Breakthrough Pain, Cancer
Conditions
Keywords
intranasal fentanyl spray
Brief summary
The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
Interventions
DRUGInstanyl (Intranasal Fentanyl)
This was an observational study. Therefore, the physician decided about dosage according to individual needs.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* decision to start treatment with intranasal fentanyl spray * written informed consent
Exclusion criteria
* criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Instanyl | during therapy with Instanyl (planned: 28 days) | Initially prescribed dose/ most efficient single dose of Instanyl at study end |
| Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | before and after therapy with Instanyl (first/last visit) | Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme |
| Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | before and after therapy with Instanyl (first/last visit) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient |
| Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) | after therapy with Instanyl (planned: 4 weeks) | 5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all |
| Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | after therapy with Instanyl (at last visit) | Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened |
| Physician: What is the Current Treatment Needs of Your Patient Regarding ... | before and after therapy with Instanyl (first/last visit) | Scale: 0=no, 1=low, 2=medium, 3=high |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) | before and after therapy with Instanyl (first/last visit) | Scale: 0=complete impairment, 43=no impairment |
| Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | before and after therapy with Instanyl (first/last visit) | 0= conspicuous ≤20 1= inconspicuous \>20 |
| Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) | before and after therapy with Instanyl (first/last visit) | Scale: 0=worst, 5=best |
| Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | before and after therapy with Instanyl (first/last visit) | conspicuous score \<1.5 inconspicuous score ≥1.5 |
| Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | after therapy with Instanyl (planned: 4 weeks) | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete |
| Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | before and after therapy with Instanyl (first/last visit) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient |
| Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | after therapy with Instanyl (planned: 4 weeks) | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete |
| Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | after therapy with Instanyl (at last visit) | Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened |
| Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End | after therapy with Instanyl (planned: 4 weeks) | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete |
| Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | after therapy with Instanyl (first/last visit) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient |
| Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | after therapy with Instanyl (at last visit) | Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened |
| Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | after therapy with Instanyl (last visit) | Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more |
| Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | after therapy with Instanyl (planned: 4 weeks) | 5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all |
| Patient: How Many Episodes of Pain You Experience on Average? | initial visit (before start of therapy with Instanyl) | — |
| Patient: Description of Pain at Initial Visit | initial visit (before start of therapy with Instanyl) | 0=no pain, 10= most intense pain imaginable |
| Patient: How do You Feel Today? | before and after therapy with Instanyl (first/last visit) | Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good |
| Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? | before and after therapy with Instanyl (first/last visit) | Scale: 0=not at all, 10=completely |
| Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) | before and after therapy with Instanyl (first/last visit) | Scale: 0=no impairment, 70=complete impairment |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GENISIS Intranasal Fentanyl Spray | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | GENISIS |
|---|---|
| Age Continuous | 62.1 years STANDARD_DEVIATION 12.1 |
| American Society of Anesthesiologists (ASA)-physical state (2-5) ASA 2 | 22 participants |
| American Society of Anesthesiologists (ASA)-physical state (2-5) ASA 3 | 40 participants |
| American Society of Anesthesiologists (ASA)-physical state (2-5) ASA 4 | 59 participants |
| American Society of Anesthesiologists (ASA)-physical state (2-5) ASA 5 | 5 participants |
| American Society of Anesthesiologists (ASA)-physical state (2-5) Missing | 5 participants |
| Body Mass Index (BMI) | 23.2 kgˆm2 STANDARD_DEVIATION 4.4 |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) ECOG 0 | 2 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) ECOG 1 | 33 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) ECOG 2 | 40 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) ECOG 3 | 36 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) ECOG 4 | 14 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status (0-4) Missing | 6 participants |
| Karnofsky-index | 58.6 scores STANDARD_DEVIATION 21.6 |
| Reason for the use of Instanyl No previous BTP medication | 86 participants |
| Reason for the use of Instanyl Previous BTP medic./Insufficient efficacy | 32 participants |
| Reason for the use of Instanyl Previous BTP medic./Insufficient handling | 12 participants |
| Reason for the use of Instanyl Previous BTP medic./Insufficient speed of action | 32 participants |
| Reason for the use of Instanyl Previous BTP medic./Insufficient tolerability | 6 participants |
| Reason for the use of Instanyl Previous BTP medic./Other reasons | 7 participants |
| Sex/Gender, Customized Female | 60 participants |
| Sex/Gender, Customized Male | 67 participants |
| Sex/Gender, Customized Missing | 4 participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C00-C14 lip, oral cavity and pharynx | 6.1 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C15-C26 digestive organs | 26.0 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C30-C39 respiratory and intrathoracic organs | 16.0 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C40-C41 bone and articular cartilage | 0.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C43-C44 Melanoma and other skin | 0.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C50-C50 Mamma | 20.6 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C51-C58 female genital organs | 3.1 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C60-C63 male genital organs | 13.0 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C64-C68 urinary tract | 5.3 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C73-C75 thyroid and other endocrine glands | 0.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C76-C80 ill-defined, secondary + unspecified sites | 0.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) C81-C96 lymphoid, hematopoietic and related tissue | 0.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) Missing | 3.8 percentage of participants |
| Tumor diagnosis (malignant neop-lasms ICD10) Pain not caused by tumor | 2.3 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 131 |
| serious Total, serious adverse events | 19 / 131 |
Outcome results
Primary
Dose of Instanyl
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Time frame: during therapy with Instanyl (planned: 28 days)
Population: Patients included and treated (without imputation of missing values), intention to treat.~All patients included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Start | Dose of Instanyl | 100 µg | 50 participants |
| Study Start | Dose of Instanyl | 400 µg | 0 participants |
| Study Start | Dose of Instanyl | 200 µg | 5 participants |
| Study Start | Dose of Instanyl | Missing | 1 participants |
| Study Start | Dose of Instanyl | 50 µg | 75 participants |
| Study End | Dose of Instanyl | Missing | 1 participants |
| Study End | Dose of Instanyl | 50 µg | 30 participants |
| Study End | Dose of Instanyl | 100 µg | 69 participants |
| Study End | Dose of Instanyl | 200 µg | 15 participants |
| Study End | Dose of Instanyl | 400 µg | 1 participants |
Primary
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed')= N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | speed of action (FV: N= 45, LV: N= 114) | 4.0 units on a scale | Standard Deviation 1.3 |
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | strength of action (FV: N= 45, LV: N= 115) | 4.0 units on a scale | Standard Deviation 1.3 |
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | tolerability (FV: N= 44, LV: N= 113) | 3.0 units on a scale | Standard Deviation 1.4 |
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | safety (FV: N= 45, LV: N= 114) | 2.9 units on a scale | Standard Deviation 1.2 |
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | handling (FV: N= 45, LV: N= 115) | 3.4 units on a scale | Standard Deviation 1.4 |
| Study Start | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | patient satisfaction (FV: N= 45, LV: N= 116) | 4.2 units on a scale | Standard Deviation 1.3 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | handling (FV: N= 45, LV: N= 115) | 2.1 units on a scale | Standard Deviation 1.2 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | speed of action (FV: N= 45, LV: N= 114) | 1.7 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | safety (FV: N= 45, LV: N= 114) | 1.7 units on a scale | Standard Deviation 0.6 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | strength of action (FV: N= 45, LV: N= 115) | 1.8 units on a scale | Standard Deviation 0.9 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | patient satisfaction (FV: N= 45, LV: N= 116) | 1.9 units on a scale | Standard Deviation 1.1 |
| Study End | Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | tolerability (FV: N= 44, LV: N= 113) | 1.7 units on a scale | Standard Deviation 0.6 |
Primary
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | Breakthrough pain (IV: N= 126, LV: N= 115) | 3.5 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | Persistent pain (IV: N= 126, LV: N= 116) | 2.3 units on a scale | Standard Deviation 1.1 |
| Study End | Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | Breakthrough pain (IV: N= 126, LV: N= 115) | 1.8 units on a scale | Standard Deviation 1.2 |
| Study End | Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | Persistent pain (IV: N= 126, LV: N= 116) | 1.6 units on a scale | Standard Deviation 0.9 |
Primary
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Population: All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N=number of valid cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Nursing and support efforts (N= 113) | -1.2 units on a scale | Standard Deviation 1 |
| Study Start | Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Autonomy of the patient (N= 113) | -1.5 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Pain-related impairment in everyday life (N= 113) | -1.6 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Quality of patient's life (N= 112) | -1.5 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Extent of use of other medical services (N= 112) | -1.1 units on a scale | Standard Deviation 1 |
Primary
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Time frame: after therapy with Instanyl (planned: 4 weeks)
Population: Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) | 4.4 units on a scale | Standard Deviation 0.7 |
Primary
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Scale: 0=no, 1=low, 2=medium, 3=high
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | Overburdening family/environment N=129, N=112 | 1.4 units on a scale | Standard Deviation 1 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | dyspnoea (IV: N=130, LV: N=111) | 1.0 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | disorientation, confusion (IV: N=130, LV: N=111) | 0.6 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | constipation (IV: N=129, LV: N=112) | 1.2 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | tension (IV: N=130, LV: N=112) | 1.6 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | weakness (IV: N=129, LV: N=112) | 2.0 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | breakthrough pain (IV: N=130, LV: N=111) | 2.5 units on a scale | Standard Deviation 0.6 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | poor appetite (IV: N=131, LV: N=112) | 1.8 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | Problems with organization of care (N=129, N=112) | 1.1 units on a scale | Standard Deviation 1 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | tiredness (IV: N=130, LV: N=112) | 1.8 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | nausea (IV: N=130, LV: N=112) | 1.5 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | efforts due to wounds/decubitus (N=130, N=112) | 1.0 units on a scale | Standard Deviation 1 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | anxiety (IV: N=130, LV: N=112) | 1.6 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | need for assistance (IV: N=130, LV: N=111) | 1.8 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | vomiting (IV: N=130, LV: N=112) | 1.2 units on a scale | Standard Deviation 0.9 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | depressiveness (IV: N=129, LV: N=111) | 1.6 units on a scale | Standard Deviation 0.8 |
| Study Start | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | persistent pain (IV: N=131, LV: N=112) | 2.0 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | depressiveness (IV: N=129, LV: N=111) | 1.1 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | anxiety (IV: N=130, LV: N=112) | 1.1 units on a scale | Standard Deviation 0.7 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | tension (IV: N=130, LV: N=112) | 1.2 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | disorientation, confusion (IV: N=130, LV: N=111) | 0.5 units on a scale | Standard Deviation 0.7 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | Problems with organization of care (N=129, N=112) | 0.8 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | Overburdening family/environment N=129, N=112 | 1.0 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | persistent pain (IV: N=131, LV: N=112) | 1.3 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | breakthrough pain (IV: N=130, LV: N=111) | 1.2 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | nausea (IV: N=130, LV: N=112) | 0.9 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | vomiting (IV: N=130, LV: N=112) | 0.7 units on a scale | Standard Deviation 0.7 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | dyspnoea (IV: N=130, LV: N=111) | 0.7 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | constipation (IV: N=129, LV: N=112) | 0.8 units on a scale | Standard Deviation 0.8 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | weakness (IV: N=129, LV: N=112) | 1.4 units on a scale | Standard Deviation 1 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | poor appetite (IV: N=131, LV: N=112) | 1.4 units on a scale | Standard Deviation 1 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | tiredness (IV: N=130, LV: N=112) | 1.4 units on a scale | Standard Deviation 0.9 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | efforts due to wounds/decubitus (N=130, N=112) | 0.8 units on a scale | Standard Deviation 0.9 |
| Study End | Physician: What is the Current Treatment Needs of Your Patient Regarding ... | need for assistance (IV: N=130, LV: N=111) | 1.3 units on a scale | Standard Deviation 0.9 |
Secondary
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: after therapy with Instanyl (first/last visit)
Population: Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.~All patients with valid values ('as observed'). N= number of valid cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | handling (N=69) | 2.2 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | patient satisfaction (N=68) | 2.1 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | speed of action (N=69) | 2.2 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | strength of action (N=69) | 2.1 units on a scale | Standard Deviation 0.9 |
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | tolerability (N=69) | 1.9 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | safety (N=68) | 2.0 units on a scale | Standard Deviation 0.8 |
Secondary
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End | 3.3 units on a scale | Standard Deviation 1 |
Secondary
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed') =N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Nursing and support efforts (N= 69) | -0.8 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Autonomy of the patient (N= 69) | -1.2 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Pain-related impairment in everyday life (N= 69) | -1.3 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Quality of patient's life (N= 68) | -1.3 units on a scale | Standard Deviation 0.7 |
| Study Start | Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Extent of use of other medical services (N= 69) | -0.9 units on a scale | Standard Deviation 0.8 |
Secondary
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
Time frame: after therapy with Instanyl (last visit)
Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed'). N= number of valid cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | persistent pain (N=68) | -1.2 units on a scale | Standard Deviation 0.9 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | breakthrough pain (N=68) | -1.8 units on a scale | Standard Deviation 0.8 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | nausea (N=68) | -1.1 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | vomiting (N=65) | -0.9 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | dyspnoea (N=66) | -1.1 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | constipation (N=68) | -0.8 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | weakness (N=68) | -0.7 units on a scale | Standard Deviation 0.9 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | poor appetite (N=68) | -0.7 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | tiredness (N=67) | -0.8 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | efforts due to wounds/decubitus (N=68) | -0.8 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | need for assistance in daily activities (N=68) | -1.1 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | depressiveness (N=67) | -1.0 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | anxiety (N=67) | -1.2 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | tension (N=67) | -1.1 units on a scale | Standard Deviation 1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | disorientation, confusion (N=67) | -0.9 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | Problems with the organization of care (N=68) | -1.0 units on a scale | Standard Deviation 1.1 |
| Study Start | Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | Overburdening family/environment (N=68) | -1.2 units on a scale | Standard Deviation 1.1 |
Secondary
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed').
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | speed of action (FV: N=33, LV: N=82) | 4.1 units on a scale | Standard Deviation 1.1 |
| Study Start | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | handling (FV: N=33, LV: N=80) | 3.4 units on a scale | Standard Deviation 1.3 |
| Study Start | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | strength of action (FV: N=33, LV: N=82) | 3.9 units on a scale | Standard Deviation 1.2 |
| Study Start | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | total satisfaction (FV: N=NA, LV: N=82) | NA units on a scale | — |
| Study Start | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | tolerability (FV: N=33, LV: N=82) | 3.2 units on a scale | Standard Deviation 1.1 |
| Study End | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | total satisfaction (FV: N=NA, LV: N=82) | 2.0 units on a scale | Standard Deviation 1.1 |
| Study End | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | speed of action (FV: N=33, LV: N=82) | 2.0 units on a scale | Standard Deviation 1 |
| Study End | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | tolerability (FV: N=33, LV: N=82) | 2.0 units on a scale | Standard Deviation 1.1 |
| Study End | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | handling (FV: N=33, LV: N=80) | 2.0 units on a scale | Standard Deviation 1 |
| Study End | Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | strength of action (FV: N=33, LV: N=82) | 2.0 units on a scale | Standard Deviation 1.1 |
Secondary
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
Population: Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | 3.4 units on a scale | Standard Deviation 1 |
Secondary
Patient: Description of Pain at Initial Visit
0=no pain, 10= most intense pain imaginable
Time frame: initial visit (before start of therapy with Instanyl)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed') =N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Patient: Description of Pain at Initial Visit | Persistent pain in the last 24 hrs on average N=94 | 5.6 units on a scale | Standard Deviation 2.3 |
| Study Start | Patient: Description of Pain at Initial Visit | Pain during the last pain attacks maximally N=93 | 8.3 units on a scale | Standard Deviation 1.4 |
| Study Start | Patient: Description of Pain at Initial Visit | Pain intensity bearable N= 94 | 4.0 units on a scale | Standard Deviation 1.5 |
Secondary
Patient: How do You Feel Today?
Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~* Initial Visit N=94~* Last Visit N=83
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: How do You Feel Today? | 2.2 units on a scale | Standard Deviation 0.7 |
| Study End | Patient: How do You Feel Today? | 3.3 units on a scale | Standard Deviation 0.8 |
Secondary
Patient: How Many Episodes of Pain You Experience on Average?
Time frame: initial visit (before start of therapy with Instanyl)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: How Many Episodes of Pain You Experience on Average? | 3.0 episodes per day | Standard Deviation 2.2 |
Secondary
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
Scale: 0=worst, 5=best
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~* Initial Visit N=93~* Last Visit N=81
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) | 1.2 units on a scale | Standard Deviation 1 |
| Study End | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) | 2.2 units on a scale | Standard Deviation 1.2 |
Secondary
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
conspicuous score \<1.5 inconspicuous score ≥1.5
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Start | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | MQHH - score (classified):conspicuous:score <1.5 | 62 participants |
| Study Start | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | MQHH - score (classified):inconspicuous:score ≥1.5 | 31 participants |
| Study Start | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | Missing | 2 participants |
| Study End | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | MQHH - score (classified):conspicuous:score <1.5 | 24 participants |
| Study End | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | MQHH - score (classified):inconspicuous:score ≥1.5 | 57 participants |
| Study End | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | Missing | 2 participants |
Secondary
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
Scale: 0=no impairment, 70=complete impairment
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~* Initial Visit N=92~* Last Visit N= 80
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) | 51.9 units on a scale | Standard Deviation 11.4 |
| Study End | Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) | 29.1 units on a scale | Standard Deviation 16.3 |
Secondary
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
Scale: 0=complete impairment, 43=no impairment
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~* Initial Visit N=93~* Last Visit N=82
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) | 12.3 units on a scale | Standard Deviation 6.6 |
| Study End | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) | 24.7 units on a scale | Standard Deviation 7.3 |
Secondary
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
0= conspicuous ≤20 1= inconspicuous \>20
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Start | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | QLIP - score (classified):QLIP conspicuous (≤20) | 80 participants |
| Study Start | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | QLIP - score (classified):QLIP inconspicuous (>20) | 13 participants |
| Study Start | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | Missing | 2 participants |
| Study End | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | QLIP - score (classified):QLIP conspicuous (≤20) | 21 participants |
| Study End | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | QLIP - score (classified):QLIP inconspicuous (>20) | 61 participants |
| Study End | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | Missing | 1 participants |
Secondary
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | Nursing and support efforts (N= 81) | -1.0 units on a scale | Standard Deviation 0.9 |
| Study Start | Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | Autonomy of the patient (N= 81) | -1.4 units on a scale | Standard Deviation 0.8 |
| Study Start | Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | Pain-related impairment in everyday life (N= 81) | -1.3 units on a scale | Standard Deviation 0.8 |
| Study Start | Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | Quality of patient's life (N= 81) | -1.4 units on a scale | Standard Deviation 0.8 |
Secondary
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
Time frame: after therapy with Instanyl (planned: 4 weeks)
Population: Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Start | Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | tolerability (N=78) | 4.3 units on a scale | Standard Deviation 0.7 |
| Study Start | Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | speed of action (N=79) | 4.2 units on a scale | Standard Deviation 0.8 |
| Study Start | Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | strength of action (N=80) | 4.2 units on a scale | Standard Deviation 0.9 |
| Study Start | Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | handling (N=79) | 4.2 units on a scale | Standard Deviation 0.9 |
| Study Start | Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | total satisfaction (N=80) | 4.2 units on a scale | Standard Deviation 0.9 |
Secondary
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
Scale: 0=not at all, 10=completely
Time frame: before and after therapy with Instanyl (first/last visit)
Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~* Initial Visit N=94~* Last Visit N=83
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? | 7.6 units on a scale | Standard Deviation 1.7 |
| Study End | Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? | 3.8 units on a scale | Standard Deviation 2.3 |
Secondary
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
Population: Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Start | Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | 3.4 units on a scale | Standard Deviation 1 |