard Deviation 21.65
|
-5.93 unit on a scale
Standard Deviation 28.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C17D1
|
-1.11 unit on a scale
Standard Deviation 21.86
|
1.85 unit on a scale
Standard Deviation 20.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C22D22
|
-6.67 unit on a scale
Standard Deviation 19.56
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C13D1
|
-3.82 unit on a scale
Standard Deviation 16.93
|
-3.33 unit on a scale
Standard Deviation 13.89
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C13D22
|
-4.17 unit on a scale
Standard Deviation 18.78
|
0.79 unit on a scale
Standard Deviation 15.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C14D1
|
-2.56 unit on a scale
Standard Deviation 23.43
|
-0.00 unit on a scale
Standard Deviation 13.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C6D1
|
-7.51 unit on a scale
Standard Deviation 23.77
|
-5.79 unit on a scale
Standard Deviation 23.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C16D1
|
-7.14 unit on a scale
Standard Deviation 25.34
|
-3.03 unit on a scale
Standard Deviation 20.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C12D22
|
-13.06 unit on a scale
Standard Deviation 28.64
|
-19.33 unit on a scale
Standard Deviation 29.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C13D1
|
-15.63 unit on a scale
Standard Deviation 29.26
|
-15.24 unit on a scale
Standard Deviation 25.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C13D22
|
-9.58 unit on a scale
Standard Deviation 25.84
|
-10.32 unit on a scale
Standard Deviation 26.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C14D1
|
-13.68 unit on a scale
Standard Deviation 25.33
|
-15.00 unit on a scale
Standard Deviation 24.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C15D1
|
-13.33 unit on a scale
Standard Deviation 27.65
|
-16.67 unit on a scale
Standard Deviation 30.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C15D22
|
-14.37 unit on a scale
Standard Deviation 27.72
|
-17.65 unit on a scale
Standard Deviation 33.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C16D1
|
-17.14 unit on a scale
Standard Deviation 31.95
|
-15.91 unit on a scale
Standard Deviation 29.76
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C16D22
|
-14.94 unit on a scale
Standard Deviation 26.48
|
-20.24 unit on a scale
Standard Deviation 31.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C17D1
|
-12.78 unit on a scale
Standard Deviation 33.53
|
-20.37 unit on a scale
Standard Deviation 29.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C17D22
|
-11.59 unit on a scale
Standard Deviation 22.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C18D1
|
-14.81 unit on a scale
Standard Deviation 27.48
|
-15.63 unit on a scale
Standard Deviation 25.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C24D1
|
-20.24 unit on a scale
Standard Deviation 35.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C4D1
|
-4.93 unit on a scale
Standard Deviation 27.13
|
-7.45 unit on a scale
Standard Deviation 23.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C21D22
|
-4.76 unit on a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C9D1
|
3.56 unit on a scale
Standard Deviation 20.92
|
12.37 unit on a scale
Standard Deviation 28.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C9D22
|
12.78 unit on a scale
Standard Deviation 28.85
|
11.52 unit on a scale
Standard Deviation 27.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C10D1
|
7.07 unit on a scale
Standard Deviation 23.76
|
8.33 unit on a scale
Standard Deviation 21.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C10D22
|
7.02 unit on a scale
Standard Deviation 22.48
|
9.30 unit on a scale
Standard Deviation 23.37
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C11D1
|
6.35 unit on a scale
Standard Deviation 26.00
|
7.25 unit on a scale
Standard Deviation 20.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C11D22
|
4.55 unit on a scale
Standard Deviation 18.46
|
8.60 unit on a scale
Standard Deviation 24.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C12D1
|
6.29 unit on a scale
Standard Deviation 26.20
|
8.13 unit on a scale
Standard Deviation 17.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C12D22
|
11.71 unit on a scale
Standard Deviation 25.11
|
16.00 unit on a scale
Standard Deviation 27.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C13D1
|
7.64 unit on a scale
Standard Deviation 20.90
|
10.48 unit on a scale
Standard Deviation 25.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C14D22
|
9.37 unit on a scale
Standard Deviation 22.77
|
12.28 unit on a scale
Standard Deviation 22.80
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C15D1
|
3.81 unit on a scale
Standard Deviation 26.53
|
6.17 unit on a scale
Standard Deviation 18.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C15D22
|
11.49 unit on a scale
Standard Deviation 28.56
|
3.92 unit on a scale
Standard Deviation 20.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C16D1
|
7.62 unit on a scale
Standard Deviation 21.52
|
4.55 unit on a scale
Standard Deviation 18.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C17D22
|
11.59 unit on a scale
Standard Deviation 29.49
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C18D1
|
1.23 unit on a scale
Standard Deviation 19.57
|
4.17 unit on a scale
Standard Deviation 20.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C19D1
|
2.90 unit on a scale
Standard Deviation 17.15
|
4.44 unit on a scale
Standard Deviation 17.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C19D22
|
5.00 unit on a scale
Standard Deviation 22.36
|
6.06 unit on a scale
Standard Deviation 25.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C20D1
|
1.45 unit on a scale
Standard Deviation 15.82
|
6.67 unit on a scale
Standard Deviation 22.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C20D22
|
3.70 unit on a scale
Standard Deviation 15.71
|
0.00 unit on a scale
Standard Deviation 15.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C21D1
|
6.67 unit on a scale
Standard Deviation 17.44
|
0.00 unit on a scale
Standard Deviation 13.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with Taste C21D22
|
-2.38 unit on a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C22D1
|
2.22 unit on a scale
Standard Deviation 15.26
|
5.56 unit on a scale
Standard Deviation 23.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C2D22
|
5.11 unit on a scale
Standard Deviation 26.96
|
2.78 unit on a scale
Standard Deviation 30.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C5D1
|
5.63 unit on a scale
Standard Deviation 28.67
|
-3.01 unit on a scale
Standard Deviation 26.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C7D22
|
3.70 unit on a scale
Standard Deviation 30.28
|
-5.48 unit on a scale
Standard Deviation 34.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C8D22
|
-0.47 unit on a scale
Standard Deviation 31.11
|
-6.15 unit on a scale
Standard Deviation 29.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C18D22
|
-5.00 unit on a scale
Standard Deviation 27.09
|
-20.00 unit on a scale
Standard Deviation 28.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C25D1
|
-8.33 unit on a scale
Standard Deviation 28.87
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C6D1
|
-0.82 unit on a scale
Standard Deviation 18.41
|
-0.55 unit on a scale
Standard Deviation 20.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C7D1
|
-1.77 unit on a scale
Standard Deviation 19.33
|
-1.70 unit on a scale
Standard Deviation 18.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C4D1
|
-0.99 unit on a scale
Standard Deviation 17.22
|
-1.86 unit on a scale
Standard Deviation 16.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C3D1
|
-0.18 unit on a scale
Standard Deviation 20.72
|
-2.89 unit on a scale
Standard Deviation 22.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C3D22
|
3.73 unit on a scale
Standard Deviation 25.02
|
-2.25 unit on a scale
Standard Deviation 21.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C17D1
|
-2.22 unit on a scale
Standard Deviation 17.36
|
-3.70 unit on a scale
Standard Deviation 10.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C17D22
|
-1.45 unit on a scale
Standard Deviation 21.27
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C18D1
|
-2.47 unit on a scale
Standard Deviation 18.32
|
0.00 unit on a scale
Standard Deviation 12.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C18D22
|
1.67 unit on a scale
Standard Deviation 13.13
|
0.00 unit on a scale
Standard Deviation 22.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C19D1
|
0.00 unit on a scale
Standard Deviation 17.41
|
-2.22 unit on a scale
Standard Deviation 15.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C19D22
|
0.00 unit on a scale
Standard Deviation 10.81
|
-3.03 unit on a scale
Standard Deviation 17.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C20D1
|
0.00 unit on a scale
Standard Deviation 10.05
|
-4.44 unit on a scale
Standard Deviation 11.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C20D22
|
0.00 unit on a scale
Standard Deviation 11.43
|
-3.33 unit on a scale
Standard Deviation 18.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C21D1
|
-1.67 unit on a scale
Standard Deviation 17.01
|
-4.76 unit on a scale
Standard Deviation 12.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C21D22
|
-4.76 unit on a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C22D1
|
-2.22 unit on a scale
Standard Deviation 15.26
|
-2.78 unit on a scale
Standard Deviation 17.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C22D22
|
-10.00 unit on a scale
Standard Deviation 22.50
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C24D1
|
-4.76 unit on a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C25D1
|
-8.33 unit on a scale
Standard Deviation 20.72
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C25D22
|
-6.06 unit on a scale
Standard Deviation 25.03
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C26D1
|
-5.13 unit on a scale
Standard Deviation 22.96
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C27D1
|
0.00 unit on a scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C28D1
|
0.00 unit on a scale
Standard Deviation 14.21
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing 30 Day follow up
|
1.39 unit on a scale
Standard Deviation 20.51
|
0.00 unit on a scale
Standard Deviation 17.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing 90 Day follow up
|
2.71 unit on a scale
Standard Deviation 19.28
|
1.63 unit on a scale
Standard Deviation 22.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing Baseline
|
12.06 unit on a scale
Standard Deviation 19.69
|
16.73 unit on a scale
Standard Deviation 22.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C1D22
|
4.17 unit on a scale
Standard Deviation 23.27
|
-3.04 unit on a scale
Standard Deviation 21.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C2D1
|
2.75 unit on a scale
Standard Deviation 23.47
|
-4.19 unit on a scale
Standard Deviation 24.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C2D22
|
2.22 unit on a scale
Standard Deviation 20.31
|
-3.70 unit on a scale
Standard Deviation 27.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C3D1
|
4.74 unit on a scale
Standard Deviation 26.24
|
-5.78 unit on a scale
Standard Deviation 24.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C3D22
|
3.29 unit on a scale
Standard Deviation 24.19
|
-4.28 unit on a scale
Standard Deviation 23.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C4D1
|
1.97 unit on a scale
Standard Deviation 23.77
|
-7.04 unit on a scale
Standard Deviation 23.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C4D22
|
1.37 unit on a scale
Standard Deviation 18.87
|
-4.20 unit on a scale
Standard Deviation 23.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C5D1
|
1.80 unit on a scale
Standard Deviation 20.86
|
-5.32 unit on a scale
Standard Deviation 22.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C6D1
|
-0.82 unit on a scale
Standard Deviation 22.05
|
-3.03 unit on a scale
Standard Deviation 22.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C6D22
|
-0.65 unit on a scale
Standard Deviation 19.79
|
-5.80 unit on a scale
Standard Deviation 22.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C7D1
|
0.29 unit on a scale
Standard Deviation 20.65
|
-4.42 unit on a scale
Standard Deviation 19.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C7D22
|
-1.65 unit on a scale
Standard Deviation 18.18
|
-7.31 unit on a scale
Standard Deviation 20.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C8D1
|
0.83 unit on a scale
Standard Deviation 21.85
|
-3.29 unit on a scale
Standard Deviation 20.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C8D22
|
2.35 unit on a scale
Standard Deviation 18.96
|
-5.64 unit on a scale
Standard Deviation 21.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C9D1
|
-2.22 unit on a scale
Standard Deviation 17.62
|
-1.61 unit on a scale
Standard Deviation 22.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C9D22
|
2.22 unit on a scale
Standard Deviation 22.01
|
-1.82 unit on a scale
Standard Deviation 22.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C10D1
|
-1.01 unit on a scale
Standard Deviation 18.46
|
-4.17 unit on a scale
Standard Deviation 22.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C10D22
|
0.58 unit on a scale
Standard Deviation 17.24
|
-3.88 unit on a scale
Standard Deviation 25.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C11D1
|
0.00 unit on a scale
Standard Deviation 17.96
|
-1.45 unit on a scale
Standard Deviation 26.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C11D22
|
-1.52 unit on a scale
Standard Deviation 16.00
|
0.00 unit on a scale
Standard Deviation 22.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C12D1
|
-0.63 unit on a scale
Standard Deviation 16.65
|
-4.88 unit on a scale
Standard Deviation 24.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C12D22
|
0.90 unit on a scale
Standard Deviation 12.39
|
-6.67 unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C13D1
|
2.08 unit on a scale
Standard Deviation 17.40
|
-8.57 unit on a scale
Standard Deviation 21.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C13D22
|
4.17 unit on a scale
Standard Deviation 15.45
|
-4.76 unit on a scale
Standard Deviation 28.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C14D1
|
2.56 unit on a scale
Standard Deviation 16.01
|
-2.22 unit on a scale
Standard Deviation 26.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C14D22
|
-3.12 unit on a scale
Standard Deviation 13.01
|
-7.02 unit on a scale
Standard Deviation 26.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C15D1
|
2.86 unit on a scale
Standard Deviation 23.39
|
-1.23 unit on a scale
Standard Deviation 25.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C15D22
|
0.00 unit on a scale
Standard Deviation 15.43
|
-7.84 unit on a scale
Standard Deviation 25.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C16D1
|
1.90 unit on a scale
Standard Deviation 16.05
|
-9.09 unit on a scale
Standard Deviation 21.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C16D22
|
4.60 unit on a scale
Standard Deviation 19.36
|
-9.52 unit on a scale
Standard Deviation 27.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C17D1
|
3.33 unit on a scale
Standard Deviation 16.02
|
-3.70 unit on a scale
Standard Deviation 25.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C17D22
|
-1.45 unit on a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C18D1
|
0.00 unit on a scale
Standard Deviation 16.01
|
-6.25 unit on a scale
Standard Deviation 27.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C18D22
|
1.67 unit on a scale
Standard Deviation 13.13
|
-10.00 unit on a scale
Standard Deviation 22.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C19D1
|
-1.45 unit on a scale
Standard Deviation 12.22
|
-4.44 unit on a scale
Standard Deviation 21.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C19D22
|
3.33 unit on a scale
Standard Deviation 14.91
|
-6.06 unit on a scale
Standard Deviation 25.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C20D1
|
0.00 unit on a scale
Standard Deviation 14.21
|
-4.44 unit on a scale
Standard Deviation 17.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C20D22
|
1.85 unit on a scale
Standard Deviation 13.87
|
-6.67 unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C21D1
|
-3.33 unit on a scale
Standard Deviation 10.26
|
0.00 unit on a scale
Standard Deviation 26.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C21D22
|
2.38 unit on a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C22D1
|
-4.44 unit on a scale
Standard Deviation 11.73
|
-2.78 unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C23D1
|
-2.22 unit on a scale
Standard Deviation 15.26
|
0.00 unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C24D1
|
-4.76 unit on a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C25D1
|
-8.33 unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C25D22
|
-3.03 unit on a scale
Standard Deviation 10.05
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C26D1
|
-7.69 unit on a scale
Standard Deviation 14.62
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C27D1
|
-6.06 unit on a scale
Standard Deviation 13.48
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing C28D1
|
-8.33 unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing 30 day follow up
|
-0.93 unit on a scale
Standard Deviation 27.96
|
-5.93 unit on a scale
Standard Deviation 26.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with coughing 90 Day follow up
|
2.33 unit on a scale
Standard Deviation 22.75
|
-2.85 unit on a scale
Standard Deviation 21.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking Baseline
|
5.45 unit on a scale
Standard Deviation 14.00
|
5.97 unit on a scale
Standard Deviation 15.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C1D22
|
3.03 unit on a scale
Standard Deviation 19.93
|
1.60 unit on a scale
Standard Deviation 14.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C6D1
|
-0.27 unit on a scale
Standard Deviation 15.74
|
1.10 unit on a scale
Standard Deviation 16.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C6D22
|
-1.62 unit on a scale
Standard Deviation 16.42
|
1.09 unit on a scale
Standard Deviation 16.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C7D1
|
-1.47 unit on a scale
Standard Deviation 17.47
|
0.34 unit on a scale
Standard Deviation 14.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C13D22
|
-0.83 unit on a scale
Standard Deviation 14.10
|
6.35 unit on a scale
Standard Deviation 22.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C16D1
|
-1.90 unit on a scale
Standard Deviation 13.87
|
1.52 unit on a scale
Standard Deviation 12.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C23D22
|
-3.03 unit on a scale
Standard Deviation 10.05
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking C24D1
|
-4.76 unit on a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C12D1
|
0.00 unit on a scale
Standard Deviation 16.01
|
-0.81 unit on a scale
Standard Deviation 13.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C21D22
|
-16.67 unit on a scale
Standard Deviation 28.50
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C23D22
|
-9.09 unit on a scale
Standard Deviation 30.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C13D22
|
0.83 unit on a scale
Standard Deviation 19.23
|
1.59 unit on a scale
Standard Deviation 16.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C14D1
|
-2.56 unit on a scale
Standard Deviation 16.01
|
0.00 unit on a scale
Standard Deviation 15.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C14D22
|
-6.25 unit on a scale
Standard Deviation 15.70
|
-1.75 unit on a scale
Standard Deviation 13.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C15D1
|
-0.95 unit on a scale
Standard Deviation 12.75
|
-2.47 unit on a scale
Standard Deviation 12.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C15D22
|
-4.60 unit on a scale
Standard Deviation 11.70
|
-3.92 unit on a scale
Standard Deviation 11.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C16D1
|
-1.90 unit on a scale
Standard Deviation 13.87
|
0.00 unit on a scale
Standard Deviation 10.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C16D22
|
-2.30 unit on a scale
Standard Deviation 12.38
|
-2.38 unit on a scale
Standard Deviation 8.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C3D22
|
10.34 unit on a scale
Standard Deviation 25.36
|
0.00 unit on a scale
Standard Deviation 27.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C8D22
|
9.09 unit on a scale
Standard Deviation 15.57
|
2.78 unit on a scale
Standard Deviation 26.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble talking 90 Day follow up
|
1.16 unit on a scale
Standard Deviation 18.75
|
4.88 unit on a scale
Standard Deviation 14.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Weight loss C4D22
|
-2.19 unit on a scale
Standard Deviation 32.84
|
-12.34 unit on a scale
Standard Deviation 29.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Hair loss C14D22
|
33.33 unit on a scale
Standard Deviation 40.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C4D1
|
-0.59 unit on a scale
Standard Deviation 21.66
|
-3.11 unit on a scale
Standard Deviation 21.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C7D1
|
-9.14 unit on a scale
Standard Deviation 26.63
|
-12.16 unit on a scale
Standard Deviation 24.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C7D22
|
-8.13 unit on a scale
Standard Deviation 28.41
|
-14.16 unit on a scale
Standard Deviation 25.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux Baseline
|
17.64 unit on a scale
Standard Deviation 24.43
|
16.60 unit on a scale
Standard Deviation 24.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C1D22
|
-1.70 unit on a scale
Standard Deviation 21.61
|
-1.28 unit on a scale
Standard Deviation 21.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C2D1
|
-2.99 unit on a scale
Standard Deviation 24.32
|
-5.31 unit on a scale
Standard Deviation 26.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C2D22
|
-4.56 unit on a scale
Standard Deviation 23.00
|
-5.00 unit on a scale
Standard Deviation 23.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C3D1
|
-5.61 unit on a scale
Standard Deviation 23.71
|
-6.46 unit on a scale
Standard Deviation 23.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C3D22
|
-4.39 unit on a scale
Standard Deviation 21.16
|
-5.86 unit on a scale
Standard Deviation 21.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C4D1
|
-5.52 unit on a scale
Standard Deviation 22.18
|
-5.28 unit on a scale
Standard Deviation 20.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C4D22
|
-2.46 unit on a scale
Standard Deviation 21.18
|
-5.64 unit on a scale
Standard Deviation 20.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C5D1
|
-4.95 unit on a scale
Standard Deviation 22.46
|
-3.24 unit on a scale
Standard Deviation 22.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C5D22
|
-2.88 unit on a scale
Standard Deviation 21.76
|
-2.75 unit on a scale
Standard Deviation 22.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C6D1
|
-5.87 unit on a scale
Standard Deviation 23.66
|
-1.38 unit on a scale
Standard Deviation 20.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C6D22
|
-4.53 unit on a scale
Standard Deviation 20.50
|
-1.81 unit on a scale
Standard Deviation 20.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C7D1
|
-4.13 unit on a scale
Standard Deviation 19.74
|
1.36 unit on a scale
Standard Deviation 18.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C7D22
|
-5.14 unit on a scale
Standard Deviation 21.99
|
-1.14 unit on a scale
Standard Deviation 16.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C8D1
|
-5.63 unit on a scale
Standard Deviation 21.37
|
0.41 unit on a scale
Standard Deviation 14.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C8D22
|
-6.34 unit on a scale
Standard Deviation 22.95
|
1.03 unit on a scale
Standard Deviation 18.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C9D1
|
-6.00 unit on a scale
Standard Deviation 23.19
|
-0.81 unit on a scale
Standard Deviation 16.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C9D22
|
-2.22 unit on a scale
Standard Deviation 18.27
|
1.82 unit on a scale
Standard Deviation 14.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C10D1
|
-4.80 unit on a scale
Standard Deviation 23.16
|
0.30 unit on a scale
Standard Deviation 17.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C10D22
|
-6.43 unit on a scale
Standard Deviation 20.11
|
5.04 unit on a scale
Standard Deviation 19.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C11D1
|
-7.41 unit on a scale
Standard Deviation 21.54
|
7.97 unit on a scale
Standard Deviation 24.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C11D22
|
-6.82 unit on a scale
Standard Deviation 17.36
|
7.53 unit on a scale
Standard Deviation 21.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C12D1
|
-4.40 unit on a scale
Standard Deviation 19.38
|
8.13 unit on a scale
Standard Deviation 24.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C12D22
|
-5.86 unit on a scale
Standard Deviation 21.95
|
2.67 unit on a scale
Standard Deviation 19.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C13D1
|
-4.17 unit on a scale
Standard Deviation 20.48
|
4.76 unit on a scale
Standard Deviation 21.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C13D22
|
-2.08 unit on a scale
Standard Deviation 18.94
|
5.56 unit on a scale
Standard Deviation 13.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C14D1
|
-1.71 unit on a scale
Standard Deviation 21.90
|
-0.56 unit on a scale
Standard Deviation 15.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C14D22
|
-5.73 unit on a scale
Standard Deviation 21.00
|
7.02 unit on a scale
Standard Deviation 13.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C15D1
|
-0.95 unit on a scale
Standard Deviation 14.54
|
2.47 unit on a scale
Standard Deviation 21.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C15D22
|
-4.60 unit on a scale
Standard Deviation 19.36
|
2.94 unit on a scale
Standard Deviation 15.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C16D1
|
-3.33 unit on a scale
Standard Deviation 17.99
|
6.06 unit on a scale
Standard Deviation 22.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C16D22
|
-8.62 unit on a scale
Standard Deviation 21.65
|
7.14 unit on a scale
Standard Deviation 28.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C17D22
|
-1.45 unit on a scale
Standard Deviation 21.27
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C18D1
|
-4.32 unit on a scale
Standard Deviation 20.46
|
-3.13 unit on a scale
Standard Deviation 17.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C18D22
|
0.83 unit on a scale
Standard Deviation 22.60
|
0.00 unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C19D1
|
-0.72 unit on a scale
Standard Deviation 15.47
|
-1.11 unit on a scale
Standard Deviation 20.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C19D22
|
-1.67 unit on a scale
Standard Deviation 14.20
|
3.03 unit on a scale
Standard Deviation 14.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia Baseline
|
18.50 unit on a scale
Standard Deviation 24.39
|
20.02 unit on a scale
Standard Deviation 26.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C8D1
|
-8.02 unit on a scale
Standard Deviation 21.72
|
-10.60 unit on a scale
Standard Deviation 23.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C8D22
|
-8.92 unit on a scale
Standard Deviation 23.41
|
-10.13 unit on a scale
Standard Deviation 26.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C9D1
|
-10.89 unit on a scale
Standard Deviation 24.12
|
-12.63 unit on a scale
Standard Deviation 24.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C1D22
|
2.90 unit on a scale
Standard Deviation 21.18
|
-1.66 unit on a scale
Standard Deviation 22.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C2D1
|
-3.83 unit on a scale
Standard Deviation 23.11
|
-7.92 unit on a scale
Standard Deviation 25.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C20D1
|
0.00 unit on a scale
Standard Deviation 15.08
|
-3.33 unit on a scale
Standard Deviation 14.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C20D22
|
-2.78 unit on a scale
Standard Deviation 15.39
|
1.67 unit on a scale
Standard Deviation 14.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C21D1
|
0.00 unit on a scale
Standard Deviation 9.37
|
-1.19 unit on a scale
Standard Deviation 12.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C21D22
|
0.00 unit on a scale
Standard Deviation 11.32
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C22D1
|
0.00 unit on a scale
Standard Deviation 19.92
|
-6.94 unit on a scale
Standard Deviation 16.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C2D22
|
-4.00 unit on a scale
Standard Deviation 22.34
|
-8.46 unit on a scale
Standard Deviation 23.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C3D1
|
-8.30 unit on a scale
Standard Deviation 23.64
|
-8.45 unit on a scale
Standard Deviation 24.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C3D22
|
-4.02 unit on a scale
Standard Deviation 23.60
|
-9.16 unit on a scale
Standard Deviation 26.55
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C9D22
|
-5.97 unit on a scale
Standard Deviation 26.80
|
-7.73 unit on a scale
Standard Deviation 25.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C10D1
|
-7.45 unit on a scale
Standard Deviation 25.20
|
-9.97 unit on a scale
Standard Deviation 25.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C10D22
|
-7.60 unit on a scale
Standard Deviation 25.11
|
-5.81 unit on a scale
Standard Deviation 29.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C11D1
|
-10.05 unit on a scale
Standard Deviation 24.05
|
-6.16 unit on a scale
Standard Deviation 28.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C11D22
|
-8.33 unit on a scale
Standard Deviation 23.23
|
-5.38 unit on a scale
Standard Deviation 20.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C12D1
|
-7.39 unit on a scale
Standard Deviation 21.10
|
-7.32 unit on a scale
Standard Deviation 24.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C12D22
|
-4.95 unit on a scale
Standard Deviation 20.64
|
-10.67 unit on a scale
Standard Deviation 20.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C23D1
|
-5.56 unit on a scale
Standard Deviation 15.00
|
0.00 unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C4D1
|
-6.64 unit on a scale
Standard Deviation 23.49
|
-8.70 unit on a scale
Standard Deviation 23.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C23D22
|
-6.06 unit on a scale
Standard Deviation 18.67
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C24D1
|
-4.76 unit on a scale
Standard Deviation 16.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C25D1
|
-5.56 unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C25D22
|
-4.55 unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C26D1
|
-1.28 unit on a scale
Standard Deviation 17.30
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C27D1
|
0.00 unit on a scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux C28D1
|
0.00 unit on a scale
Standard Deviation 12.31
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux 30 day follow up
|
-1.85 unit on a scale
Standard Deviation 26.32
|
-2.96 unit on a scale
Standard Deviation 26.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Reflux 90 day follow up
|
-0.78 unit on a scale
Standard Deviation 24.91
|
1.02 unit on a scale
Standard Deviation 26.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia Baseline
|
22.18 unit on a scale
Standard Deviation 25.96
|
22.44 unit on a scale
Standard Deviation 26.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C1D22
|
-2.37 unit on a scale
Standard Deviation 24.22
|
-5.69 unit on a scale
Standard Deviation 22.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C2D1
|
-4.77 unit on a scale
Standard Deviation 24.64
|
-9.19 unit on a scale
Standard Deviation 24.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C2D22
|
-6.22 unit on a scale
Standard Deviation 24.62
|
-9.35 unit on a scale
Standard Deviation 25.05
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C3D1
|
-9.39 unit on a scale
Standard Deviation 24.63
|
-11.39 unit on a scale
Standard Deviation 24.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C13D1
|
-7.47 unit on a scale
Standard Deviation 20.72
|
-9.52 unit on a scale
Standard Deviation 25.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C3D22
|
-6.36 unit on a scale
Standard Deviation 22.77
|
-12.50 unit on a scale
Standard Deviation 23.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C4D1
|
-9.66 unit on a scale
Standard Deviation 24.84
|
-11.18 unit on a scale
Standard Deviation 23.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C4D22
|
-3.69 unit on a scale
Standard Deviation 25.67
|
-9.19 unit on a scale
Standard Deviation 22.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C5D1
|
-4.73 unit on a scale
Standard Deviation 23.49
|
-11.23 unit on a scale
Standard Deviation 23.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C5D1
|
-6.31 unit on a scale
Standard Deviation 22.64
|
-8.02 unit on a scale
Standard Deviation 24.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C5D22
|
-4.85 unit on a scale
Standard Deviation 26.17
|
-11.01 unit on a scale
Standard Deviation 23.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C5D22
|
-4.85 unit on a scale
Standard Deviation 21.84
|
-7.25 unit on a scale
Standard Deviation 22.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C6D1
|
-5.37 unit on a scale
Standard Deviation 20.46
|
-5.42 unit on a scale
Standard Deviation 20.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C6D1
|
-7.92 unit on a scale
Standard Deviation 20.24
|
-8.13 unit on a scale
Standard Deviation 20.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C6D22
|
-5.07 unit on a scale
Standard Deviation 20.45
|
-7.61 unit on a scale
Standard Deviation 21.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C13D22
|
-4.17 unit on a scale
Standard Deviation 19.06
|
-7.94 unit on a scale
Standard Deviation 30.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C6D22
|
-8.41 unit on a scale
Standard Deviation 22.49
|
-12.32 unit on a scale
Standard Deviation 21.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C7D1
|
-9.44 unit on a scale
Standard Deviation 21.92
|
-7.99 unit on a scale
Standard Deviation 19.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C7D22
|
-8.23 unit on a scale
Standard Deviation 22.99
|
-7.31 unit on a scale
Standard Deviation 18.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C8D1
|
-5.21 unit on a scale
Standard Deviation 20.81
|
-6.58 unit on a scale
Standard Deviation 16.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C8D22
|
-8.69 unit on a scale
Standard Deviation 22.16
|
-7.44 unit on a scale
Standard Deviation 19.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C7D1
|
-6.88 unit on a scale
Standard Deviation 19.66
|
-6.35 unit on a scale
Standard Deviation 20.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C9D1
|
-8.67 unit on a scale
Standard Deviation 20.20
|
-8.06 unit on a scale
Standard Deviation 20.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C9D22
|
-5.56 unit on a scale
Standard Deviation 20.74
|
-2.42 unit on a scale
Standard Deviation 19.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C10D1
|
-6.31 unit on a scale
Standard Deviation 18.89
|
-4.17 unit on a scale
Standard Deviation 17.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C10D22
|
-4.09 unit on a scale
Standard Deviation 18.44
|
-3.49 unit on a scale
Standard Deviation 18.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C7D22
|
-6.04 unit on a scale
Standard Deviation 20.49
|
-8.07 unit on a scale
Standard Deviation 20.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C11D1
|
-5.56 unit on a scale
Standard Deviation 17.96
|
-2.54 unit on a scale
Standard Deviation 16.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C11D22
|
-3.41 unit on a scale
Standard Deviation 14.19
|
0.54 unit on a scale
Standard Deviation 11.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C12D1
|
-4.40 unit on a scale
Standard Deviation 20.45
|
-1.22 unit on a scale
Standard Deviation 15.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C12D22
|
-2.25 unit on a scale
Standard Deviation 17.64
|
-2.00 unit on a scale
Standard Deviation 17.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C14D22
|
-5.73 unit on a scale
Standard Deviation 15.03
|
-1.75 unit on a scale
Standard Deviation 15.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C8D1
|
-3.89 unit on a scale
Standard Deviation 18.38
|
-5.62 unit on a scale
Standard Deviation 16.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C8D22
|
-5.63 unit on a scale
Standard Deviation 17.90
|
-5.64 unit on a scale
Standard Deviation 20.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C15D1
|
-1.43 unit on a scale
Standard Deviation 15.85
|
2.47 unit on a scale
Standard Deviation 18.89
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C15D22
|
-1.72 unit on a scale
Standard Deviation 16.87
|
-1.96 unit on a scale
Standard Deviation 18.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C16D1
|
-3.81 unit on a scale
Standard Deviation 13.46
|
1.52 unit on a scale
Standard Deviation 18.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C16D22
|
-4.02 unit on a scale
Standard Deviation 15.21
|
1.19 unit on a scale
Standard Deviation 21.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C17D1
|
-4.44 unit on a scale
Standard Deviation 16.34
|
-0.93 unit on a scale
Standard Deviation 12.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C17D22
|
1.45 unit on a scale
Standard Deviation 25.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C18D1
|
-5.56 unit on a scale
Standard Deviation 16.67
|
-1.04 unit on a scale
Standard Deviation 14.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C18D22
|
-2.50 unit on a scale
Standard Deviation 13.55
|
-5.00 unit on a scale
Standard Deviation 13.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C19D1
|
-5.80 unit on a scale
Standard Deviation 13.86
|
-2.22 unit on a scale
Standard Deviation 12.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C19D22
|
-5.00 unit on a scale
Standard Deviation 13.36
|
-3.03 unit on a scale
Standard Deviation 17.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C20D1
|
-0.72 unit on a scale
Standard Deviation 25.37
|
-5.56 unit on a scale
Standard Deviation 16.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C20D22
|
-6.48 unit on a scale
Standard Deviation 14.16
|
0.00 unit on a scale
Standard Deviation 15.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C21D1
|
-3.33 unit on a scale
Standard Deviation 8.72
|
-3.57 unit on a scale
Standard Deviation 13.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C21D22
|
-1.19 unit on a scale
Standard Deviation 10.26
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C22D1
|
-2.22 unit on a scale
Standard Deviation 10.67
|
-2.78 unit on a scale
Standard Deviation 9.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C22D22
|
0.00 unit on a scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C23D1
|
-4.44 unit on a scale
Standard Deviation 9.89
|
-5.13 unit on a scale
Standard Deviation 8.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C23D22
|
0.00 unit on a scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C24D1
|
1.19 unit on a scale
Standard Deviation 21.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C25D1
|
-1.39 unit on a scale
Standard Deviation 4.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C25D22
|
4.55 unit on a scale
Standard Deviation 7.78
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C26D1
|
-1.28 unit on a scale
Standard Deviation 10.68
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C27D1
|
-4.55 unit on a scale
Standard Deviation 10.78
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia C28D1
|
1.39 unit on a scale
Standard Deviation 4.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia 30 day follow up
|
-3.01 unit on a scale
Standard Deviation 25.53
|
-4.44 unit on a scale
Standard Deviation 24.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Odynophagia 90 day follow up
|
-5.62 unit on a scale
Standard Deviation 27.49
|
-3.46 unit on a scale
Standard Deviation 29.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort Baseline
|
27.04 unit on a scale
Standard Deviation 26.61
|
26.39 unit on a scale
Standard Deviation 27.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C1D22
|
-4.55 unit on a scale
Standard Deviation 21.78
|
-3.45 unit on a scale
Standard Deviation 23.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C2D1
|
-4.94 unit on a scale
Standard Deviation 26.72
|
-8.37 unit on a scale
Standard Deviation 28.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C2D22
|
-8.00 unit on a scale
Standard Deviation 25.01
|
-8.89 unit on a scale
Standard Deviation 26.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C3D1
|
-9.56 unit on a scale
Standard Deviation 24.26
|
-8.50 unit on a scale
Standard Deviation 23.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C3D22
|
-6.14 unit on a scale
Standard Deviation 23.93
|
-8.67 unit on a scale
Standard Deviation 24.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C4D1
|
-9.76 unit on a scale
Standard Deviation 24.30
|
-8.70 unit on a scale
Standard Deviation 23.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C4D22
|
-6.56 unit on a scale
Standard Deviation 21.70
|
-8.79 unit on a scale
Standard Deviation 23.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C5D1
|
-5.29 unit on a scale
Standard Deviation 22.84
|
-8.68 unit on a scale
Standard Deviation 24.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C14D1
|
-6.84 unit on a scale
Standard Deviation 22.45
|
-8.61 unit on a scale
Standard Deviation 28.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C14D22
|
-7.29 unit on a scale
Standard Deviation 21.77
|
-8.33 unit on a scale
Standard Deviation 28.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C5D22
|
-7.42 unit on a scale
Standard Deviation 26.58
|
-8.99 unit on a scale
Standard Deviation 22.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C6D22
|
-9.87 unit on a scale
Standard Deviation 26.24
|
-12.68 unit on a scale
Standard Deviation 24.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C9D1
|
-6.67 unit on a scale
Standard Deviation 17.62
|
-6.81 unit on a scale
Standard Deviation 18.80
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C7D1
|
-8.41 unit on a scale
Standard Deviation 23.05
|
-8.50 unit on a scale
Standard Deviation 21.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C7D22
|
-9.67 unit on a scale
Standard Deviation 21.55
|
-8.68 unit on a scale
Standard Deviation 20.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C8D1
|
-5.42 unit on a scale
Standard Deviation 24.42
|
-7.82 unit on a scale
Standard Deviation 23.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C8D22
|
-10.09 unit on a scale
Standard Deviation 23.48
|
-9.23 unit on a scale
Standard Deviation 23.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C9D1
|
-10.00 unit on a scale
Standard Deviation 22.26
|
-7.53 unit on a scale
Standard Deviation 22.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C9D22
|
-6.94 unit on a scale
Standard Deviation 22.82
|
-7.27 unit on a scale
Standard Deviation 21.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C10D1
|
-10.35 unit on a scale
Standard Deviation 22.22
|
-7.14 unit on a scale
Standard Deviation 19.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C10D22
|
-6.14 unit on a scale
Standard Deviation 22.85
|
-3.49 unit on a scale
Standard Deviation 21.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C11D1
|
-8.47 unit on a scale
Standard Deviation 19.37
|
-0.72 unit on a scale
Standard Deviation 20.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C11D22
|
-7.95 unit on a scale
Standard Deviation 19.52
|
-2.15 unit on a scale
Standard Deviation 17.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C12D1
|
-4.40 unit on a scale
Standard Deviation 20.71
|
-1.63 unit on a scale
Standard Deviation 21.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C12D22
|
-4.95 unit on a scale
Standard Deviation 19.98
|
-1.33 unit on a scale
Standard Deviation 19.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C13D1
|
-4.86 unit on a scale
Standard Deviation 21.18
|
-2.38 unit on a scale
Standard Deviation 21.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C13D22
|
-4.58 unit on a scale
Standard Deviation 22.32
|
0.79 unit on a scale
Standard Deviation 23.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C14D1
|
-2.99 unit on a scale
Standard Deviation 22.58
|
-1.67 unit on a scale
Standard Deviation 21.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C14D22
|
-9.38 unit on a scale
Standard Deviation 17.42
|
-5.26 unit on a scale
Standard Deviation 20.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C15D1
|
-1.90 unit on a scale
Standard Deviation 24.51
|
-1.23 unit on a scale
Standard Deviation 24.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C15D22
|
-6.32 unit on a scale
Standard Deviation 24.16
|
-2.94 unit on a scale
Standard Deviation 25.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C16D22
|
-8.62 unit on a scale
Standard Deviation 22.55
|
-3.57 unit on a scale
Standard Deviation 23.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C17D1
|
-3.89 unit on a scale
Standard Deviation 22.61
|
1.85 unit on a scale
Standard Deviation 18.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C17D22
|
-4.35 unit on a scale
Standard Deviation 21.45
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C18D1
|
-8.02 unit on a scale
Standard Deviation 22.35
|
-4.17 unit on a scale
Standard Deviation 20.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C9D22
|
-5.93 unit on a scale
Standard Deviation 18.35
|
-3.03 unit on a scale
Standard Deviation 19.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C18D22
|
-8.33 unit on a scale
Standard Deviation 22.62
|
-6.67 unit on a scale
Standard Deviation 11.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C19D1
|
-13.77 unit on a scale
Standard Deviation 18.57
|
-6.67 unit on a scale
Standard Deviation 23.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C19D22
|
-7.50 unit on a scale
Standard Deviation 21.95
|
-4.55 unit on a scale
Standard Deviation 21.20
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C20D1
|
-11.59 unit on a scale
Standard Deviation 17.72
|
-7.78 unit on a scale
Standard Deviation 20.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C20D22
|
-11.11 unit on a scale
Standard Deviation 18.96
|
-5.00 unit on a scale
Standard Deviation 15.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C21D1
|
-8.33 unit on a scale
Standard Deviation 19.12
|
-10.71 unit on a scale
Standard Deviation 19.18
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C21D22
|
-9.52 unit on a scale
Standard Deviation 21.40
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C22D1
|
-13.33 unit on a scale
Standard Deviation 19.11
|
-4.17 unit on a scale
Standard Deviation 16.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C22D22
|
-13.33 unit on a scale
Standard Deviation 21.94
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C23D1
|
-14.44 unit on a scale
Standard Deviation 18.76
|
-7.69 unit on a scale
Standard Deviation 21.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C23D22
|
-10.61 unit on a scale
Standard Deviation 18.67
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C24D1
|
-13.10 unit on a scale
Standard Deviation 19.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C25D1
|
-11.11 unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C25D22
|
-10.61 unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C26D1
|
-14.10 unit on a scale
Standard Deviation 20.24
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C27D1
|
-10.61 unit on a scale
Standard Deviation 15.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort C28D1
|
-6.94 unit on a scale
Standard Deviation 16.60
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort 30 day follow up
|
-6.02 unit on a scale
Standard Deviation 29.11
|
-1.85 unit on a scale
Standard Deviation 27.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Pain and Discomfort 90 day follow up
|
-6.59 unit on a scale
Standard Deviation 30.17
|
-1.83 unit on a scale
Standard Deviation 32.50
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety Baseline
|
51.30 unit on a scale
Standard Deviation 28.99
|
52.92 unit on a scale
Standard Deviation 30.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C1D22
|
-8.33 unit on a scale
Standard Deviation 24.69
|
-6.09 unit on a scale
Standard Deviation 25.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C10D1
|
-5.56 unit on a scale
Standard Deviation 18.92
|
-4.76 unit on a scale
Standard Deviation 19.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C2D1
|
-10.19 unit on a scale
Standard Deviation 26.31
|
-11.29 unit on a scale
Standard Deviation 29.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C10D22
|
-8.38 unit on a scale
Standard Deviation 17.73
|
-3.10 unit on a scale
Standard Deviation 20.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C2D22
|
-11.67 unit on a scale
Standard Deviation 24.33
|
-11.85 unit on a scale
Standard Deviation 30.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C3D1
|
-12.63 unit on a scale
Standard Deviation 26.19
|
-13.44 unit on a scale
Standard Deviation 28.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C3D22
|
-9.65 unit on a scale
Standard Deviation 26.48
|
-14.30 unit on a scale
Standard Deviation 27.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C4D1
|
-14.60 unit on a scale
Standard Deviation 24.61
|
-12.63 unit on a scale
Standard Deviation 26.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C4D22
|
-11.34 unit on a scale
Standard Deviation 26.87
|
-12.99 unit on a scale
Standard Deviation 26.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C5D1
|
-12.16 unit on a scale
Standard Deviation 28.61
|
-7.75 unit on a scale
Standard Deviation 28.42
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C5D22
|
-10.30 unit on a scale
Standard Deviation 29.61
|
-8.12 unit on a scale
Standard Deviation 25.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C6D1
|
-13.39 unit on a scale
Standard Deviation 31.68
|
-9.09 unit on a scale
Standard Deviation 28.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C6D22
|
-11.65 unit on a scale
Standard Deviation 26.59
|
-14.67 unit on a scale
Standard Deviation 25.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C7D1
|
-12.68 unit on a scale
Standard Deviation 28.46
|
-17.18 unit on a scale
Standard Deviation 25.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C7D22
|
-13.79 unit on a scale
Standard Deviation 27.99
|
-15.98 unit on a scale
Standard Deviation 27.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C8D1
|
-11.46 unit on a scale
Standard Deviation 28.51
|
-14.20 unit on a scale
Standard Deviation 25.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C8D22
|
-13.62 unit on a scale
Standard Deviation 26.92
|
-16.92 unit on a scale
Standard Deviation 28.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C9D1
|
-18.22 unit on a scale
Standard Deviation 25.14
|
-15.86 unit on a scale
Standard Deviation 27.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C9D22
|
-16.94 unit on a scale
Standard Deviation 25.76
|
-20.30 unit on a scale
Standard Deviation 26.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C11D1
|
-6.53 unit on a scale
Standard Deviation 20.32
|
-0.24 unit on a scale
Standard Deviation 23.13
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C11D22
|
-8.59 unit on a scale
Standard Deviation 19.59
|
-1.08 unit on a scale
Standard Deviation 10.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C12D1
|
-4.19 unit on a scale
Standard Deviation 16.19
|
-4.34 unit on a scale
Standard Deviation 18.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C12D22
|
-6.61 unit on a scale
Standard Deviation 19.15
|
-5.33 unit on a scale
Standard Deviation 14.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C13D1
|
-6.25 unit on a scale
Standard Deviation 18.47
|
-4.76 unit on a scale
Standard Deviation 17.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C13D22
|
-4.72 unit on a scale
Standard Deviation 16.28
|
-6.88 unit on a scale
Standard Deviation 24.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C14D1
|
-4.27 unit on a scale
Standard Deviation 12.39
|
-5.56 unit on a scale
Standard Deviation 20.37
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C14D22
|
-4.17 unit on a scale
Standard Deviation 13.16
|
-7.02 unit on a scale
Standard Deviation 25.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C15D1
|
-2.22 unit on a scale
Standard Deviation 12.58
|
-5.76 unit on a scale
Standard Deviation 19.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C15D22
|
-4.98 unit on a scale
Standard Deviation 14.72
|
-6.54 unit on a scale
Standard Deviation 27.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C16D1
|
-4.44 unit on a scale
Standard Deviation 15.29
|
-4.55 unit on a scale
Standard Deviation 26.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C16D22
|
-2.30 unit on a scale
Standard Deviation 15.82
|
-8.73 unit on a scale
Standard Deviation 28.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C15D1
|
-1.90 unit on a scale
Standard Deviation 20.32
|
-6.17 unit on a scale
Standard Deviation 30.97
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C10D1
|
-16.67 unit on a scale
Standard Deviation 25.15
|
-18.15 unit on a scale
Standard Deviation 31.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C10D22
|
-18.71 unit on a scale
Standard Deviation 27.65
|
-13.95 unit on a scale
Standard Deviation 29.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C11D1
|
-18.25 unit on a scale
Standard Deviation 30.78
|
-9.06 unit on a scale
Standard Deviation 24.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C11D22
|
-20.83 unit on a scale
Standard Deviation 27.40
|
-14.52 unit on a scale
Standard Deviation 29.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C12D1
|
-17.30 unit on a scale
Standard Deviation 30.13
|
-10.57 unit on a scale
Standard Deviation 22.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C14D22
|
-18.75 unit on a scale
Standard Deviation 28.95
|
-10.53 unit on a scale
Standard Deviation 23.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C17D1
|
-2.22 unit on a scale
Standard Deviation 15.82
|
-6.79 unit on a scale
Standard Deviation 24.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C17D22
|
-4.35 unit on a scale
Standard Deviation 18.87
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C18D1
|
-5.76 unit on a scale
Standard Deviation 15.83
|
-7.64 unit on a scale
Standard Deviation 23.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C18D22
|
-6.11 unit on a scale
Standard Deviation 14.18
|
-6.67 unit on a scale
Standard Deviation 16.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C19D1
|
-3.38 unit on a scale
Standard Deviation 14.38
|
-2.22 unit on a scale
Standard Deviation 16.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C19D22
|
-3.89 unit on a scale
Standard Deviation 10.37
|
-4.04 unit on a scale
Standard Deviation 16.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C20D1
|
-4.35 unit on a scale
Standard Deviation 11.96
|
-3.70 unit on a scale
Standard Deviation 12.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C20D22
|
-6.17 unit on a scale
Standard Deviation 14.87
|
-5.56 unit on a scale
Standard Deviation 15.04
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C21D1
|
-3.89 unit on a scale
Standard Deviation 10.37
|
-4.76 unit on a scale
Standard Deviation 12.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C15D22
|
-5.17 unit on a scale
Standard Deviation 18.56
|
-12.75 unit on a scale
Standard Deviation 35.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C21D22
|
-4.76 unit on a scale
Standard Deviation 18.34
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C22D1
|
-3.70 unit on a scale
Standard Deviation 12.36
|
-5.56 unit on a scale
Standard Deviation 13.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C22D22
|
-2.22 unit on a scale
Standard Deviation 26.60
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C23D1
|
-4.44 unit on a scale
Standard Deviation 18.69
|
-4.27 unit on a scale
Standard Deviation 14.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C23D22
|
-7.07 unit on a scale
Standard Deviation 16.68
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C24D1
|
-3.17 unit on a scale
Standard Deviation 19.21
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C25D1
|
-4.63 unit on a scale
Standard Deviation 10.00
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C25D22
|
0.00 unit on a scale
Standard Deviation 12.17
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C26D1
|
-1.71 unit on a scale
Standard Deviation 14.23
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia C28D1
|
0.00 unit on a scale
Standard Deviation 12.54
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dysphagia 90 day follow-up
|
-2.20 unit on a scale
Standard Deviation 25.56
|
-5.42 unit on a scale
Standard Deviation 34.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C18D22
|
-15.83 unit on a scale
Standard Deviation 24.47
|
-16.67 unit on a scale
Standard Deviation 30.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions Baseline
|
30.54 unit on a scale
Standard Deviation 29.05
|
33.01 unit on a scale
Standard Deviation 30.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C1D22
|
4.40 unit on a scale
Standard Deviation 22.82
|
-1.32 unit on a scale
Standard Deviation 23.11
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C2D1
|
-3.32 unit on a scale
Standard Deviation 27.60
|
-9.94 unit on a scale
Standard Deviation 29.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C2D22
|
-5.00 unit on a scale
Standard Deviation 26.41
|
-7.92 unit on a scale
Standard Deviation 30.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C3D1
|
-8.77 unit on a scale
Standard Deviation 27.65
|
-13.52 unit on a scale
Standard Deviation 28.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C3D22
|
-0.38 unit on a scale
Standard Deviation 27.39
|
-10.98 unit on a scale
Standard Deviation 29.80
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C4D1
|
-6.41 unit on a scale
Standard Deviation 29.50
|
-13.15 unit on a scale
Standard Deviation 28.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C4D22
|
-1.09 unit on a scale
Standard Deviation 28.26
|
-10.96 unit on a scale
Standard Deviation 28.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C5D1
|
-4.84 unit on a scale
Standard Deviation 27.80
|
-13.43 unit on a scale
Standard Deviation 30.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C5D22
|
-3.86 unit on a scale
Standard Deviation 29.62
|
-11.09 unit on a scale
Standard Deviation 28.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C6D1
|
-7.79 unit on a scale
Standard Deviation 26.48
|
-9.92 unit on a scale
Standard Deviation 27.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C6D22
|
-8.25 unit on a scale
Standard Deviation 27.94
|
-14.67 unit on a scale
Standard Deviation 26.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C5D1
|
3.15 unit on a scale
Standard Deviation 32.14
|
1.16 unit on a scale
Standard Deviation 27.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C5D22
|
-1.91 unit on a scale
Standard Deviation 26.87
|
-0.58 unit on a scale
Standard Deviation 25.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C6D1
|
-0.87 unit on a scale
Standard Deviation 25.92
|
0.28 unit on a scale
Standard Deviation 29.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C6D22
|
-3.56 unit on a scale
Standard Deviation 27.97
|
-3.99 unit on a scale
Standard Deviation 25.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C7D1
|
-2.06 unit on a scale
Standard Deviation 25.31
|
-2.38 unit on a scale
Standard Deviation 29.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C16D1
|
-6.19 unit on a scale
Standard Deviation 18.89
|
-5.68 unit on a scale
Standard Deviation 36.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C16D22
|
-2.30 unit on a scale
Standard Deviation 26.72
|
-10.12 unit on a scale
Standard Deviation 37.15
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C17D1
|
-5.56 unit on a scale
Standard Deviation 16.86
|
-13.89 unit on a scale
Standard Deviation 30.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C17D22
|
-2.17 unit on a scale
Standard Deviation 17.63
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C18D1
|
-6.17 unit on a scale
Standard Deviation 17.54
|
-12.50 unit on a scale
Standard Deviation 31.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C18D22
|
-5.00 unit on a scale
Standard Deviation 15.86
|
-15.00 unit on a scale
Standard Deviation 23.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C19D1
|
-5.80 unit on a scale
Standard Deviation 13.63
|
-8.89 unit on a scale
Standard Deviation 26.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C19D22
|
-3.33 unit on a scale
Standard Deviation 15.63
|
-7.58 unit on a scale
Standard Deviation 20.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C20D1
|
-2.17 unit on a scale
Standard Deviation 21.35
|
-10.00 unit on a scale
Standard Deviation 21.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C20D22
|
-4.63 unit on a scale
Standard Deviation 17.90
|
-10.00 unit on a scale
Standard Deviation 19.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C21D1
|
-0.83 unit on a scale
Standard Deviation 15.74
|
-11.31 unit on a scale
Standard Deviation 20.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C21D22
|
-3.57 unit on a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C22D1
|
-5.00 unit on a scale
Standard Deviation 12.52
|
-9.72 unit on a scale
Standard Deviation 25.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C19D1
|
-19.57 unit on a scale
Standard Deviation 30.42
|
-21.11 unit on a scale
Standard Deviation 32.41
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C22D22
|
-2.50 unit on a scale
Standard Deviation 18.02
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C23D1
|
-6.11 unit on a scale
Standard Deviation 11.12
|
-8.97 unit on a scale
Standard Deviation 24.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C23D22
|
-4.55 unit on a scale
Standard Deviation 14.12
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C24D1
|
0.00 unit on a scale
Standard Deviation 19.88
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C25D1
|
-4.86 unit on a scale
Standard Deviation 13.51
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C25D22
|
-0.76 unit on a scale
Standard Deviation 13.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C26D1
|
-4.49 unit on a scale
Standard Deviation 11.59
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C27D1
|
-6.06 unit on a scale
Standard Deviation 10.60
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions C28D1
|
-4.17 unit on a scale
Standard Deviation 14.86
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions 30 day follow up
|
2.31 unit on a scale
Standard Deviation 25.03
|
-5.46 unit on a scale
Standard Deviation 33.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating restrictions 90 day follow up
|
-5.62 unit on a scale
Standard Deviation 30.80
|
-5.08 unit on a scale
Standard Deviation 38.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C7D22
|
-0.82 unit on a scale
Standard Deviation 29.33
|
-3.65 unit on a scale
Standard Deviation 31.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C8D1
|
-0.83 unit on a scale
Standard Deviation 28.05
|
-3.29 unit on a scale
Standard Deviation 29.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C8D22
|
-0.94 unit on a scale
Standard Deviation 28.16
|
0.51 unit on a scale
Standard Deviation 30.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C19D22
|
-10.00 unit on a scale
Standard Deviation 30.78
|
-16.67 unit on a scale
Standard Deviation 29.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C9D1
|
-0.44 unit on a scale
Standard Deviation 27.67
|
-0.54 unit on a scale
Standard Deviation 30.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C9D22
|
2.22 unit on a scale
Standard Deviation 29.98
|
-1.21 unit on a scale
Standard Deviation 31.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C10D1
|
-0.51 unit on a scale
Standard Deviation 30.66
|
-2.38 unit on a scale
Standard Deviation 28.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C20D1
|
-21.01 unit on a scale
Standard Deviation 28.52
|
-21.11 unit on a scale
Standard Deviation 26.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C20D22
|
-16.67 unit on a scale
Standard Deviation 25.57
|
-18.33 unit on a scale
Standard Deviation 22.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C21D1
|
-19.17 unit on a scale
Standard Deviation 29.75
|
-15.48 unit on a scale
Standard Deviation 33.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C21D22
|
-14.29 unit on a scale
Standard Deviation 21.54
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C22D1
|
-18.89 unit on a scale
Standard Deviation 33.25
|
-16.67 unit on a scale
Standard Deviation 26.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C22D22
|
-3.33 unit on a scale
Standard Deviation 42.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C23D1
|
-22.22 unit on a scale
Standard Deviation 38.14
|
-23.08 unit on a scale
Standard Deviation 29.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C23D22
|
-16.67 unit on a scale
Standard Deviation 29.81
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C25D1
|
-19.44 unit on a scale
Standard Deviation 38.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C25D22
|
-12.12 unit on a scale
Standard Deviation 38.07
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C26D1
|
-21.79 unit on a scale
Standard Deviation 36.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C27D1
|
-30.30 unit on a scale
Standard Deviation 30.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety C28D1
|
-20.83 unit on a scale
Standard Deviation 33.43
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety 30 day follow up
|
-3.47 unit on a scale
Standard Deviation 30.25
|
-6.30 unit on a scale
Standard Deviation 33.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Anxiety 90 day follow up
|
-2.52 unit on a scale
Standard Deviation 31.88
|
-2.44 unit on a scale
Standard Deviation 33.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others Baseline
|
14.66 unit on a scale
Standard Deviation 25.11
|
15.95 unit on a scale
Standard Deviation 26.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C1D22
|
-1.14 unit on a scale
Standard Deviation 25.42
|
-0.64 unit on a scale
Standard Deviation 23.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C2D1
|
-1.46 unit on a scale
Standard Deviation 25.57
|
-4.04 unit on a scale
Standard Deviation 23.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C10D22
|
-0.58 unit on a scale
Standard Deviation 25.58
|
-0.78 unit on a scale
Standard Deviation 31.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C11D1
|
1.59 unit on a scale
Standard Deviation 27.06
|
-2.17 unit on a scale
Standard Deviation 27.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C11D22
|
2.27 unit on a scale
Standard Deviation 24.27
|
-1.08 unit on a scale
Standard Deviation 21.92
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C12D1
|
2.52 unit on a scale
Standard Deviation 29.12
|
-0.81 unit on a scale
Standard Deviation 29.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C12D22
|
0.90 unit on a scale
Standard Deviation 25.44
|
2.67 unit on a scale
Standard Deviation 27.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C13D1
|
2.08 unit on a scale
Standard Deviation 26.10
|
-1.90 unit on a scale
Standard Deviation 29.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C13D22
|
4.17 unit on a scale
Standard Deviation 25.25
|
-1.59 unit on a scale
Standard Deviation 34.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C14D1
|
0.00 unit on a scale
Standard Deviation 26.49
|
-4.44 unit on a scale
Standard Deviation 29.99
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C14D22
|
0.00 unit on a scale
Standard Deviation 26.77
|
-5.26 unit on a scale
Standard Deviation 31.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C15D1
|
0.00 unit on a scale
Standard Deviation 29.15
|
-9.88 unit on a scale
Standard Deviation 28.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C15D22
|
0.00 unit on a scale
Standard Deviation 26.73
|
-13.73 unit on a scale
Standard Deviation 33.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C16D1
|
-1.90 unit on a scale
Standard Deviation 27.94
|
-12.12 unit on a scale
Standard Deviation 30.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C16D22
|
2.30 unit on a scale
Standard Deviation 26.62
|
-7.14 unit on a scale
Standard Deviation 41.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C17D1
|
5.56 unit on a scale
Standard Deviation 30.43
|
-9.26 unit on a scale
Standard Deviation 31.94
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C17D22
|
1.45 unit on a scale
Standard Deviation 27.48
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C18D1
|
-3.70 unit on a scale
Standard Deviation 23.27
|
-8.33 unit on a scale
Standard Deviation 35.49
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C18D22
|
-1.67 unit on a scale
Standard Deviation 22.88
|
-6.67 unit on a scale
Standard Deviation 30.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C19D1
|
-2.90 unit on a scale
Standard Deviation 26.43
|
-2.22 unit on a scale
Standard Deviation 23.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C19D22
|
-3.33 unit on a scale
Standard Deviation 18.42
|
0.00 unit on a scale
Standard Deviation 29.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C20D1
|
-5.80 unit on a scale
Standard Deviation 25.92
|
-4.44 unit on a scale
Standard Deviation 24.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C20D22
|
-5.56 unit on a scale
Standard Deviation 23.57
|
-6.67 unit on a scale
Standard Deviation 30.63
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C21D1
|
-10.00 unit on a scale
Standard Deviation 24.42
|
-2.38 unit on a scale
Standard Deviation 27.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C21D22
|
-4.76 unit on a scale
Standard Deviation 22.10
|
-11.11 unit on a scale
Standard Deviation 21.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C22D1
|
-11.11 unit on a scale
Standard Deviation 24.12
|
-2.56 unit on a scale
Standard Deviation 28.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C22D22
|
-10.00 unit on a scale
Standard Deviation 22.50
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C23D1
|
-13.33 unit on a scale
Standard Deviation 27.60
|
-2.56 unit on a scale
Standard Deviation 28.74
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C23D22
|
-12.12 unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C24D1
|
-14.29 unit on a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C25D1
|
-11.11 unit on a scale
Standard Deviation 21.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C25D22
|
-12.12 unit on a scale
Standard Deviation 22.47
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C26D1
|
-17.95 unit on a scale
Standard Deviation 25.88
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C27D1
|
-21.21 unit on a scale
Standard Deviation 26.97
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C28D1
|
-19.44 unit on a scale
Standard Deviation 26.43
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth 30 day follow up
|
5.09 unit on a scale
Standard Deviation 28.89
|
5.19 unit on a scale
Standard Deviation 36.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth 90 Day follow up
|
1.94 unit on a scale
Standard Deviation 30.83
|
4.47 unit on a scale
Standard Deviation 33.85
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste Baseline
|
12.06 unit on a scale
Standard Deviation 23.32
|
11.54 unit on a scale
Standard Deviation 22.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C1D22
|
10.80 unit on a scale
Standard Deviation 29.66
|
8.17 unit on a scale
Standard Deviation 27.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C2D1
|
12.62 unit on a scale
Standard Deviation 29.49
|
4.19 unit on a scale
Standard Deviation 28.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C2D22
|
15.78 unit on a scale
Standard Deviation 33.60
|
10.56 unit on a scale
Standard Deviation 31.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C3D1
|
14.56 unit on a scale
Standard Deviation 34.52
|
9.35 unit on a scale
Standard Deviation 30.53
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C3D22
|
21.93 unit on a scale
Standard Deviation 31.66
|
13.51 unit on a scale
Standard Deviation 31.31
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C4D1
|
17.75 unit on a scale
Standard Deviation 35.46
|
15.94 unit on a scale
Standard Deviation 34.78
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C4D22
|
20.49 unit on a scale
Standard Deviation 32.48
|
16.01 unit on a scale
Standard Deviation 35.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C5D1
|
19.59 unit on a scale
Standard Deviation 31.81
|
15.05 unit on a scale
Standard Deviation 29.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C5D22
|
20.00 unit on a scale
Standard Deviation 28.98
|
16.52 unit on a scale
Standard Deviation 30.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C6D1
|
12.02 unit on a scale
Standard Deviation 27.46
|
15.70 unit on a scale
Standard Deviation 26.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C6D22
|
9.71 unit on a scale
Standard Deviation 29.38
|
10.87 unit on a scale
Standard Deviation 28.86
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C7D1
|
8.55 unit on a scale
Standard Deviation 24.71
|
9.18 unit on a scale
Standard Deviation 23.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C7D22
|
10.70 unit on a scale
Standard Deviation 26.78
|
10.50 unit on a scale
Standard Deviation 24.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C8D1
|
6.25 unit on a scale
Standard Deviation 22.56
|
10.70 unit on a scale
Standard Deviation 22.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C8D22
|
3.76 unit on a scale
Standard Deviation 22.22
|
11.28 unit on a scale
Standard Deviation 22.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C13D22
|
10.00 unit on a scale
Standard Deviation 27.43
|
22.22 unit on a scale
Standard Deviation 30.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C14D1
|
4.27 unit on a scale
Standard Deviation 24.40
|
14.44 unit on a scale
Standard Deviation 27.24
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C16D22
|
6.90 unit on a scale
Standard Deviation 24.20
|
4.76 unit on a scale
Standard Deviation 22.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C17D1
|
4.44 unit on a scale
Standard Deviation 24.34
|
5.56 unit on a scale
Standard Deviation 20.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C18D22
|
3.33 unit on a scale
Standard Deviation 18.42
|
6.67 unit on a scale
Standard Deviation 26.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C22D22
|
0.00 unit on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C23D1
|
2.22 unit on a scale
Standard Deviation 15.26
|
5.13 unit on a scale
Standard Deviation 22.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C23D22
|
6.06 unit on a scale
Standard Deviation 13.48
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C24D1
|
2.38 unit on a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C25D1
|
0.00 unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C25D22
|
3.03 unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C26D1
|
2.56 unit on a scale
Standard Deviation 16.45
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C27D1
|
0.00 unit on a scale
Standard Deviation 14.91
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste C28D1
|
2.78 unit on a scale
Standard Deviation 22.29
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste 30 day follow up
|
12.96 unit on a scale
Standard Deviation 27.15
|
15.93 unit on a scale
Standard Deviation 32.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble with taste 90 day follow up
|
14.73 unit on a scale
Standard Deviation 28.29
|
13.82 unit on a scale
Standard Deviation 32.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image Baseline
|
22.57 unit on a scale
Standard Deviation 29.62
|
24.90 unit on a scale
Standard Deviation 30.80
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C1D22
|
3.60 unit on a scale
Standard Deviation 25.06
|
-0.96 unit on a scale
Standard Deviation 26.60
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C2D1
|
3.56 unit on a scale
Standard Deviation 26.91
|
0.00 unit on a scale
Standard Deviation 31.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C3D1
|
4.21 unit on a scale
Standard Deviation 25.54
|
-0.51 unit on a scale
Standard Deviation 29.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C3D22
|
7.46 unit on a scale
Standard Deviation 25.21
|
-0.90 unit on a scale
Standard Deviation 28.02
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C4D1
|
1.58 unit on a scale
Standard Deviation 24.07
|
-4.35 unit on a scale
Standard Deviation 28.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C4D22
|
9.29 unit on a scale
Standard Deviation 27.53
|
-3.41 unit on a scale
Standard Deviation 26.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C5D22
|
5.76 unit on a scale
Standard Deviation 30.91
|
-2.32 unit on a scale
Standard Deviation 34.69
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C6D1
|
4.64 unit on a scale
Standard Deviation 31.00
|
-1.93 unit on a scale
Standard Deviation 28.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C6D22
|
1.62 unit on a scale
Standard Deviation 27.76
|
-4.71 unit on a scale
Standard Deviation 29.06
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C7D1
|
-0.29 unit on a scale
Standard Deviation 29.04
|
-2.72 unit on a scale
Standard Deviation 31.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C8D1
|
-1.25 unit on a scale
Standard Deviation 28.29
|
-2.88 unit on a scale
Standard Deviation 30.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C9D1
|
-4.44 unit on a scale
Standard Deviation 30.67
|
-8.06 unit on a scale
Standard Deviation 32.33
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C9D22
|
-1.11 unit on a scale
Standard Deviation 32.46
|
-8.48 unit on a scale
Standard Deviation 32.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C10D1
|
-1.01 unit on a scale
Standard Deviation 32.54
|
-4.17 unit on a scale
Standard Deviation 33.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C10D22
|
-0.58 unit on a scale
Standard Deviation 31.80
|
-10.08 unit on a scale
Standard Deviation 31.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C11D1
|
-2.65 unit on a scale
Standard Deviation 31.28
|
-5.07 unit on a scale
Standard Deviation 31.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C11D22
|
-7.58 unit on a scale
Standard Deviation 27.72
|
-7.53 unit on a scale
Standard Deviation 33.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C12D1
|
-0.63 unit on a scale
Standard Deviation 28.86
|
-7.32 unit on a scale
Standard Deviation 30.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C12D22
|
0.00 unit on a scale
Standard Deviation 33.33
|
-4.00 unit on a scale
Standard Deviation 26.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C13D1
|
-2.08 unit on a scale
Standard Deviation 31.81
|
-5.71 unit on a scale
Standard Deviation 27.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C13D22
|
-5.00 unit on a scale
Standard Deviation 28.79
|
-12.70 unit on a scale
Standard Deviation 32.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C14D1
|
-4.27 unit on a scale
Standard Deviation 30.76
|
-11.11 unit on a scale
Standard Deviation 33.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C14D22
|
-1.04 unit on a scale
Standard Deviation 31.09
|
-12.28 unit on a scale
Standard Deviation 33.72
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C15D1
|
-3.81 unit on a scale
Standard Deviation 27.74
|
-12.35 unit on a scale
Standard Deviation 33.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C15D22
|
29.08 unit on a scale
Standard Deviation 8.05
|
-17.65 unit on a scale
Standard Deviation 33.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C16D1
|
-5.71 unit on a scale
Standard Deviation 28.57
|
-10.61 unit on a scale
Standard Deviation 37.64
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C16D22
|
-8.05 unit on a scale
Standard Deviation 26.21
|
-14.29 unit on a scale
Standard Deviation 33.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C17D1
|
0.00 unit on a scale
Standard Deviation 36.09
|
-7.41 unit on a scale
Standard Deviation 26.95
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C17D22
|
-2.90 unit on a scale
Standard Deviation 30.01
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C18D1
|
-7.41 unit on a scale
Standard Deviation 21.35
|
-4.17 unit on a scale
Standard Deviation 31.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C19D1
|
-1.45 unit on a scale
Standard Deviation 25.58
|
-4.44 unit on a scale
Standard Deviation 30.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C19D22
|
-5.00 unit on a scale
Standard Deviation 24.84
|
-12.12 unit on a scale
Standard Deviation 34.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C20D1
|
-2.90 unit on a scale
Standard Deviation 28.27
|
-8.89 unit on a scale
Standard Deviation 29.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C20D22
|
-3.70 unit on a scale
Standard Deviation 27.75
|
-16.67 unit on a scale
Standard Deviation 32.39
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C21D1
|
-6.67 unit on a scale
Standard Deviation 17.44
|
2.38 unit on a scale
Standard Deviation 40.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C21D22
|
-4.76 unit on a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C22D1
|
0.00 unit on a scale
Standard Deviation 28.17
|
-13.89 unit on a scale
Standard Deviation 36.12
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C22D22
|
-6.67 unit on a scale
Standard Deviation 30.63
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C23D1
|
-6.67 unit on a scale
Standard Deviation 22.54
|
-5.13 unit on a scale
Standard Deviation 35.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C23D22
|
-6.06 unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C24D1
|
-4.76 unit on a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C25D22
|
-9.09 unit on a scale
Standard Deviation 30.15
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C26D1
|
-5.13 unit on a scale
Standard Deviation 26.69
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C27D1
|
-12.12 unit on a scale
Standard Deviation 16.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image C28D1
|
-11.11 unit on a scale
Standard Deviation 16.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image 30 day follow up
|
9.72 unit on a scale
Standard Deviation 28.77
|
5.56 unit on a scale
Standard Deviation 31.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Body Image 90 Day follow up
|
6.98 unit on a scale
Standard Deviation 32.39
|
8.94 unit on a scale
Standard Deviation 29.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva Baseline
|
7.65 unit on a scale
Standard Deviation 17.36
|
9.08 unit on a scale
Standard Deviation 20.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C1D22
|
0.95 unit on a scale
Standard Deviation 21.51
|
-2.40 unit on a scale
Standard Deviation 19.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C2D1
|
1.46 unit on a scale
Standard Deviation 21.91
|
-3.44 unit on a scale
Standard Deviation 24.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C2D22
|
1.56 unit on a scale
Standard Deviation 19.44
|
-2.41 unit on a scale
Standard Deviation 24.16
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C4D22
|
1.64 unit on a scale
Standard Deviation 23.41
|
0.26 unit on a scale
Standard Deviation 21.62
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C5D1
|
3.60 unit on a scale
Standard Deviation 24.01
|
-2.78 unit on a scale
Standard Deviation 19.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C5D22
|
2.12 unit on a scale
Standard Deviation 21.31
|
-1.45 unit on a scale
Standard Deviation 21.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C2D22
|
-2.00 unit on a scale
Standard Deviation 28.96
|
-3.52 unit on a scale
Standard Deviation 25.28
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C3D1
|
-5.79 unit on a scale
Standard Deviation 25.11
|
-5.27 unit on a scale
Standard Deviation 27.23
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C6D22
|
-1.29 unit on a scale
Standard Deviation 18.03
|
-1.45 unit on a scale
Standard Deviation 20.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C7D22
|
-0.41 unit on a scale
Standard Deviation 20.75
|
-0.91 unit on a scale
Standard Deviation 20.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C3D22
|
-2.19 unit on a scale
Standard Deviation 26.21
|
-6.08 unit on a scale
Standard Deviation 26.38
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C8D1
|
0.00 unit on a scale
Standard Deviation 19.12
|
-2.47 unit on a scale
Standard Deviation 18.09
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C8D22
|
-0.47 unit on a scale
Standard Deviation 17.36
|
-3.59 unit on a scale
Standard Deviation 22.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C4D22
|
-0.82 unit on a scale
Standard Deviation 25.16
|
-4.99 unit on a scale
Standard Deviation 26.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C9D1
|
-0.44 unit on a scale
Standard Deviation 17.75
|
-2.15 unit on a scale
Standard Deviation 19.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C9D22
|
0.56 unit on a scale
Standard Deviation 19.88
|
-2.42 unit on a scale
Standard Deviation 20.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C10D1
|
-1.52 unit on a scale
Standard Deviation 21.43
|
-2.38 unit on a scale
Standard Deviation 19.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C10D22
|
-1.17 unit on a scale
Standard Deviation 20.86
|
-0.78 unit on a scale
Standard Deviation 21.19
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C11D1
|
0.00 unit on a scale
Standard Deviation 19.86
|
1.45 unit on a scale
Standard Deviation 23.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C11D22
|
-4.55 unit on a scale
Standard Deviation 21.07
|
4.30 unit on a scale
Standard Deviation 11.36
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C5D1
|
-3.83 unit on a scale
Standard Deviation 25.94
|
-4.63 unit on a scale
Standard Deviation 25.43
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C12D1
|
0.00 unit on a scale
Standard Deviation 14.62
|
0.00 unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C12D22
|
-3.60 unit on a scale
Standard Deviation 21.92
|
2.67 unit on a scale
Standard Deviation 16.44
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C13D1
|
-1.39 unit on a scale
Standard Deviation 22.76
|
0.00 unit on a scale
Standard Deviation 22.87
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C13D22
|
0.00 unit on a scale
Standard Deviation 23.87
|
0.00 unit on a scale
Standard Deviation 25.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C5D22
|
-2.42 unit on a scale
Standard Deviation 26.22
|
-4.06 unit on a scale
Standard Deviation 22.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C14D1
|
1.71 unit on a scale
Standard Deviation 17.01
|
-3.33 unit on a scale
Standard Deviation 20.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C14D22
|
-2.08 unit on a scale
Standard Deviation 14.51
|
-3.51 unit on a scale
Standard Deviation 24.58
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C15D1
|
-0.95 unit on a scale
Standard Deviation 15.09
|
-6.17 unit on a scale
Standard Deviation 20.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C6D1
|
-5.74 unit on a scale
Standard Deviation 22.14
|
-1.93 unit on a scale
Standard Deviation 24.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C15D22
|
-2.30 unit on a scale
Standard Deviation 12.38
|
-5.88 unit on a scale
Standard Deviation 24.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C16D1
|
0.95 unit on a scale
Standard Deviation 15.09
|
-3.03 unit on a scale
Standard Deviation 22.79
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C6D22
|
-2.27 unit on a scale
Standard Deviation 21.52
|
-4.71 unit on a scale
Standard Deviation 23.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C7D1
|
-2.36 unit on a scale
Standard Deviation 26.99
|
-4.76 unit on a scale
Standard Deviation 23.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C7D22
|
-2.88 unit on a scale
Standard Deviation 20.55
|
-3.65 unit on a scale
Standard Deviation 22.61
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C16D22
|
-1.15 unit on a scale
Standard Deviation 14.04
|
-7.14 unit on a scale
Standard Deviation 26.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C17D1
|
1.11 unit on a scale
Standard Deviation 16.34
|
-5.56 unit on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C17D22
|
0.00 unit on a scale
Standard Deviation 17.41
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C18D1
|
-1.23 unit on a scale
Standard Deviation 17.25
|
-6.25 unit on a scale
Standard Deviation 25.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C18D22
|
-1.67 unit on a scale
Standard Deviation 13.13
|
3.33 unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C19D1
|
-1.45 unit on a scale
Standard Deviation 12.22
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C19D22
|
0.00 unit on a scale
Standard Deviation 10.81
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C20D1
|
0.00 unit on a scale
Standard Deviation 10.05
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C20D22
|
0.00 unit on a scale
Standard Deviation 11.43
|
3.33 unit on a scale
Standard Deviation 10.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C21D1
|
1.67 unit on a scale
Standard Deviation 13.13
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C21D22
|
0.00 unit on a scale
Standard Deviation 13.07
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C22D1
|
-4.44 unit on a scale
Standard Deviation 17.21
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C22D22
|
-6.67 unit on a scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C23D1
|
-4.44 unit on a scale
Standard Deviation 17.21
|
0.00 unit on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C23D22
|
-9.09 unit on a scale
Standard Deviation 15.57
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C24D1
|
-2.38 unit on a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C25D1
|
-8.33 unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C25D22
|
-3.03 unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C26D1
|
-2.56 unit on a scale
Standard Deviation 21.35
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C27D1
|
-3.03 unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva C28D1
|
-2.78 unit on a scale
Standard Deviation 17.16
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva 30 Day follow up
|
6.94 unit on a scale
Standard Deviation 24.35
|
-0.37 unit on a scale
Standard Deviation 24.73
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Trouble swallowing saliva 90 Day follow up
|
2.33 unit on a scale
Standard Deviation 24.94
|
-1.63 unit on a scale
Standard Deviation 24.51
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing Baseline
|
7.00 unit on a scale
Standard Deviation 18.24
|
6.10 unit on a scale
Standard Deviation 15.65
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C1D22
|
1.52 unit on a scale
Standard Deviation 17.75
|
-1.28 unit on a scale
Standard Deviation 16.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C2D1
|
-0.49 unit on a scale
Standard Deviation 17.26
|
-1.05 unit on a scale
Standard Deviation 13.93
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C2D22
|
-2.67 unit on a scale
Standard Deviation 19.12
|
-1.30 unit on a scale
Standard Deviation 16.29
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C3D1
|
-1.23 unit on a scale
Standard Deviation 18.90
|
-0.34 unit on a scale
Standard Deviation 15.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C3D22
|
2.19 unit on a scale
Standard Deviation 19.81
|
-2.93 unit on a scale
Standard Deviation 16.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C4D22
|
1.09 unit on a scale
Standard Deviation 18.15
|
-0.26 unit on a scale
Standard Deviation 17.57
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C5D1
|
0.45 unit on a scale
Standard Deviation 18.64
|
-2.08 unit on a scale
Standard Deviation 15.88
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C5D22
|
0.91 unit on a scale
Standard Deviation 18.87
|
0.29 unit on a scale
Standard Deviation 18.47
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C6D1
|
-1.37 unit on a scale
Standard Deviation 17.87
|
0.83 unit on a scale
Standard Deviation 17.98
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C6D22
|
-1.62 unit on a scale
Standard Deviation 16.42
|
-2.90 unit on a scale
Standard Deviation 14.54
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C7D1
|
-2.95 unit on a scale
Standard Deviation 17.00
|
-2.04 unit on a scale
Standard Deviation 15.00
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C7D22
|
0.41 unit on a scale
Standard Deviation 17.07
|
-1.37 unit on a scale
Standard Deviation 16.14
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C8D1
|
-0.83 unit on a scale
Standard Deviation 18.35
|
0.00 unit on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C8D22
|
-1.88 unit on a scale
Standard Deviation 16.80
|
-0.51 unit on a scale
Standard Deviation 15.01
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C9D1
|
-2.22 unit on a scale
Standard Deviation 14.84
|
-1.61 unit on a scale
Standard Deviation 16.45
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C9D22
|
-0.56 unit on a scale
Standard Deviation 17.88
|
-0.61 unit on a scale
Standard Deviation 17.56
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C10D1
|
-0.51 unit on a scale
Standard Deviation 17.04
|
-2.38 unit on a scale
Standard Deviation 17.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C10D22
|
-1.17 unit on a scale
Standard Deviation 16.62
|
-2.33 unit on a scale
Standard Deviation 18.40
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C11D1
|
0.53 unit on a scale
Standard Deviation 15.25
|
-1.45 unit on a scale
Standard Deviation 19.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Choked when swallowing C11D22
|
-1.52 unit on a scale
Standard Deviation 18.96
|
2.15 unit on a scale
Standard Deviation 14.75
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C8D1
|
-1.25 unit on a scale
Standard Deviation 23.98
|
-4.94 unit on a scale
Standard Deviation 18.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C8D22
|
-3.29 unit on a scale
Standard Deviation 21.93
|
-3.59 unit on a scale
Standard Deviation 20.52
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C9D1
|
-6.67 unit on a scale
Standard Deviation 19.76
|
-4.84 unit on a scale
Standard Deviation 23.26
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C9D22
|
-2.22 unit on a scale
Standard Deviation 22.85
|
-0.61 unit on a scale
Standard Deviation 27.59
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C10D1
|
-6.06 unit on a scale
Standard Deviation 26.09
|
-2.98 unit on a scale
Standard Deviation 22.27
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C10D22
|
-3.51 unit on a scale
Standard Deviation 21.53
|
-2.33 unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C11D1
|
-6.35 unit on a scale
Standard Deviation 23.84
|
-1.45 unit on a scale
Standard Deviation 22.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C11D22
|
-8.33 unit on a scale
Standard Deviation 22.87
|
-2.15 unit on a scale
Standard Deviation 17.07
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C12D1
|
-5.03 unit on a scale
Standard Deviation 20.04
|
-2.44 unit on a scale
Standard Deviation 18.84
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C12D22
|
-9.91 unit on a scale
Standard Deviation 27.06
|
-5.33 unit on a scale
Standard Deviation 18.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C13D1
|
-4.17 unit on a scale
Standard Deviation 27.18
|
-3.81 unit on a scale
Standard Deviation 17.66
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C13D22
|
-3.33 unit on a scale
Standard Deviation 21.08
|
-0.00 unit on a scale
Standard Deviation 25.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C14D1
|
-4.27 unit on a scale
Standard Deviation 20.49
|
-2.22 unit on a scale
Standard Deviation 21.32
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C14D22
|
-2.08 unit on a scale
Standard Deviation 22.30
|
-3.51 unit on a scale
Standard Deviation 18.90
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C15D1
|
-0.95 unit on a scale
Standard Deviation 18.94
|
-2.47 unit on a scale
Standard Deviation 15.81
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C15D22
|
1.15 unit on a scale
Standard Deviation 25.95
|
-1.96 unit on a scale
Standard Deviation 21.96
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C16D1
|
-2.86 unit on a scale
Standard Deviation 18.74
|
-1.52 unit on a scale
Standard Deviation 21.77
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C16D22
|
-2.30 unit on a scale
Standard Deviation 17.66
|
-4.76 unit on a scale
Standard Deviation 17.82
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C17D1
|
-2.22 unit on a scale
Standard Deviation 21.32
|
-3.70 unit on a scale
Standard Deviation 15.71
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C17D22
|
-1.45 unit on a scale
Standard Deviation 23.52
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C18D1
|
-3.70 unit on a scale
Standard Deviation 16.88
|
-4.17 unit on a scale
Standard Deviation 16.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C18D22
|
-3.33 unit on a scale
Standard Deviation 18.42
|
-10.00 unit on a scale
Standard Deviation 16.10
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C19D1
|
-5.80 unit on a scale
Standard Deviation 16.37
|
-4.44 unit on a scale
Standard Deviation 17.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C19D22
|
-6.67 unit on a scale
Standard Deviation 17.44
|
-6.06 unit on a scale
Standard Deviation 13.48
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C20D1
|
-4.35 unit on a scale
Standard Deviation 15.26
|
-4.44 unit on a scale
Standard Deviation 17.21
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C20D22
|
-3.70 unit on a scale
Standard Deviation 19.43
|
-6.67 unit on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in Front of Other C21D1
|
-3.33 unit on a scale
Standard Deviation 14.91
|
-7.14 unit on a scale
Standard Deviation 19.30
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C22D1
|
-2.22 unit on a scale
Standard Deviation 15.26
|
-5.56 unit on a scale
Standard Deviation 19.25
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C22D22
|
0.00 unit on a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C23D1
|
-4.44 unit on a scale
Standard Deviation 17.21
|
-2.56 unit on a scale
Standard Deviation 21.35
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C23D22
|
-3.03 unit on a scale
Standard Deviation 10.05
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C24D1
|
-4.76 unit on a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C25D1
|
-8.33 unit on a scale
Standard Deviation 15.08
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C25D22
|
-3.03 unit on a scale
Standard Deviation 17.98
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C26D1
|
-7.69 unit on a scale
Standard Deviation 19.97
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C27D1
|
-6.06 unit on a scale
Standard Deviation 20.10
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others C28D1
|
-5.56 unit on a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others 30 day follow up
|
3.24 unit on a scale
Standard Deviation 24.49
|
0.37 unit on a scale
Standard Deviation 33.70
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Eating in front of others 90 day follow up
|
1.94 unit on a scale
Standard Deviation 25.23
|
0.81 unit on a scale
Standard Deviation 34.34
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth Baseline
|
21.92 unit on a scale
Standard Deviation 26.99
|
22.70 unit on a scale
Standard Deviation 26.83
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C1D22
|
5.68 unit on a scale
Standard Deviation 27.01
|
4.33 unit on a scale
Standard Deviation 27.17
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C2D1
|
1.78 unit on a scale
Standard Deviation 31.10
|
0.45 unit on a scale
Standard Deviation 28.03
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C2D22
|
3.56 unit on a scale
Standard Deviation 26.80
|
1.11 unit on a scale
Standard Deviation 29.67
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C3D1
|
1.05 unit on a scale
Standard Deviation 31.03
|
-1.53 unit on a scale
Standard Deviation 29.68
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C3D22
|
4.39 unit on a scale
Standard Deviation 30.85
|
1.13 unit on a scale
Standard Deviation 29.46
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C4D1
|
-0.39 unit on a scale
Standard Deviation 30.43
|
-0.62 unit on a scale
Standard Deviation 29.22
|
|
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Dry Mouth C4D22
|
1.09 unit on a scale
Standard Deviation 29.36
|
1.57 unit on a scale
Standard Deviation 29.05
|
SECONDARY outcome
Timeframe: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow upPopulation: FAS with available data was analyzed.
The GP instrument is a single assessment of overall pain. 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.
Outcome measures
| Measure |
mFOLFOX6 + Zolbetuximab
n=257 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=257 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C12D1
|
-0.30 units on a scale
Standard Deviation 3.42
|
-0.54 units on a scale
Standard Deviation 2.81
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C12D22
|
-0.14 units on a scale
Standard Deviation 2.82
|
-0.88 units on a scale
Standard Deviation 2.17
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C13D1
|
-0.79 units on a scale
Standard Deviation 3.51
|
-0.66 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C13D22
|
-0.63 units on a scale
Standard Deviation 3.01
|
-1.19 units on a scale
Standard Deviation 3.23
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C14D1
|
-0.21 units on a scale
Standard Deviation 2.91
|
-0.37 units on a scale
Standard Deviation 2.46
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C14D22
|
-0.44 units on a scale
Standard Deviation 3.70
|
-0.84 units on a scale
Standard Deviation 3.34
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C15D1
|
0.09 units on a scale
Standard Deviation 3.49
|
0.22 units on a scale
Standard Deviation 3.63
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C15D22
|
-0.38 units on a scale
Standard Deviation 3.81
|
-0.71 units on a scale
Standard Deviation 3.62
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C16D1
|
-0.60 units on a scale
Standard Deviation 3.91
|
-0.45 units on a scale
Standard Deviation 3.66
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C16D22
|
-0.97 units on a scale
Standard Deviation 3.23
|
-0.71 units on a scale
Standard Deviation 2.46
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C17D1
|
-0.03 units on a scale
Standard Deviation 2.94
|
-0.53 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C17D22
|
0.22 units on a scale
Standard Deviation 3.00
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C18D1
|
-0.62 units on a scale
Standard Deviation 3.11
|
-0.31 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C18D22
|
-1.14 units on a scale
Standard Deviation 2.87
|
-0.40 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C19D1
|
-1.04 units on a scale
Standard Deviation 3.24
|
-0.73 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C19D22
|
-0.50 units on a scale
Standard Deviation 2.33
|
-0.45 units on a scale
Standard Deviation 2.34
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C20D1
|
-0.43 units on a scale
Standard Deviation 3.26
|
0.60 units on a scale
Standard Deviation 3.07
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C20D22
|
-0.17 units on a scale
Standard Deviation 3.70
|
-0.20 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C21D1
|
-0.50 units on a scale
Standard Deviation 3.66
|
-0.79 units on a scale
Standard Deviation 2.36
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C21D22
|
0.57 units on a scale
Standard Deviation 2.90
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C22D1
|
0.07 units on a scale
Standard Deviation 3.47
|
-0.42 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C22D22
|
0.60 units on a scale
Standard Deviation 3.24
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C23D1
|
1.07 units on a scale
Standard Deviation 4.13
|
-0.54 units on a scale
Standard Deviation 2.63
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C23D22
|
1.27 units on a scale
Standard Deviation 4.13
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C24D1
|
1.43 units on a scale
Standard Deviation 4.54
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C25D1
|
2.33 units on a scale
Standard Deviation 3.03
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C25D22
|
1.45 units on a scale
Standard Deviation 3.30
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C26D1
|
1.08 units on a scale
Standard Deviation 3.77
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C27D1
|
1.55 units on a scale
Standard Deviation 3.75
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C28D1
|
1.42 units on a scale
Standard Deviation 3.55
|
—
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
30 day follow up
|
-0.19 units on a scale
Standard Deviation 2.99
|
0.39 units on a scale
Standard Deviation 3.16
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
90 Day follow up
|
-0.27 units on a scale
Standard Deviation 2.94
|
0.31 units on a scale
Standard Deviation 3.12
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C3D22
|
-0.62 units on a scale
Standard Deviation 3.16
|
-0.83 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C4D1
|
-0.86 units on a scale
Standard Deviation 2.61
|
-0.66 units on a scale
Standard Deviation 2.81
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C4D22
|
-0.51 units on a scale
Standard Deviation 3.02
|
-0.78 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C5D1
|
-0.53 units on a scale
Standard Deviation 2.91
|
-0.81 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C5D22
|
-0.54 units on a scale
Standard Deviation 2.89
|
-0.84 units on a scale
Standard Deviation 3.00
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C6D1
|
-0.63 units on a scale
Standard Deviation 3.13
|
-0.32 units on a scale
Standard Deviation 3.33
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C6D22
|
-0.68 units on a scale
Standard Deviation 2.91
|
-0.98 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C7D1
|
-0.46 units on a scale
Standard Deviation 2.87
|
-0.86 units on a scale
Standard Deviation 2.88
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C7D22
|
-0.31 units on a scale
Standard Deviation 3.00
|
-1.01 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C8D1
|
-0.69 units on a scale
Standard Deviation 2.54
|
-0.67 units on a scale
Standard Deviation 3.17
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C8D22
|
-0.79 units on a scale
Standard Deviation 3.28
|
-1.09 units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C9D1
|
-0.71 units on a scale
Standard Deviation 3.05
|
-1.18 units on a scale
Standard Deviation 2.04
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C9D22
|
-1.02 units on a scale
Standard Deviation 2.76
|
-1.13 units on a scale
Standard Deviation 2.71
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C10D1
|
-0.54 units on a scale
Standard Deviation 2.84
|
-0.75 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C10D22
|
-0.50 units on a scale
Standard Deviation 3.12
|
-0.74 units on a scale
Standard Deviation 3.09
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C11D1
|
-0.38 units on a scale
Standard Deviation 3.58
|
-0.96 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C11D22
|
-0.59 units on a scale
Standard Deviation 3.27
|
-0.77 units on a scale
Standard Deviation 1.89
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
Baseline
|
2.87 units on a scale
Standard Deviation 2.67
|
2.96 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C1D22
|
-0.55 units on a scale
Standard Deviation 2.85
|
-0.74 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C2D1
|
-0.75 units on a scale
Standard Deviation 2.94
|
-0.75 units on a scale
Standard Deviation 2.98
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C2D22
|
-0.67 units on a scale
Standard Deviation 3.11
|
-1.01 units on a scale
Standard Deviation 2.70
|
|
Change From Baseline in HRQoL Measured by Global Pain (GP)
C3D1
|
-0.87 units on a scale
Standard Deviation 2.88
|
-0.90 units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 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 |
mFOLFOX6 + Zolbetuximab
n=258 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
n=258 Participants
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility Baseline
|
1.40 units on a scale
Standard Deviation 0.73
|
1.40 units 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 C1D22
|
0.15 units on a scale
Standard Deviation 0.67
|
-0.01 units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C2D1
|
0.09 units on a scale
Standard Deviation 0.76
|
-0.05 units on a scale
Standard Deviation 0.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C2D22
|
0.03 units on a scale
Standard Deviation 0.76
|
-0.05 units 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 C3D1
|
0.09 units on a scale
Standard Deviation 0.85
|
-0.02 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C3D22
|
0.21 units on a scale
Standard Deviation 0.88
|
-0.04 units 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 C4D1
|
0.16 units on a scale
Standard Deviation 0.94
|
0.01 units 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 C4D22
|
0.16 units on a scale
Standard Deviation 0.90
|
0.13 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C5D1
|
0.15 units on a scale
Standard Deviation 0.89
|
0.18 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C5D22
|
0.27 units on a scale
Standard Deviation 0.96
|
0.16 units on a scale
Standard Deviation 0.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C6D1
|
0.20 units on a scale
Standard Deviation 0.82
|
0.20 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C6D22
|
0.17 units on a scale
Standard Deviation 0.90
|
0.23 units 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 C7D22
|
0.26 units on a scale
Standard Deviation 0.91
|
0.24 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C8D1
|
0.17 units on a scale
Standard Deviation 0.78
|
0.20 units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C8D22
|
0.10 units on a scale
Standard Deviation 0.61
|
0.12 units 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 C9D1
|
0.13 units on a scale
Standard Deviation 0.78
|
0.10 units 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 C9D22
|
0.11 units on a scale
Standard Deviation 0.82
|
0.09 units on a scale
Standard Deviation 0.62
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C10D1
|
0.12 units on a scale
Standard Deviation 0.85
|
0.11 units 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 C10D22
|
0.00 units on a scale
Standard Deviation 0.73
|
0.09 units 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 C11D1
|
0.16 units on a scale
Standard Deviation 0.88
|
0.17 units 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 C11D22
|
0.11 units on a scale
Standard Deviation 0.83
|
0.23 units 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 C12D1
|
0.08 units on a scale
Standard Deviation 0.76
|
0.32 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C12D22
|
0.21 units on a scale
Standard Deviation 0.81
|
0.31 units 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 C13D22
|
0.20 units on a scale
Standard Deviation 0.68
|
0.24 units on a scale
Standard Deviation 0.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C14D1
|
0.05 units on a scale
Standard Deviation 0.72
|
0.23 units on a scale
Standard Deviation 0.73
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C14D22
|
0.16 units on a scale
Standard Deviation 0.81
|
0.16 units 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 C15D1
|
0.23 units on a scale
Standard Deviation 0.84
|
0.15 units 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 C15D22
|
0.30 units on a scale
Standard Deviation 0.75
|
0.06 units 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 C16D22
|
0.03 units on a scale
Standard Deviation 0.68
|
0.29 units on a scale
Standard Deviation 0.73
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C17D1
|
0.23 units on a scale
Standard Deviation 0.86
|
0.17 units 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 C17D22
|
0.17 units 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 C18D1
|
0.15 units on a scale
Standard Deviation 1.10
|
0.19 units on a scale
Standard Deviation 0.40
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C18D22
|
0.05 units on a scale
Standard Deviation 0.67
|
0.20 units on a scale
Standard Deviation 0.42
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C19D22
|
0.20 units on a scale
Standard Deviation 0.52
|
0.27 units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C20D1
|
0.13 units on a scale
Standard Deviation 0.63
|
0.13 units on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C20D22
|
0.17 units on a scale
Standard Deviation 0.71
|
0.10 units 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
|
0.15 units on a scale
Standard Deviation 0.49
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C22D1
|
0.20 units on a scale
Standard Deviation 0.77
|
0.00 units 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 C16D1
|
0.20 units on a scale
Standard Deviation 0.83
|
0.14 units 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 C7D1
|
0.17 units on a scale
Standard Deviation 0.90
|
0.10 units 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 C19D1
|
0.09 units on a scale
Standard Deviation 0.51
|
0.27 units on a scale
Standard Deviation 0.46
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C13D1
|
0.02 units on a scale
Standard Deviation 0.73
|
0.20 units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C21D22
|
0.14 units 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 C12D22
|
-0.05 units on a scale
Standard Deviation 0.73
|
0.15 units on a scale
Standard Deviation 0.37
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C13DD1
|
-0.06 units on a scale
Standard Deviation 0.76
|
0.14 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C6D1
|
-0.20 units on a scale
Standard Deviation 0.82
|
-0.18 units on a scale
Standard Deviation 0.86
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C8D1
|
3.77 units on a scale
Standard Deviation 21.13
|
6.60 units on a scale
Standard Deviation 14.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C11D22
|
0.09 units on a scale
Standard Deviation 0.95
|
0.23 units 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 C12D1
|
-0.08 units on a scale
Standard Deviation 1.00
|
0.12 units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C12D22
|
0.00 units on a scale
Standard Deviation 0.93
|
0.23 units on a scale
Standard Deviation 0.71
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C22D22
|
0.55 units on a scale
Standard Deviation 0.82
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C23D1
|
0.31 units on a scale
Standard Deviation 0.70
|
0.00 units on a scale
Standard Deviation 0.41
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C23D22
|
0.09 units 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 C24D1
|
0.14 units on a scale
Standard Deviation 0.36
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C25D1
|
0.25 units on a scale
Standard Deviation 0.62
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C25D22
|
0.27 units on a scale
Standard Deviation 0.47
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C26D1
|
0.23 units on a scale
Standard Deviation 0.44
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C27D1
|
0.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility C28D1
|
0.17 units on a scale
Standard Deviation 0.39
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility 30 Day follow up
|
0.38 units on a scale
Standard Deviation 1.11
|
0.47 units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Mobility 90 Day follow up
|
0.51 units on a scale
Standard Deviation 1.09
|
0.53 units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care Baseline
|
1.23 units on a scale
Standard Deviation 0.57
|
1.21 units 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 C1DD22
|
0.11 units on a scale
Standard Deviation 0.66
|
0.07 units 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 C2D1
|
0.08 units on a scale
Standard Deviation 0.65
|
-0.04 units 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 C2D22
|
0.09 units on a scale
Standard Deviation 0.77
|
-0.01 units 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
|
0.06 units on a scale
Standard Deviation 0.69
|
0.06 units 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 C3D22
|
0.06 units on a scale
Standard Deviation 0.72
|
-0.01 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C4D1
|
0.08 units on a scale
Standard Deviation 0.81
|
0.03 units 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 C4D22
|
0.05 units on a scale
Standard Deviation 0.72
|
0.03 units 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 C5D1
|
0.10 units on a scale
Standard Deviation 0.86
|
0.05 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C5D22
|
0.16 units on a scale
Standard Deviation 0.82
|
0.09 units on a scale
Standard Deviation 0.57
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C6D1
|
0.07 units on a scale
Standard Deviation 0.66
|
0.10 units 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 C6D22
|
0.07 units on a scale
Standard Deviation 0.74
|
0.05 units 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 C7D1
|
0.11 units on a scale
Standard Deviation 0.75
|
0.11 units 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 C7D22
|
0.01 units on a scale
Standard Deviation 0.78
|
0.04 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C8D1
|
0.09 units on a scale
Standard Deviation 0.95
|
0.10 units 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 C8D22
|
-0.01 units on a scale
Standard Deviation 0.64
|
0.08 units 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
|
0.08 units on a scale
Standard Deviation 0.87
|
0.02 units on a scale
Standard Deviation 0.46
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C9D22
|
-0.02 units on a scale
Standard Deviation 0.81
|
0.04 units 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 C10D1
|
-0.03 units on a scale
Standard Deviation 0.80
|
0.11 units 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 C10D22
|
-0.04 units on a scale
Standard Deviation 0.80
|
0.09 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C11D1
|
0.00 units on a scale
Standard Deviation 0.93
|
0.11 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C11D22
|
-0.04 units on a scale
Standard Deviation 0.64
|
0.10 units on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C12D1
|
-0.04 units on a scale
Standard Deviation 0.76
|
0.20 units on a scale
Standard Deviation 0.40
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C13D22
|
-0.02 units on a scale
Standard Deviation 0.85
|
0.14 units on a scale
Standard Deviation 0.36
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C14D1
|
-0.08 units on a scale
Standard Deviation 0.74
|
0.10 units on a scale
Standard Deviation 0.31
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C14D22
|
0.03 units on a scale
Standard Deviation 0.86
|
0.16 units on a scale
Standard Deviation 0.37
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C15D1
|
-0.03 units on a scale
Standard Deviation 0.79
|
0.19 units on a scale
Standard Deviation 0.40
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C15D22
|
-0.03 units on a scale
Standard Deviation 0.85
|
0.12 units on a scale
Standard Deviation 0.33
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C16D1
|
0.00 units on a scale
Standard Deviation 0.84
|
0.09 units 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 C16D22
|
-0.10 units on a scale
Standard Deviation 0.82
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C17D1
|
0.03 units on a scale
Standard Deviation 1.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C17D22
|
0.13 units on a scale
Standard Deviation 0.92
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C18D1
|
0.00 units on a scale
Standard Deviation 0.92
|
0.06 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C18D22
|
-0.10 units on a scale
Standard Deviation 0.94
|
0.10 units on a scale
Standard Deviation 0.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C19D1
|
0.04 units on a scale
Standard Deviation 0.77
|
0.20 units on a scale
Standard Deviation 0.41
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C19D22
|
0.20 units on a scale
Standard Deviation 1.06
|
0.09 units on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C20D1
|
0.09 units on a scale
Standard Deviation 0.85
|
0.13 units 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 C20D22
|
0.06 units on a scale
Standard Deviation 0.80
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C21D1
|
0.10 units on a scale
Standard Deviation 0.64
|
0.14 units on a scale
Standard Deviation 0.36
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C21D22
|
0.29 units on a scale
Standard Deviation 0.73
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C22D1
|
0.20 units on a scale
Standard Deviation 0.77
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C22D22
|
0.18 units 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 C23D1
|
0.31 units on a scale
Standard Deviation 0.87
|
0.08 units 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 C23D22
|
0.27 units on a scale
Standard Deviation 0.79
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C24D1
|
0.21 units on a scale
Standard Deviation 0.89
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C25D1
|
0.00 units on a scale
Standard Deviation 0.43
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C25D22
|
0.09 units 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 C26D1
|
-0.08 units 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 C27D1
|
-0.18 units on a scale
Standard Deviation 0.40
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-care C28D1
|
-0.08 units on a scale
Standard Deviation 0.51
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Self-Care 30 Day follow up
|
0.21 units on a scale
Standard Deviation 0.90
|
0.30 units 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 90 Day follow up
|
0.35 units on a scale
Standard Deviation 0.90
|
0.39 units 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 Baseline
|
1.68 units on a scale
Standard Deviation 0.97
|
1.56 units on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C1D22
|
0.24 units on a scale
Standard Deviation 0.80
|
0.14 units 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 C2D1
|
0.08 units on a scale
Standard Deviation 0.87
|
-0.01 units 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 C2D22
|
0.05 units on a scale
Standard Deviation 0.86
|
-0.01 units 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 C3D1
|
0.05 units on a scale
Standard Deviation 0.91
|
0.01 units 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 C3D22
|
0.23 units on a scale
Standard Deviation 0.90
|
0.05 units 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 C4D1
|
0.06 units on a scale
Standard Deviation 0.92
|
0.04 units 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 C4D22
|
0.11 units on a scale
Standard Deviation 0.85
|
0.16 units 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 C5D1
|
0.13 units on a scale
Standard Deviation 0.93
|
0.15 units 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 C5D22
|
0.17 units on a scale
Standard Deviation 0.94
|
0.18 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C6D1
|
0.14 units on a scale
Standard Deviation 0.94
|
0.25 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C6D22
|
0.15 units on a scale
Standard Deviation 1.02
|
0.15 units 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
|
0.15 units on a scale
Standard Deviation 1.05
|
0.12 units 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 C7D22
|
0.15 units on a scale
Standard Deviation 1.10
|
0.05 units 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 C8D1
|
0.18 units on a scale
Standard Deviation 0.97
|
0.18 units 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 C8D22
|
0.03 units on a scale
Standard Deviation 1.05
|
0.09 units 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 C9D1
|
0.07 units on a scale
Standard Deviation 0.96
|
0.03 units 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 C9D22
|
0.13 units on a scale
Standard Deviation 0.99
|
0.07 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C10D1
|
-0.02 units on a scale
Standard Deviation 1.00
|
0.07 units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C10D22
|
-0.02 units on a scale
Standard Deviation 0.88
|
0.09 units 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 C11D1
|
-0.05 units on a scale
Standard Deviation 0.87
|
0.04 units 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 C13D1
|
0.04 units on a scale
Standard Deviation 0.82
|
0.14 units 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 C13D22
|
0.15 units on a scale
Standard Deviation 0.88
|
0.10 units 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 C14D1
|
0.03 units on a scale
Standard Deviation 0.84
|
0.27 units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C14D22
|
0.06 units on a scale
Standard Deviation 0.76
|
0.00 units on a scale
Standard Deviation 0.88
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C15D1
|
0.09 units on a scale
Standard Deviation 0.74
|
0.07 units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C15D22
|
0.13 units on a scale
Standard Deviation 1.04
|
-0.12 units 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 C16D1
|
0.20 units on a scale
Standard Deviation 1.08
|
0.05 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C16D22
|
-0.10 units on a scale
Standard Deviation 0.72
|
0.14 units 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 C17D1
|
0.23 units on a scale
Standard Deviation 0.97
|
0.00 units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C17D22
|
0.26 units 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 C18D1
|
-0.07 units on a scale
Standard Deviation 0.68
|
0.00 units on a scale
Standard Deviation 0.37
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C18D22
|
0.00 units on a scale
Standard Deviation 0.84
|
0.10 units 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 C19D1
|
0.13 units on a scale
Standard Deviation 0.76
|
0.13 units on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C19D22
|
0.20 units on a scale
Standard Deviation 0.77
|
0.00 units on a scale
Standard Deviation 0.45
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C20D1
|
0.04 units on a scale
Standard Deviation 0.64
|
0.07 units on a scale
Standard Deviation 0.46
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C20D22
|
0.11 units on a scale
Standard Deviation 0.83
|
-0.10 units on a scale
Standard Deviation 0.32
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C21D1
|
0.10 units on a scale
Standard Deviation 0.31
|
0.07 units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C21D22
|
0.14 units on a scale
Standard Deviation 0.36
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C22D1
|
0.13 units on a scale
Standard Deviation 0.52
|
0.08 units 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 C22D22
|
0.36 units 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 C23D1
|
0.50 units on a scale
Standard Deviation 0.63
|
0.00 units on a scale
Standard Deviation 0.41
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C23D22
|
0.18 units on a scale
Standard Deviation 0.40
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C24D1
|
0.36 units 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 C25D1
|
0.17 units on a scale
Standard Deviation 0.58
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C25D22
|
0.18 units on a scale
Standard Deviation 0.40
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C26D1
|
0.15 units on a scale
Standard Deviation 0.38
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C27D1
|
0.27 units on a scale
Standard Deviation 0.47
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities C28D1
|
0.17 units on a scale
Standard Deviation 0.39
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Usual Activities 30 Day follow up
|
0.29 units on a scale
Standard Deviation 1.13
|
0.40 units on a scale
Standard Deviation 1.02
|
|
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 units on a scale
Standard Deviation 1.12
|
0.59 units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort Baseline
|
1.93 units on a scale
Standard Deviation 0.87
|
1.98 units 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 C1D22
|
0.08 units on a scale
Standard Deviation 0.93
|
-0.15 units 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
|
-0.14 units on a scale
Standard Deviation 0.91
|
-0.36 units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C2D22
|
-0.14 units on a scale
Standard Deviation 0.88
|
-0.24 units 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 C3D1
|
-0.23 units on a scale
Standard Deviation 0.94
|
-0.31 units 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 C3D22
|
-0.11 units on a scale
Standard Deviation 0.88
|
-0.31 units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C4D1
|
-0.16 units on a scale
Standard Deviation 0.93
|
-0.28 units 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 C4D22
|
-0.14 units on a scale
Standard Deviation 0.89
|
-0.28 units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C5D1
|
-0.19 units on a scale
Standard Deviation 0.88
|
-0.22 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C5D22
|
-0.02 units on a scale
Standard Deviation 1.04
|
-0.19 units 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 C6D1
|
-0.18 units on a scale
Standard Deviation 0.87
|
-0.19 units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C6D22
|
-0.08 units on a scale
Standard Deviation 0.96
|
-0.26 units 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 C7D1
|
-0.15 units on a scale
Standard Deviation 0.91
|
-0.21 units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C7D22
|
-0.12 units on a scale
Standard Deviation 0.97
|
-0.30 units 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 C8D1
|
-0.12 units on a scale
Standard Deviation 0.91
|
-0.18 units 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 C8D22
|
-0.14 units on a scale
Standard Deviation 0.88
|
-0.34 units 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 C9D1
|
-0.21 units on a scale
Standard Deviation 1.02
|
-0.29 units 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 C9D22
|
-0.05 units on a scale
Standard Deviation 0.80
|
-0.31 units 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 C10D1
|
-0.20 units on a scale
Standard Deviation 0.95
|
-0.30 units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C10D22
|
-0.14 units on a scale
Standard Deviation 0.88
|
-0.35 units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C11D1
|
-0.22 units on a scale
Standard Deviation 0.89
|
-0.17 units on a scale
Standard Deviation 0.71
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C11D22
|
-0.11 units on a scale
Standard Deviation 0.83
|
-0.32 units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C12D1
|
-0.19 units on a scale
Standard Deviation 0.81
|
-0.15 units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C12D22
|
-0.18 units on a scale
Standard Deviation 0.95
|
-0.27 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C13D1
|
-0.13 units on a scale
Standard Deviation 0.89
|
-0.20 units 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 C13D22
|
0.07 units on a scale
Standard Deviation 0.93
|
-0.19 units on a scale
Standard Deviation 1.12
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C14D1
|
-0.05 units on a scale
Standard Deviation 0.83
|
-0.33 units on a scale
Standard Deviation 0.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C14D22
|
-0.09 units on a scale
Standard Deviation 0.89
|
-0.47 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C15D1
|
-0.14 units on a scale
Standard Deviation 0.73
|
-0.07 units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C15D22
|
-0.17 units on a scale
Standard Deviation 0.83
|
-0.35 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C16D1
|
-0.17 units on a scale
Standard Deviation 0.71
|
-0.14 units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C16D22
|
-0.28 units on a scale
Standard Deviation 0.80
|
-0.29 units on a scale
Standard Deviation 0.61
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C17D1
|
-0.23 units on a scale
Standard Deviation 0.73
|
-0.33 units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C17D22
|
-0.13 units on a scale
Standard Deviation 0.92
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C18D1
|
-0.26 units on a scale
Standard Deviation 0.90
|
0.00 units 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 C18D22
|
-0.43 units on a scale
Standard Deviation 0.81
|
-0.20 units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C19D1
|
-0.30 units on a scale
Standard Deviation 0.70
|
-0.07 units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C19D22
|
-0.10 units on a scale
Standard Deviation 0.72
|
-0.18 units 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 C20D1
|
-0.22 units on a scale
Standard Deviation 0.80
|
0.00 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C20D22
|
-0.28 units on a scale
Standard Deviation 0.75
|
0.10 units 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 C21D1
|
-0.25 units on a scale
Standard Deviation 0.64
|
-0.14 units on a scale
Standard Deviation 0.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C21D22
|
0.21 units on a scale
Standard Deviation 0.58
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C22D1
|
-0.20 units on a scale
Standard Deviation 0.68
|
-0.17 units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C22D22
|
0.00 units on a scale
Standard Deviation 0.77
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C23D1
|
-0.13 units on a scale
Standard Deviation 0.89
|
-0.23 units 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 C23D22
|
-0.09 units 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 C24D1
|
-0.07 units on a scale
Standard Deviation 1.14
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C25D1
|
-0.17 units on a scale
Standard Deviation 0.72
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C25D22
|
-0.09 units on a scale
Standard Deviation 0.70
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C26D1
|
-0.08 units on a scale
Standard Deviation 0.76
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C27D1
|
-0.27 units on a scale
Standard Deviation 0.79
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort C28D1
|
-0.25 units on a scale
Standard Deviation 0.97
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Pain/Discomfort 30 Day follow up
|
-0.06 units on a scale
Standard Deviation 0.96
|
0.17 units 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 90 day follow up
|
0.02 units on a scale
Standard Deviation 1.04
|
0.07 units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression Baseline
|
1.76 units on a scale
Standard Deviation 0.84
|
1.80 units 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 C1D22
|
-0.03 units on a scale
Standard Deviation 0.81
|
-0.09 units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C2D1
|
-0.09 units on a scale
Standard Deviation 0.82
|
-0.22 units on a scale
Standard Deviation 0.73
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C2D22
|
-0.09 units on a scale
Standard Deviation 0.78
|
-0.12 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C3D1
|
-0.14 units on a scale
Standard Deviation 0.80
|
-0.24 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C3D22
|
-0.10 units on a scale
Standard Deviation 0.85
|
-0.24 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C4D1
|
-0.22 units on a scale
Standard Deviation 0.78
|
-0.23 units 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 C4D22
|
-0.10 units on a scale
Standard Deviation 0.87
|
-0.17 units 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 C5D1
|
-0.15 units on a scale
Standard Deviation 0.80
|
-0.16 units on a scale
Standard Deviation 0.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C5D22
|
-0.11 units on a scale
Standard Deviation 0.97
|
-0.05 units 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 C6D22
|
-0.08 units on a scale
Standard Deviation 0.82
|
-0.14 units 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 C7D1
|
-0.12 units on a scale
Standard Deviation 0.94
|
-0.28 units 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 C7D22
|
-0.06 units on a scale
Standard Deviation 0.83
|
-0.19 units 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 C8D1
|
-0.18 units on a scale
Standard Deviation 0.83
|
-0.11 units 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 C8D22
|
-0.10 units on a scale
Standard Deviation 0.87
|
-0.22 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C9D1
|
-0.17 units on a scale
Standard Deviation 1.07
|
-0.19 units 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 C9D22
|
-0.08 units on a scale
Standard Deviation 0.97
|
-0.15 units 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 C10D1
|
-0.17 units on a scale
Standard Deviation 0.94
|
-0.27 units 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 C10D22
|
-0.16 units on a scale
Standard Deviation 0.86
|
-0.19 units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C11D1
|
-0.21 units on a scale
Standard Deviation 0.97
|
-0.15 units 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 C11D22
|
-0.20 units on a scale
Standard Deviation 0.94
|
-0.03 units on a scale
Standard Deviation 1.17
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C12D1
|
-0.09 units on a scale
Standard Deviation 0.97
|
-0.07 units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C12D22
|
-0.11 units on a scale
Standard Deviation 0.86
|
0.08 units 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 C13D1
|
-0.10 units on a scale
Standard Deviation 1.02
|
0.00 units 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 C13D22
|
-0.10 units on a scale
Standard Deviation 1.07
|
0.19 units 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 C14D1
|
-0.03 units on a scale
Standard Deviation 1.04
|
0.00 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C14D22
|
-0.19 units on a scale
Standard Deviation 1.03
|
-0.05 units on a scale
Standard Deviation 1.13
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C15D1
|
-0.26 units on a scale
Standard Deviation 0.92
|
-0.15 units 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 C15D22
|
-0.17 units on a scale
Standard Deviation 1.05
|
-0.12 units 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 C16D1
|
-0.29 units on a scale
Standard Deviation 1.05
|
-0.14 units 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 C16D22
|
-0.41 units on a scale
Standard Deviation 0.91
|
-0.14 units on a scale
Standard Deviation 0.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C17D1
|
-0.10 units on a scale
Standard Deviation 0.96
|
-0.33 units 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 C17D22
|
-0.26 units on a scale
Standard Deviation 1.01
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C18D1
|
-0.48 units on a scale
Standard Deviation 0.85
|
-0.06 units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C18D22
|
-0.33 units on a scale
Standard Deviation 0.73
|
-0.40 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C19D1
|
-0.30 units on a scale
Standard Deviation 0.56
|
-0.13 units on a scale
Standard Deviation 0.74
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C19D22
|
-0.25 units on a scale
Standard Deviation 0.72
|
-0.18 units 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 C20D1
|
-0.26 units on a scale
Standard Deviation 0.62
|
-0.20 units 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 C20D22
|
-0.39 units on a scale
Standard Deviation 0.78
|
-0.20 units 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 C21D1
|
-0.35 units on a scale
Standard Deviation 0.75
|
-0.21 units 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 C21D22
|
-0.36 units on a scale
Standard Deviation 0.63
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C22D1
|
-0.27 units on a scale
Standard Deviation 0.80
|
-0.33 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C22D22
|
0.00 units 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 C23D1
|
-0.06 units on a scale
Standard Deviation 1.06
|
-0.15 units 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 C23D22
|
-0.18 units 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 C24D1
|
0.00 units on a scale
Standard Deviation 1.04
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C25D1
|
-0.17 units on a scale
Standard Deviation 0.72
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C25D22
|
-0.27 units on a scale
Standard Deviation 0.65
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C26D1
|
-0.23 units on a scale
Standard Deviation 0.73
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression C27D1
|
-0.27 units 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 C28D1
|
-0.33 units on a scale
Standard Deviation 0.78
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Anxiety/Depression 30 Day follow up
|
0.04 units on a scale
Standard Deviation 1.01
|
0.12 units 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 90 Day follow up
|
0.01 units on a scale
Standard Deviation 1.02
|
0.00 units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale Baseline
|
68.91 units on a scale
Standard Deviation 19.15
|
67.95 units on a scale
Standard Deviation 19.78
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C1D22
|
-3.44 units on a scale
Standard Deviation 18.53
|
-0.21 units on a scale
Standard Deviation 15.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C2D1
|
0.05 units on a scale
Standard Deviation 18.05
|
4.10 units on a scale
Standard Deviation 17.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C2D22
|
0.63 units on a scale
Standard Deviation 18.37
|
2.25 units on a scale
Standard Deviation 19.26
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C3D1
|
1.16 units on a scale
Standard Deviation 18.61
|
5.57 units on a scale
Standard Deviation 18.23
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C3D22
|
-1.69 units on a scale
Standard Deviation 18.39
|
2.73 units on a scale
Standard Deviation 19.27
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C4D1
|
0.35 units on a scale
Standard Deviation 17.10
|
5.89 units on a scale
Standard Deviation 17.65
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C4D22
|
-1.11 units on a scale
Standard Deviation 19.16
|
3.39 units on a scale
Standard Deviation 17.41
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C5D1
|
-0.54 units on a scale
Standard Deviation 19.36
|
5.14 units on a scale
Standard Deviation 17.26
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C5D22
|
0.37 units on a scale
Standard Deviation 22.01
|
2.29 units on a scale
Standard Deviation 18.00
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C6D1
|
1.28 units on a scale
Standard Deviation 19.67
|
2.48 units on a scale
Standard Deviation 20.43
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C6D22
|
4.33 units on a scale
Standard Deviation 18.56
|
5.21 units on a scale
Standard Deviation 16.71
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C7D1
|
1.32 units on a scale
Standard Deviation 20.58
|
6.15 units on a scale
Standard Deviation 15.20
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C7D22
|
3.51 units on a scale
Standard Deviation 17.92
|
5.14 units on a scale
Standard Deviation 14.60
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C8D22
|
2.71 units on a scale
Standard Deviation 19.07
|
7.65 units on a scale
Standard Deviation 14.13
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C9D1
|
5.05 units on a scale
Standard Deviation 19.16
|
5.24 units on a scale
Standard Deviation 13.63
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C9D22
|
2.44 units on a scale
Standard Deviation 21.10
|
6.42 units on a scale
Standard Deviation 15.96
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C10D1
|
2.52 units on a scale
Standard Deviation 18.65
|
5.86 units on a scale
Standard Deviation 18.29
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
C10D22
|
3.23 units on a scale
Standard Deviation 17.27
|
6.72 units on a scale
Standard Deviation 15.81
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C11D1
|
5.10 units on a scale
Standard Deviation 17.23
|
7.33 units on a scale
Standard Deviation 14.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C11D22
|
3.96 units on a scale
Standard Deviation 15.63
|
5.58 units on a scale
Standard Deviation 15.74
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C12D1
|
1.06 units on a scale
Standard Deviation 18.03
|
3.95 units on a scale
Standard Deviation 17.66
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C12D22
|
-1.55 units on a scale
Standard Deviation 17.56
|
3.69 units on a scale
Standard Deviation 16.11
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C13D1
|
3.27 units on a scale
Standard Deviation 17.64
|
3.34 units on a scale
Standard Deviation 17.40
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C13D22
|
-0.29 units on a scale
Standard Deviation 18.30
|
1.67 units on a scale
Standard Deviation 17.02
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C14D1
|
-0.15 units on a scale
Standard Deviation 16.81
|
5.83 units on a scale
Standard Deviation 13.93
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C14D22
|
-0.25 units on a scale
Standard Deviation 18.75
|
3.53 units on a scale
Standard Deviation 14.98
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C15D1
|
-0.09 units on a scale
Standard Deviation 16.90
|
7.11 units on a scale
Standard Deviation 14.91
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C15D22
|
-2.63 units on a scale
Standard Deviation 23.87
|
2.29 units on a scale
Standard Deviation 17.85
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C16D1
|
2.43 units on a scale
Standard Deviation 16.37
|
3.86 units on a scale
Standard Deviation 15.94
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C16D22
|
2.00 units on a scale
Standard Deviation 15.26
|
0.36 units on a scale
Standard Deviation 12.34
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C17D1
|
2.50 units on a scale
Standard Deviation 16.74
|
1.72 units on a scale
Standard Deviation 14.90
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C17D22
|
-2.61 units on a scale
Standard Deviation 17.26
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C18D1
|
2.85 units on a scale
Standard Deviation 18.61
|
2.69 units on a scale
Standard Deviation 12.72
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C18D22
|
0.86 units on a scale
Standard Deviation 18.74
|
2.90 units 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 C19D1
|
5.39 units on a scale
Standard Deviation 16.57
|
3.33 units on a scale
Standard Deviation 14.11
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C19D22
|
-0.25 units on a scale
Standard Deviation 19.05
|
3.73 units on a scale
Standard Deviation 10.36
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C20D1
|
1.57 units on a scale
Standard Deviation 21.46
|
3.67 units on a scale
Standard Deviation 13.97
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C20D22
|
0.78 units on a scale
Standard Deviation 16.00
|
7.00 units on a scale
Standard Deviation 14.24
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C21D1
|
2.80 units on a scale
Standard Deviation 15.83
|
4.00 units on a scale
Standard Deviation 15.06
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C21D22
|
-4.64 units on a scale
Standard Deviation 12.29
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C22D1
|
1.33 units on a scale
Standard Deviation 17.37
|
4.25 units on a scale
Standard Deviation 16.19
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C22D22
|
-6.00 units on a scale
Standard Deviation 19.20
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C23D1
|
-2.25 units on a scale
Standard Deviation 18.36
|
5.31 units on a scale
Standard Deviation 17.77
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C23D22
|
-3.09 units on a scale
Standard Deviation 16.57
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C24D1
|
-3.43 units on a scale
Standard Deviation 18.81
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C25D1
|
-4.08 units on a scale
Standard Deviation 15.32
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C25D22
|
-4.64 units on a scale
Standard Deviation 14.43
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C26D1
|
1.69 units on a scale
Standard Deviation 16.79
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C27D1
|
1.45 units on a scale
Standard Deviation 17.15
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale C28D1
|
-0.42 units on a scale
Standard Deviation 17.61
|
—
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale 30 Day follow up
|
-1.33 units on a scale
Standard Deviation 18.53
|
-2.07 units on a scale
Standard Deviation 17.67
|
|
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Visual Analog Scale 90 Day follow up
|
-3.79 units on a scale
Standard Deviation 20.59
|
-4.84 units on a scale
Standard Deviation 19.73
|
SECONDARY outcome
Timeframe: Predose on C1D22, C3D1, C5D1, C7D1, C9D1Population: 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 |
mFOLFOX6 + Zolbetuximab
n=184 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C1D22
|
40.9 micrograms/mililiter (ug/mL)
Standard Deviation 37.2
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C3D1
|
70.1 micrograms/mililiter (ug/mL)
Standard Deviation 49.8
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C5D1
|
97.4 micrograms/mililiter (ug/mL)
Standard Deviation 50.8
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C7D1
|
118.0 micrograms/mililiter (ug/mL)
Standard Deviation 64.9
|
—
|
|
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
C9D1
|
135.0 micrograms/mililiter (ug/mL)
Standard Deviation 56.2
|
—
|
SECONDARY outcome
Timeframe: Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow upPopulation: Participants who were randomized to zolbetuximab + mFOLFOX6 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 |
mFOLFOX6 + Zolbetuximab
n=283 Participants
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 C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
mFOLFOX6+ Placebo
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
|
|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA)
C1D22
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
C3D1
|
3 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
C5D1
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
C7D1
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
C9D1
|
1 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
30 day follow up
|
4 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
90 day follow up
|
1 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
C1D1
|
2 Participants
|
—
|
Adverse Events
Folinic Acid / Leucovorin
Serious events: 262 serious events
Other events: 550 other events
Deaths: 414 deaths
Oxaliplatin
Serious events: 262 serious events
Other events: 550 other events
Deaths: 414 deaths
Placebo
Serious events: 129 serious events
Other events: 274 other events
Deaths: 217 deaths
Zolbetuximab
Serious events: 133 serious events
Other events: 276 other events
Deaths: 197 deaths
5-fluorouracil
Serious events: 262 serious events
Other events: 550 other events
Deaths: 414 deaths
Serious adverse events
| Measure |
Folinic Acid / Leucovorin
n=557 participants at risk
Participants received up to 12 treatments of folinic acid administered 400mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and29 of each cycle. Participants could continue to receive folinic acid on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
Oxaliplatin
n=557 participants at risk
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1,15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42days.
|
Placebo
n=278 participants at risk
Participants received anIV infusion (as a minimum of 2-hourinfusion) of placebo matched to zolbetuximab on C1D1followed by subsequent doses every 3 weeks starting from C1D22until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
Zolbetuximab
n=279 participants at risk
Participants received an IV infusion (as a minimum of 2-hourinfusion) ofzolbetuximab at a loading dose of 800mg/m\^2 on C1D1followed by subsequent doses of 600 mg/m\^2every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria .Each cycle wasapproximately 42 days.
|
5-fluorouracil
n=557 participants at risk
Participants received up to 12 treatments of5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over5 to 15 minutes followed by 2400mg/m\^2 over46-48 hours continuous IV infusion every 2weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
9/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/279 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.9%
8/279 • Number of events 8 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/279 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Cardiac failure
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Cardiac disorders
Pericardial effusion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Congenital, familial and genetic disorders
Dihydropyrimidine dehydrogenase deficiency
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
14/557 • Number of events 17 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
14/557 • Number of events 17 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.2%
9/278 • Number of events 12 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/279 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
14/557 • Number of events 17 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Ascites
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Constipation
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/278 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.9%
8/279 • Number of events 8 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
6/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/278 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Enteritis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Ileus
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.2%
12/557 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
12/557 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/278 • Number of events 8 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
7/279 • Number of events 13 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
12/557 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Lip swelling
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
31/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.6%
31/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
12/278 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.8%
19/279 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.6%
31/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Retching
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.90%
5/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Volvulus
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
38/557 • Number of events 59 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.8%
38/557 • Number of events 59 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
24/279 • Number of events 36 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.8%
38/557 • Number of events 59 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Asthenia
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/279 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.6%
9/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Chest pain
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Chills
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Complication associated with device
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Death
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Device related thrombosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Discomfort
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Fatigue
|
1.3%
7/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.3%
7/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.3%
7/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
General physical health deterioration
|
1.4%
8/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
8/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/278 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
8/557 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Inflammation
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Oedema peripheral
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Pneumatosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Pyrexia
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/278 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
7/279 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.3%
13/557 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.72%
4/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Jaundice
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Immune system disorders
Hypersensitivity
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Abdominal abscess
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Abdominal infection
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Abscess soft tissue
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Appendicitis
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Atypical pneumonia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Bacteraemia
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Bronchitis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
COVID-19
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Campylobacter infection
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Cellulitis
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Device related infection
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Herpes zoster
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Infectious pleural effusion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Large intestine infection
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Neutropenic sepsis
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Peritonitis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Pneumonia
|
2.7%
15/557 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.7%
15/557 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.9%
8/278 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
7/279 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.7%
15/557 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Pneumonia aspiration
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Pulmonary sepsis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Pyelonephritis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Sepsis
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/279 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Septic shock
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Alanine aminotransferase increased
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Blood creatinine increased
|
0.36%
2/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Blood potassium decreased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Ejection fraction decreased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
General physical condition abnormal
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Neutrophil count decreased
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Weight decreased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
7/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.3%
7/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/279 • Number of events 8 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.3%
7/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.9%
22/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
12/278 • Number of events 13 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
10/279 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Ataxia
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Dizziness
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Dysarthria
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Embolic stroke
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Headache
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Lethargy
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Polyneuropathy
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Presyncope
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Seizure
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Slow speech
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Syncope
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
4/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Psychiatric disorders
Suicide attempt
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Dysuria
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Haematuria
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Renal failure
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Urinary retention
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/278 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
6/557 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/278 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/278 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
2/557 • Number of events 2 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
10/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
10/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/278 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/279 • Number of events 6 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
10/557 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypertension
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.4%
4/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.90%
5/557 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Embolism
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Embolism venous
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypotension
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.72%
2/279 • Number of events 3 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.54%
3/557 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypovolaemic shock
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Venous thrombosis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Sudden death
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Abdominal sepsis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Biliary tract infection
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Clostridial sepsis
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Varicella
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/278 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/279 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Psychiatric disorders
Delirium
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Surgical and medical procedures
Euthanasia
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.00%
0/278 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.36%
1/279 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
0.18%
1/557 • Number of events 1 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
Other adverse events
| Measure |
Folinic Acid / Leucovorin
n=557 participants at risk
Participants received up to 12 treatments of folinic acid administered 400mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and29 of each cycle. Participants could continue to receive folinic acid on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
Oxaliplatin
n=557 participants at risk
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1,15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42days.
|
Placebo
n=278 participants at risk
Participants received anIV infusion (as a minimum of 2-hourinfusion) of placebo matched to zolbetuximab on C1D1followed by subsequent doses every 3 weeks starting from C1D22until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
Zolbetuximab
n=279 participants at risk
Participants received an IV infusion (as a minimum of 2-hourinfusion) ofzolbetuximab at a loading dose of 800mg/m\^2 on C1D1followed by subsequent doses of 600 mg/m\^2every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria .Each cycle wasapproximately 42 days.
|
5-fluorouracil
n=557 participants at risk
Participants received up to 12 treatments of5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over5 to 15 minutes followed by 2400mg/m\^2 over46-48 hours continuous IV infusion every 2weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.9%
211/557 • Number of events 616 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
37.9%
211/557 • Number of events 616 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
38.1%
106/278 • Number of events 307 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
37.6%
105/279 • Number of events 309 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
37.9%
211/557 • Number of events 616 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
30/557 • Number of events 57 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 57 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
13/278 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.1%
17/279 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 57 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.0%
195/557 • Number of events 674 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
35.0%
195/557 • Number of events 674 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
33.8%
94/278 • Number of events 334 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
36.2%
101/279 • Number of events 340 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
35.0%
195/557 • Number of events 674 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
74/557 • Number of events 180 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
13.3%
74/557 • Number of events 180 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.2%
45/278 • Number of events 113 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.4%
29/279 • Number of events 67 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
13.3%
74/557 • Number of events 180 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
39/557 • Number of events 50 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.0%
39/557 • Number of events 50 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.3%
23/278 • Number of events 27 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.7%
16/279 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.0%
39/557 • Number of events 50 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal pain
|
27.6%
154/557 • Number of events 274 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
27.6%
154/557 • Number of events 274 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
30.9%
86/278 • Number of events 137 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
24.4%
68/279 • Number of events 137 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
27.6%
154/557 • Number of events 274 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.4%
80/557 • Number of events 124 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.4%
80/557 • Number of events 124 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.9%
33/278 • Number of events 48 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.8%
47/279 • Number of events 76 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.4%
80/557 • Number of events 124 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Constipation
|
38.1%
212/557 • Number of events 334 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
38.1%
212/557 • Number of events 334 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
39.9%
111/278 • Number of events 180 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
36.2%
101/279 • Number of events 154 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
38.1%
212/557 • Number of events 334 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.5%
237/557 • Number of events 477 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
42.5%
237/557 • Number of events 477 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
45.0%
125/278 • Number of events 275 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
40.1%
112/279 • Number of events 202 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
42.5%
237/557 • Number of events 477 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
48/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
48/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.2%
20/278 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.0%
28/279 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
48/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
43/557 • Number of events 62 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.7%
43/557 • Number of events 62 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.6%
21/278 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.9%
22/279 • Number of events 28 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.7%
43/557 • Number of events 62 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.4%
30/557 • Number of events 32 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 32 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.8%
16/278 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/279 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 32 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Nausea
|
71.1%
396/557 • Number of events 1221 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
71.1%
396/557 • Number of events 1221 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
61.2%
170/278 • Number of events 405 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
81.0%
226/279 • Number of events 816 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
71.1%
396/557 • Number of events 1221 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
119/557 • Number of events 226 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
21.4%
119/557 • Number of events 226 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
21.2%
59/278 • Number of events 93 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
21.5%
60/279 • Number of events 133 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
21.4%
119/557 • Number of events 226 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Vomiting
|
49.9%
278/557 • Number of events 732 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
49.9%
278/557 • Number of events 732 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
35.3%
98/278 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
64.5%
180/279 • Number of events 557 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
49.9%
278/557 • Number of events 732 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Asthenia
|
23.5%
131/557 • Number of events 339 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
23.5%
131/557 • Number of events 339 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
22.3%
62/278 • Number of events 141 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
24.7%
69/279 • Number of events 198 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
23.5%
131/557 • Number of events 339 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Chills
|
4.7%
26/557 • Number of events 29 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
26/557 • Number of events 29 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
10/278 • Number of events 11 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.7%
16/279 • Number of events 18 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
26/557 • Number of events 29 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Fatigue
|
31.4%
175/557 • Number of events 414 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
31.4%
175/557 • Number of events 414 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
33.1%
92/278 • Number of events 224 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
29.7%
83/279 • Number of events 190 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
31.4%
175/557 • Number of events 414 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Malaise
|
5.4%
30/557 • Number of events 76 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 76 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.2%
9/278 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
21/279 • Number of events 55 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
30/557 • Number of events 76 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Oedema peripheral
|
14.0%
78/557 • Number of events 104 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.0%
78/557 • Number of events 104 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.7%
27/278 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
18.3%
51/279 • Number of events 70 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.0%
78/557 • Number of events 104 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Pyrexia
|
18.3%
102/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
18.3%
102/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.9%
47/278 • Number of events 73 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
19.7%
55/279 • Number of events 102 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
18.3%
102/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
COVID-19
|
8.6%
48/557 • Number of events 53 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
48/557 • Number of events 53 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
24/278 • Number of events 27 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
24/279 • Number of events 26 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
48/557 • Number of events 53 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Oral candidiasis
|
3.4%
19/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.4%
19/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.8%
5/279 • Number of events 5 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.4%
19/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
24/557 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
24/557 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.2%
9/278 • Number of events 13 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/279 • Number of events 20 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
24/557 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Alanine aminotransferase increased
|
14.9%
83/557 • Number of events 204 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.9%
83/557 • Number of events 204 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.3%
48/278 • Number of events 130 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.5%
35/279 • Number of events 74 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.9%
83/557 • Number of events 204 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Aspartate aminotransferase increased
|
17.1%
95/557 • Number of events 225 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.1%
95/557 • Number of events 225 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.2%
45/278 • Number of events 126 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.9%
50/279 • Number of events 99 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.1%
95/557 • Number of events 225 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
46/557 • Number of events 95 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.3%
46/557 • Number of events 95 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
25/278 • Number of events 63 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
21/279 • Number of events 32 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.3%
46/557 • Number of events 95 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Neutrophil count decreased
|
33.2%
185/557 • Number of events 772 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
33.2%
185/557 • Number of events 772 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
32.0%
89/278 • Number of events 413 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
34.4%
96/279 • Number of events 359 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
33.2%
185/557 • Number of events 772 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Platelet count decreased
|
16.2%
90/557 • Number of events 257 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.2%
90/557 • Number of events 257 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.6%
49/278 • Number of events 150 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.7%
41/279 • Number of events 107 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.2%
90/557 • Number of events 257 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Weight decreased
|
20.3%
113/557 • Number of events 170 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
20.3%
113/557 • Number of events 170 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
20.1%
56/278 • Number of events 89 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
20.4%
57/279 • Number of events 81 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
20.3%
113/557 • Number of events 170 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
White blood cell count decreased
|
17.4%
97/557 • Number of events 492 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.4%
97/557 • Number of events 492 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.5%
46/278 • Number of events 256 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
18.3%
51/279 • Number of events 236 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.4%
97/557 • Number of events 492 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.8%
233/557 • Number of events 458 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
41.8%
233/557 • Number of events 458 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
34.9%
97/278 • Number of events 199 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
48.7%
136/279 • Number of events 259 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
41.8%
233/557 • Number of events 458 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.5%
64/557 • Number of events 153 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.5%
64/557 • Number of events 153 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.5%
18/278 • Number of events 36 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.5%
46/279 • Number of events 117 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.5%
64/557 • Number of events 153 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.0%
39/557 • Number of events 82 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.0%
39/557 • Number of events 82 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.2%
9/278 • Number of events 10 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.8%
30/279 • Number of events 72 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.0%
39/557 • Number of events 82 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
89/557 • Number of events 167 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.0%
89/557 • Number of events 167 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.4%
40/278 • Number of events 66 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
17.6%
49/279 • Number of events 101 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.0%
89/557 • Number of events 167 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
27/557 • Number of events 41 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.8%
27/557 • Number of events 41 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
12/278 • Number of events 15 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/279 • Number of events 26 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.8%
27/557 • Number of events 41 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.7%
32/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.7%
32/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.5%
18/279 • Number of events 27 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.7%
32/557 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
47/557 • Number of events 63 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.4%
47/557 • Number of events 63 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
25/278 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.9%
22/279 • Number of events 28 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.4%
47/557 • Number of events 63 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
70/557 • Number of events 89 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.6%
70/557 • Number of events 89 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.2%
34/278 • Number of events 42 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.9%
36/279 • Number of events 47 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.6%
70/557 • Number of events 89 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
25/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.5%
25/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/278 • Number of events 18 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
10/279 • Number of events 12 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.5%
25/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Dizziness
|
11.5%
64/557 • Number of events 96 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.5%
64/557 • Number of events 96 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.7%
27/278 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
13.3%
37/279 • Number of events 61 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.5%
64/557 • Number of events 96 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Dysgeusia
|
15.1%
84/557 • Number of events 112 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
15.1%
84/557 • Number of events 112 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
14.4%
40/278 • Number of events 52 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
15.8%
44/279 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
15.1%
84/557 • Number of events 112 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Headache
|
12.4%
69/557 • Number of events 113 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.4%
69/557 • Number of events 113 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.6%
35/278 • Number of events 53 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.2%
34/279 • Number of events 60 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
12.4%
69/557 • Number of events 113 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.1%
45/557 • Number of events 94 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.1%
45/557 • Number of events 94 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.9%
22/278 • Number of events 37 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.2%
23/279 • Number of events 57 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.1%
45/557 • Number of events 94 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Paraesthesia
|
16.3%
91/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.3%
91/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.9%
47/278 • Number of events 87 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
15.8%
44/279 • Number of events 88 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
16.3%
91/557 • Number of events 175 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.6%
226/557 • Number of events 549 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
40.6%
226/557 • Number of events 549 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
42.8%
119/278 • Number of events 288 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
38.4%
107/279 • Number of events 261 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
40.6%
226/557 • Number of events 549 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Psychiatric disorders
Insomnia
|
10.1%
56/557 • Number of events 73 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.1%
56/557 • Number of events 73 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
25/278 • Number of events 29 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.1%
31/279 • Number of events 44 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.1%
56/557 • Number of events 73 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
60/557 • Number of events 80 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.8%
60/557 • Number of events 80 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.8%
30/278 • Number of events 38 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.8%
30/279 • Number of events 42 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
10.8%
60/557 • Number of events 80 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
53/557 • Number of events 79 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.5%
53/557 • Number of events 79 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.5%
32/278 • Number of events 44 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
21/279 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.5%
53/557 • Number of events 79 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.2%
40/557 • Number of events 45 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.2%
40/557 • Number of events 45 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.4%
26/278 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/279 • Number of events 15 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.2%
40/557 • Number of events 45 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.2%
29/557 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.2%
29/557 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
12/278 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.1%
17/279 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.2%
29/557 • Number of events 35 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
42/557 • Number of events 43 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
42/557 • Number of events 43 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.6%
21/278 • Number of events 22 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
21/279 • Number of events 21 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.5%
42/557 • Number of events 43 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.3%
35/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.3%
35/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
13/278 • Number of events 13 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.9%
22/279 • Number of events 26 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.3%
35/557 • Number of events 39 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.4%
47/557 • Number of events 74 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.4%
47/557 • Number of events 74 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.9%
22/278 • Number of events 31 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
25/279 • Number of events 43 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.4%
47/557 • Number of events 74 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.0%
50/557 • Number of events 65 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
50/557 • Number of events 65 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.4%
26/278 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.6%
24/279 • Number of events 32 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.0%
50/557 • Number of events 65 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
40/557 • Number of events 48 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.2%
40/557 • Number of events 48 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
8.3%
23/278 • Number of events 28 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
6.1%
17/279 • Number of events 20 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.2%
40/557 • Number of events 48 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.1%
23/557 • Number of events 31 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.1%
23/557 • Number of events 31 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/278 • Number of events 18 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.9%
8/279 • Number of events 13 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.1%
23/557 • Number of events 31 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypertension
|
9.7%
54/557 • Number of events 115 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.7%
54/557 • Number of events 115 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
7.6%
21/278 • Number of events 33 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
11.8%
33/279 • Number of events 82 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
9.7%
54/557 • Number of events 115 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
24/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
24/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
10/278 • Number of events 14 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/279 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.3%
24/557 • Number of events 30 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
General disorders
Mucosal inflammation
|
3.6%
20/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
20/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.2%
6/279 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.6%
20/557 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Investigations
Blood bilirubin increased
|
3.9%
22/557 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/278 • Number of events 27 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.5%
7/279 • Number of events 7 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 34 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
26/557 • Number of events 52 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
26/557 • Number of events 52 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.0%
11/278 • Number of events 23 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.4%
15/279 • Number of events 29 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
26/557 • Number of events 52 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Psychiatric disorders
Anxiety
|
3.9%
22/557 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
2.9%
8/278 • Number of events 9 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/279 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.9%
22/557 • Number of events 25 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
17/557 • Number of events 19 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.1%
17/557 • Number of events 19 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 15 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
1.1%
3/279 • Number of events 4 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
3.1%
17/557 • Number of events 19 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
|
Vascular disorders
Hypotension
|
4.8%
27/557 • Number of events 36 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.8%
27/557 • Number of events 36 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
5.0%
14/278 • Number of events 16 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.7%
13/279 • Number of events 20 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
4.8%
27/557 • Number of events 36 • All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
|
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