Trial Outcomes & Findings for NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed (NCT NCT01098266)
NCT ID: NCT01098266
Last Updated: 2019-09-17
Results Overview
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months
Results posted on
2019-09-17
Participant Flow
Study Period: April 12th, 2010(First enrolment); January 21st, 2013 (date of last enrolment); April 29th, 2014 (cut-off date). 15 clinical sites in Italy, 10 in UK, 7 in USA, 4 in Belgium, 2 in Canada, 2 in Netherland, 2 in Poland, 1 in Egypt, 1 in Ireland;1 in Sweden
Before randomization, the physician had to decide for each patient if he/she was candidate to either Best Supportive Care (BSC) alone or combined with single-agent chemotherapy.
Participant milestones
| Measure |
A: NGR-hTNF + BIC
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
193
|
193
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
A: NGR-hTNF + BIC
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Baseline characteristics by cohort
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
92 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
108 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
67 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
79 participants
n=5 Participants
|
84 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
49 participants
n=5 Participants
|
46 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 monthsDefined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Overall Survival (OS)
|
8.5 months
Interval 7.2 to 9.9
|
8.0 months
Interval 6.6 to 8.9
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 monthsDefined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.4 months
Interval 2.7 to 4.1
|
3.0 months
Interval 2.3 to 3.7
|
SECONDARY outcome
Timeframe: Assessed every 6-12 weeks, up to 100 weeksDisease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Disease Control Rate (DCR)
Disease control rate (DCR)
|
114 Participants
|
109 Participants
|
|
Disease Control Rate (DCR)
Complete or partial response (CR o PR)
|
3 Participants
|
6 Participants
|
|
Disease Control Rate (DCR)
Stable disease (SD)
|
111 Participants
|
103 Participants
|
|
Disease Control Rate (DCR)
Progressive disease (PD)
|
51 Participants
|
71 Participants
|
|
Disease Control Rate (DCR)
Nonassessable (NA)
|
35 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Assessed every 6-12 weeks, up to 100 weeksPopulation: Duration of disease control ≥ 6 months
Measured from the date of randomization until disease progression, or death due to any cause
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Number of Partecipants With Disease Control for ≥ 6 Months
|
84 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Assessed every 6-12 weeks, up to 100 weeksPopulation: The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386)
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=193 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=193 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Number of Partecipants With Adverse Events
Study-emergent AEs of grade 4
|
22 participants
|
19 participants
|
|
Number of Partecipants With Adverse Events
Study-emergent AEs of grade 5
|
12 participants
|
13 participants
|
|
Number of Partecipants With Adverse Events
Study-emergent AEs of any grade
|
191 participants
|
185 participants
|
|
Number of Partecipants With Adverse Events
Study-emergent AEs of grade 3
|
102 participants
|
86 participants
|
|
Number of Partecipants With Adverse Events
Treatment-related AEs of grade 5
|
0 participants
|
0 participants
|
|
Number of Partecipants With Adverse Events
Treatment discontinuation due to AEs
|
31 participants
|
24 participants
|
SECONDARY outcome
Timeframe: from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)Population: Participants with a worsening in the average symptom burden index by 25%.
Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=175 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=185 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Time to LCSS Symptomatic Progression
|
3.2 months
Interval 2.1 to 4.4
|
3.0 months
Interval 2.8 to 3.4
|
SECONDARY outcome
Timeframe: Assessed every 6-12 weeks, up to 100 weeksMedical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.
Outcome measures
| Measure |
A: NGR-hTNF + BIC
n=200 Participants
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=200 Participants
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
HYPNOTICS AND SEDATIVES
|
14 Participants
|
14 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
HYPOTHALAMIC HORMONES
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER DRUGS FOR ACID RELATED DISORDERS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER DRUGS FOR OBSTRUCTIVE
|
7 Participants
|
8 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
TETRACYCLINES
|
0 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
THYROID PREPARATIONS
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
|
1 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
UROLOGICALS
|
3 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VASODILATORS USED IN CARDIAC DISEASES
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CA
|
3 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ACE INHIBITORS, COMBINATIONS
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ACE INHIBITORS, PLAIN
|
5 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ADRENERGICS, INHALANTS
|
7 Participants
|
10 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
AMINOGLYCOSIDE ANTIBACTERIALS
|
2 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANESTHETICS, LOCAL
|
0 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANGIOTENSIN II ANTAGONISTS,COMBINATIONS
|
1 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANGIOTENSIN II ANTAGONISTS, plain
|
2 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTACIDS
|
7 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
|
13 Participants
|
7 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIADRENERGIC AGENTS CENTRALLY ACTING
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIADRENERGIC AGENTS PERIPHERALLY ACTING
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIANDROGENS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIARRHYTHMICS, CLASS I AND III
|
4 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIBIOTICS FOR TOPICAL USE
|
0 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIDEPRESSANTS
|
17 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIDIARRHEAL MICROORGANISMS
|
2 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIEMETICS AND ANTINAUSEANTS
|
107 Participants
|
110 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIEPILEPTICS
|
3 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIFIBRINOLYTICS
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIFUNGALS FOR TOPICAL USE
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIGLAUCOMA PREPARATIONS AND MIOTICS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIGOUT PREPARATIONS
|
10 Participants
|
12 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIHISTAMINES FOR SYSTEMIC USE
|
66 Participants
|
31 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIINFECTIVES
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COM
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIINFLAMMATORY ANANTIRHEUMATIC PRODUCTSD
|
58 Participants
|
65 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIMETABOLITES
|
1 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIMYCOTICS FOR SYSTEMIC USE
|
15 Participants
|
14 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIPROPULSIVES
|
4 Participants
|
8 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIPRURITICS
|
3 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIPSYCHOTICS
|
7 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTITHROMBOTIC AGENTS
|
41 Participants
|
42 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANTIVERTIGO PREPARATIONS
|
2 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ANXIOLYTICS
|
24 Participants
|
16 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ASCORBIC ACID (VITAMIN C)
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BACTERIAL VACCINES
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BELLADONNA AND DERIVATIVES
|
3 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BETA BLOCKING AGENTS AND OTHER ANTIHYPERTENSIVES
|
11 Participants
|
15 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
|
38 Participants
|
29 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BILE THERAPY
|
1 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BLOOD AND RELATED PRODUCTS
|
21 Participants
|
26 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
BLOOD GLUCOSE LOWERING DRUGS EXCL. INSULINS
|
2 Participants
|
6 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CALCIUM
|
19 Participants
|
12 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CAPILLARY STABILIZING
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CARDIAC GLYCOSIDES
|
1 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CARDIAC STIMULANTS EXCL CARDIAC GLYCOSIDES
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
|
138 Participants
|
108 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
CORTICOSTEROIDS, PLAIN
|
2 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
COUGH SUPPRESSANTS AND EXPECTORANTS, COMBINATIONS
|
2 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPEC
|
7 Participants
|
17 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DECONGESTANTS AND ANTIALLERGICS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DIRECT ACTING ANTIVIRALS
|
2 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DIURETICS AND POTASSIUM-SPARING AGENTS
|
6 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS AFFECTING BONE
|
2 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS FOR CONSTIPATION
|
39 Participants
|
63 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
|
3 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REF
|
74 Participants
|
71 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS FOR TREATMENT OF TUBERCULOSIS
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
|
4 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
ECTOPARASITICIDES, INC SCABICIDESL.
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
EMOLLIENTS AND PROTECTIVES
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
EXPECTORANTS EXCL COMBINATIONS WITH COUGH SUPPR.
|
14 Participants
|
9 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
HIGH-CEILING DIURETICS
|
19 Participants
|
20 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
HORMONES AND RELATED AGENTS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
I.V. SOLUTION ADDITIVES
|
17 Participants
|
21 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
I.V. SOLUTIONS
|
6 Participants
|
10 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
IMMUNOSTIMULANTS
|
20 Participants
|
19 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
INSULINS AND ANALOGUES
|
5 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
INTESTINAL ANTIINFECTIVES
|
3 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
IRON PREPARATIONS
|
14 Participants
|
9 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
LIPID MODIFYING AGENTS, PLAIN
|
4 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
LOW-CEILING DIURETICS, EXCL THIAZIDES
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
|
8 Participants
|
14 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
MULTIVITAMINS, COMBINATIONS
|
1 Participants
|
4 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
MULTIVITAMINS, PLAIN
|
4 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
MYDRIATICS AND CYCLOPLEGICS
|
2 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OPIOIDS
|
135 Participants
|
160 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER ANALGESICS AND ANTIPYRETICSD
|
105 Participants
|
93 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER ANTIANEMIC PREPARATIONS
|
20 Participants
|
20 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER ANTIBACTERIALS
|
4 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER ANTIDIARRHEALS
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER ANTINEOPLASTIC AGENTS
|
0 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER BETA-LACTAM ANTIBACTERIALS
|
8 Participants
|
9 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER CARDIAC PREPARATIONS
|
3 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER MINERAL SUPPLEMENTS
|
4 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER NUTRIENTS
|
4 Participants
|
7 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER OPHTHALMOLOGICALS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER PLAIN VITAMIN PREPARATIONS
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER RESPIRATORY SYSTEM PRODUCTS
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEA
|
3 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
OTHER VITAMIN PRODUCTS, COMBINATIONS
|
1 Participants
|
2 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
PERIPHERAL VASODILATORS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
POTASSIUM
|
4 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
POTASSIUM-SPARING AGENTS
|
1 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
PROPULSIVES
|
68 Participants
|
87 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
PSYCHOLEPTICS AND PSYCHOANALEPTICS
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
PSYCHOSTIMULANTS,
|
0 Participants
|
1 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
QUINOLONE ANTIBACTERIALS
|
31 Participants
|
36 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VA
|
1 Participants
|
6 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
STOMATOLOGICAL PREPARATIONS
|
20 Participants
|
19 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
SULFONAMIDES AND TRIMETHOPRIM
|
2 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VIRAL VACCINES
|
1 Participants
|
0 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VITAMIN A AND D
|
0 Participants
|
5 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VITAMIN B1, PLAIN AND IN COMBINATION WITH VITAMIN
|
0 Participants
|
3 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VITAMIN B12 AND FOLIC ACID
|
7 Participants
|
11 Participants
|
|
Evaluation of Medical Care Utilization in the Two Treatment Arms
VITAMIN K AND OTHER HEMOSTATICS
|
1 Participants
|
3 Participants
|
Adverse Events
A: NGR-hTNF + BIC
Serious events: 56 serious events
Other events: 190 other events
Deaths: 12 deaths
B: Placebo+BIC
Serious events: 54 serious events
Other events: 185 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
A: NGR-hTNF + BIC
n=193 participants at risk
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=193 participants at risk
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic fever
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain mets
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Immune system disorders
Brain mets
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
General disorders
Chills
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
General disorders
Mucositis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Through study completation, an average of 2 years
|
|
General disorders
Pyrexia
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
General disorders
Death
|
1.6%
3/193 • Number of events 3 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
General disorders
Hyperpyrexia
|
0.52%
1/193 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
General disorders
Ischaemic ulcer to left heel
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
General disorders
Chest pain
|
1.6%
3/193 • Number of events 3 • Through study completation, an average of 2 years
|
1.6%
3/193 • Number of events 3 • Through study completation, an average of 2 years
|
|
General disorders
Deterioration of clinical status
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
General disorders
Admitted for pain control
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
General disorders
Fatigue
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Uncertain study medication dose delivered
|
2.1%
4/193 • Number of events 4 • Through study completation, an average of 2 years
|
4.7%
9/193 • Number of events 9 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Drug infusion reaction
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Injury, poisoning and procedural complications
Occipital trauma
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Cardiac disorder
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Cardiac failure
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
4/193 • Number of events 7 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Infection (chest) with normal ANC
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural pain
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
2/193 • Number of events 3 • Through study completation, an average of 2 years
|
2.1%
4/193 • Number of events 5 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.00%
0/193 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Right hemispheric cerebrovascular accident
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/193 • Through study completation, an average of 2 years
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Abdominal ascites
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Hepatobiliary disorders
Acute hepatitis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Renal and urinary disorders
Abnormal renal function
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain right chest wall + right shoulder
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Through study completation, an average of 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/193 • Through study completation, an average of 2 years
|
1.6%
3/193 • Number of events 3 • Through study completation, an average of 2 years
|
|
Infections and infestations
Neutropenic sepsis
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
Sepsis
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
Infection - source unknown
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Infections and infestations
Viral gastroenteritis
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Cardiac disorders
Cardiac arresr
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
2/193 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
General disorders
Condition aggraveted
|
2.1%
4/193 • Number of events 4 • Through study completation, an average of 2 years
|
2.6%
5/193 • Number of events 5 • Through study completation, an average of 2 years
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.0%
2/193 • Number of events 2 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Infections and infestations
. Respiratory Tract Infection
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Metabolism and nutrition disorders
Cachexia
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
|
Metabolism and nutrition disorders
Pleural Mesothelioma
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Jacksonian seizure
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
0.00%
0/193 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/193 • Through study completation, an average of 2 years
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
Other adverse events
| Measure |
A: NGR-hTNF + BIC
n=193 participants at risk
NGR-hTNF plus Best Investigator's Choice
NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
B: Placebo+BIC
n=193 participants at risk
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
|
|---|---|---|
|
Vascular disorders
Hypertension
|
6.2%
12/193 • Number of events 16 • Through study completation, an average of 2 years
|
6.2%
12/193 • Number of events 15 • Through study completation, an average of 2 years
|
|
Vascular disorders
Hypotension
|
5.2%
10/193 • Number of events 12 • Through study completation, an average of 2 years
|
3.6%
7/193 • Number of events 9 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.5%
57/193 • Number of events 162 • Through study completation, an average of 2 years
|
31.1%
60/193 • Number of events 119 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
34/193 • Number of events 58 • Through study completation, an average of 2 years
|
21.8%
42/193 • Number of events 79 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.5%
26/193 • Number of events 56 • Through study completation, an average of 2 years
|
11.9%
23/193 • Number of events 47 • Through study completation, an average of 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.4%
24/193 • Number of events 85 • Through study completation, an average of 2 years
|
10.4%
20/193 • Number of events 24 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysponoea
|
32.6%
63/193 • Number of events 94 • Through study completation, an average of 2 years
|
29.0%
56/193 • Number of events 80 • Through study completation, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.2%
39/193 • Number of events 59 • Through study completation, an average of 2 years
|
24.4%
47/193 • Number of events 71 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Dizziness
|
5.7%
11/193 • Number of events 12 • Through study completation, an average of 2 years
|
6.2%
12/193 • Number of events 14 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Dysgeusia
|
5.2%
10/193 • Number of events 10 • Through study completation, an average of 2 years
|
3.1%
6/193 • Number of events 7 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Headache
|
7.8%
15/193 • Number of events 16 • Through study completation, an average of 2 years
|
6.7%
13/193 • Number of events 15 • Through study completation, an average of 2 years
|
|
Nervous system disorders
Pheripheral neuropathy
|
6.2%
12/193 • Number of events 20 • Through study completation, an average of 2 years
|
6.2%
12/193 • Number of events 15 • Through study completation, an average of 2 years
|
|
General disorders
Chills
|
53.9%
104/193 • Number of events 462 • Through study completation, an average of 2 years
|
11.9%
23/193 • Number of events 29 • Through study completation, an average of 2 years
|
|
General disorders
Fatigue
|
48.2%
93/193 • Number of events 166 • Through study completation, an average of 2 years
|
48.7%
94/193 • Number of events 180 • Through study completation, an average of 2 years
|
|
General disorders
Pain
|
47.2%
91/193 • Number of events 179 • Through study completation, an average of 2 years
|
46.1%
89/193 • Number of events 184 • Through study completation, an average of 2 years
|
|
General disorders
Pyrexia
|
24.9%
48/193 • Number of events 103 • Through study completation, an average of 2 years
|
20.2%
39/193 • Number of events 67 • Through study completation, an average of 2 years
|
|
General disorders
Oedema
|
13.5%
26/193 • Number of events 31 • Through study completation, an average of 2 years
|
13.0%
25/193 • Number of events 29 • Through study completation, an average of 2 years
|
|
General disorders
Mucosal inflammation
|
10.4%
20/193 • Number of events 29 • Through study completation, an average of 2 years
|
8.8%
17/193 • Number of events 23 • Through study completation, an average of 2 years
|
|
Psychiatric disorders
Insomnia
|
5.7%
11/193 • Number of events 12 • Through study completation, an average of 2 years
|
6.2%
12/193 • Number of events 12 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Nausea
|
31.6%
61/193 • Number of events 122 • Through study completation, an average of 2 years
|
32.1%
62/193 • Number of events 130 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Constipation
|
21.8%
42/193 • Number of events 65 • Through study completation, an average of 2 years
|
23.3%
45/193 • Number of events 65 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
33/193 • Number of events 61 • Through study completation, an average of 2 years
|
19.7%
38/193 • Number of events 81 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
20/193 • Number of events 39 • Through study completation, an average of 2 years
|
18.7%
36/193 • Number of events 58 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
10/193 • Number of events 12 • Through study completation, an average of 2 years
|
5.7%
11/193 • Number of events 13 • Through study completation, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
12/193 • Number of events 12 • Through study completation, an average of 2 years
|
2.1%
4/193 • Number of events 4 • Through study completation, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
11/193 • Number of events 15 • Through study completation, an average of 2 years
|
4.1%
8/193 • Number of events 8 • Through study completation, an average of 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
46/193 • Number of events 68 • Through study completation, an average of 2 years
|
26.4%
51/193 • Number of events 76 • Through study completation, an average of 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
12/193 • Number of events 21 • Through study completation, an average of 2 years
|
2.6%
5/193 • Number of events 6 • Through study completation, an average of 2 years
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
13/193 • Number of events 15 • Through study completation, an average of 2 years
|
5.2%
10/193 • Number of events 13 • Through study completation, an average of 2 years
|
|
Investigations
Transaminases Increased
|
7.3%
14/193 • Number of events 37 • Through study completation, an average of 2 years
|
3.6%
7/193 • Number of events 20 • Through study completation, an average of 2 years
|
|
Gastrointestinal disorders
Abdominal disconfort
|
0.52%
1/193 • Number of events 1 • Through study completation, an average of 2 years
|
5.7%
11/193 • Number of events 12 • Through study completation, an average of 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place