Evaluation of Medical Care Utilization in the Two Treatment Arms
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed · Source last updated 2019-09-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessed every 6-12 weeks, up to 100 weeks
What was measured
Medical 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.
Groups in this outcome
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)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
A: NGR-hTNF + BIC
200
B: Placebo+BIC
200
Reported measurements
ACE INHIBITORS, COMBINATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ACE INHIBITORS, PLAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
5
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ADRENERGICS, INHALANTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
10
Not reported
Not reported
Not reported
Not reported
AMINOGLYCOSIDE ANTIBACTERIALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANESTHETICS, LOCAL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
ANGIOTENSIN II ANTAGONISTS,COMBINATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
ANGIOTENSIN II ANTAGONISTS, plain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
ANTACIDS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
13
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
7
Not reported
Not reported
Not reported
Not reported
ANTIADRENERGIC AGENTS CENTRALLY ACTING
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIADRENERGIC AGENTS PERIPHERALLY ACTING
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIANDROGENS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANTIARRHYTHMICS, CLASS I AND III
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
ANTIBIOTICS FOR TOPICAL USE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
ANTIDEPRESSANTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
17
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIDIARRHEAL MICROORGANISMS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANTIEMETICS AND ANTINAUSEANTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
107
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
110
Not reported
Not reported
Not reported
Not reported
ANTIEPILEPTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIFIBRINOLYTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
ANTIFUNGALS FOR TOPICAL USE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
ANTIGLAUCOMA PREPARATIONS AND MIOTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANTIGOUT PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
10
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
12
Not reported
Not reported
Not reported
Not reported
ANTIHISTAMINES FOR SYSTEMIC USE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
66
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
31
Not reported
Not reported
Not reported
Not reported
ANTIINFECTIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIINFLAMMATORY ANANTIRHEUMATIC PRODUCTSD
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
58
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
65
Not reported
Not reported
Not reported
Not reported
ANTIMETABOLITES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANTIMYCOTICS FOR SYSTEMIC USE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
15
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
14
Not reported
Not reported
Not reported
Not reported
ANTIPROPULSIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
8
Not reported
Not reported
Not reported
Not reported
ANTIPRURITICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
ANTIPSYCHOTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
ANTITHROMBOTIC AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
41
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
42
Not reported
Not reported
Not reported
Not reported
ANTIVERTIGO PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ANXIOLYTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
24
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
16
Not reported
Not reported
Not reported
Not reported
ASCORBIC ACID (VITAMIN C)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
BACTERIAL VACCINES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
BELLADONNA AND DERIVATIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
BETA BLOCKING AGENTS AND OTHER ANTIHYPERTENSIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
11
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
15
Not reported
Not reported
Not reported
Not reported
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
38
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
29
Not reported
Not reported
Not reported
Not reported
BILE THERAPY
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
BLOOD AND RELATED PRODUCTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
21
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
26
Not reported
Not reported
Not reported
Not reported
BLOOD GLUCOSE LOWERING DRUGS EXCL. INSULINS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
6
Not reported
Not reported
Not reported
Not reported
CALCIUM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
19
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
12
Not reported
Not reported
Not reported
Not reported
CAPILLARY STABILIZING
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
CARDIAC GLYCOSIDES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
CARDIAC STIMULANTS EXCL CARDIAC GLYCOSIDES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
138
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
108
Not reported
Not reported
Not reported
Not reported
CORTICOSTEROIDS, PLAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
COUGH SUPPRESSANTS AND EXPECTORANTS, COMBINATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPEC
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
17
Not reported
Not reported
Not reported
Not reported
DECONGESTANTS AND ANTIALLERGICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
DIRECT ACTING ANTIVIRALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
DIURETICS AND POTASSIUM-SPARING AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
6
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
DRUGS AFFECTING BONE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
DRUGS FOR CONSTIPATION
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
39
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
63
Not reported
Not reported
Not reported
Not reported
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REF
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
74
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
71
Not reported
Not reported
Not reported
Not reported
DRUGS FOR TREATMENT OF TUBERCULOSIS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
ECTOPARASITICIDES, INC SCABICIDESL.
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
EMOLLIENTS AND PROTECTIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
EXPECTORANTS EXCL COMBINATIONS WITH COUGH SUPPR.
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
14
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
9
Not reported
Not reported
Not reported
Not reported
HIGH-CEILING DIURETICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
19
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
20
Not reported
Not reported
Not reported
Not reported
HORMONES AND RELATED AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
HYPNOTICS AND SEDATIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
14
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
14
Not reported
Not reported
Not reported
Not reported
HYPOTHALAMIC HORMONES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
I.V. SOLUTION ADDITIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
17
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
21
Not reported
Not reported
Not reported
Not reported
I.V. SOLUTIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
6
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
10
Not reported
Not reported
Not reported
Not reported
IMMUNOSTIMULANTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
20
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
19
Not reported
Not reported
Not reported
Not reported
INSULINS AND ANALOGUES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
5
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
INTESTINAL ANTIINFECTIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
IRON PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
14
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
9
Not reported
Not reported
Not reported
Not reported
LIPID MODIFYING AGENTS, PLAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
LOW-CEILING DIURETICS, EXCL THIAZIDES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
8
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
14
Not reported
Not reported
Not reported
Not reported
MULTIVITAMINS, COMBINATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
MULTIVITAMINS, PLAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
MYDRIATICS AND CYCLOPLEGICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
OPIOIDS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
135
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
160
Not reported
Not reported
Not reported
Not reported
OTHER ANALGESICS AND ANTIPYRETICSD
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
105
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
93
Not reported
Not reported
Not reported
Not reported
OTHER ANTIANEMIC PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
20
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
20
Not reported
Not reported
Not reported
Not reported
OTHER ANTIBACTERIALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
OTHER ANTIDIARRHEALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
OTHER ANTINEOPLASTIC AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
OTHER BETA-LACTAM ANTIBACTERIALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
8
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
9
Not reported
Not reported
Not reported
Not reported
OTHER CARDIAC PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
OTHER DRUGS FOR ACID RELATED DISORDERS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
OTHER DRUGS FOR OBSTRUCTIVE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
8
Not reported
Not reported
Not reported
Not reported
OTHER MINERAL SUPPLEMENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
OTHER NUTRIENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
7
Not reported
Not reported
Not reported
Not reported
OTHER OPHTHALMOLOGICALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
OTHER PLAIN VITAMIN PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
OTHER RESPIRATORY SYSTEM PRODUCTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEA
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
OTHER VITAMIN PRODUCTS, COMBINATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
PERIPHERAL VASODILATORS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
POTASSIUM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
4
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
POTASSIUM-SPARING AGENTS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
PROPULSIVES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
68
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
87
Not reported
Not reported
Not reported
Not reported
PSYCHOLEPTICS AND PSYCHOANALEPTICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
PSYCHOSTIMULANTS,
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
QUINOLONE ANTIBACTERIALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
31
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
36
Not reported
Not reported
Not reported
Not reported
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VA
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
6
Not reported
Not reported
Not reported
Not reported
STOMATOLOGICAL PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
20
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
19
Not reported
Not reported
Not reported
Not reported
SULFONAMIDES AND TRIMETHOPRIM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
TETRACYCLINES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
THYROID PREPARATIONS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
2
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
UROLOGICALS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
1
Not reported
Not reported
Not reported
Not reported
VASODILATORS USED IN CARDIAC DISEASES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
2
Not reported
Not reported
Not reported
Not reported
VIRAL VACCINES
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
0
Not reported
Not reported
Not reported
Not reported
VITAMIN A AND D
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
5
Not reported
Not reported
Not reported
Not reported
VITAMIN B1, PLAIN AND IN COMBINATION WITH VITAMIN
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
0
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
VITAMIN B12 AND FOLIC ACID
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
7
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
11
Not reported
Not reported
Not reported
Not reported
VITAMIN K AND OTHER HEMOSTATICS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
1
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
3
Not reported
Not reported
Not reported
Not reported
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CA
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
A: NGR-hTNF + BIC
3
Not reported
Not reported
Not reported
Not reported
B: Placebo+BIC
4
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
ACE INHIBITORS, COMBINATIONS
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
title
ACE INHIBITORS, PLAIN
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
10
title
ADRENERGICS, INHALANTS
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
AMINOGLYCOSIDE ANTIBACTERIALS
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
title
ANESTHETICS, LOCAL
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
title
ANGIOTENSIN II ANTAGONISTS,COMBINATIONS
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
5
title
ANGIOTENSIN II ANTAGONISTS, plain
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
3
title
ANTACIDS
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
7
title
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
ANTIADRENERGIC AGENTS CENTRALLY ACTING
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
ANTIADRENERGIC AGENTS PERIPHERALLY ACTING
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
ANTIANDROGENS
denoms
counts
group Id
OG000
value
200
group Id
OG001
value
200
units
Participants
description
Medical 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.
groups
description
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)
id
OG000
title
A: NGR-hTNF + BIC
description
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)
id
OG001
title
B: Placebo+BIC
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Assessed every 6-12 weeks, up to 100 weeks
title
Evaluation of Medical Care Utilization in the Two Treatment Arms
Triangle