Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months. At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent. Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups: Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients). Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients). All the patients will be seen according to normal practice by the study medical team. Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.
Detailed description
Purpose: Study Design:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Male or female patient older than 18 years. Adult patient diagnosed with stage IIIb/IV NSCLC locally advanced or metastatic, with activating mutation(s) of EGFR and who is EGFR-TKI naïve. Patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization. Out-patient. Patient having given written consent for participation in the study. Patient who is able to participate in the investigator's opinion. Patient affiliated with the French social security.
Exclusion criteria
Patients participating in an interventional clinical study. Patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion. Patients participating in a therapeutic education program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up. | 3 months | The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team | 3 months | The cumulated dose (mg) of oral targeted therapy not taken between 2 visits is the sum of the doses (mg) of tablets not taken by the patient. The cumulated dose (mg) of oral targeted therapy not taken during the 3-month follow-up is the sum of the cumulated doses (mg) not taken between 2 visits during the 3-month follow-up. |
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team. | 3 months | Cumulated dose of oral targeted therapy not taken due to dose reduction following decision of the medical team. There were no participants with dose reduction hence the data is not available. |
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision. | 3 months | Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following the medical team decision. |
| Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision. | 3 months | Cumulated dose of oral targeted therapy not taken (all categories) following patient decision. Cumulated dose not taken in total is missing since no patient without therapy following patient decision |
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision. | 3 months | Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction. |
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision. | 3 months | Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision. No patient without therapy following patient decision |
| Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90. | 3 months | VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. |
| Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Day0 (D0), Day30 (D30) and Day90 (D90) | The patients' quality of life was evaluated with the FACT-L questionnaire. This questionnaire explores 4 dimensions of well-being: physical, social and emotional. These items are completed by 9 questions specific to lung cancer. Subscale scores are added to obtain total score. Scores obtained with this questionnaire range between 0 and 136. The higher the score the better the quality of life. |
| Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | Day30 (D30), Day60 (D60) and Day90 (D90) | Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented |
| Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D30, D60, D90 | Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented |
| Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up. | D30, D60 and D90 | Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented |
| Score (0-6) Obtained With the Girerd Questionnaire | at Day 30 (D30), Day 60 (D60) and Day 90 (D90) | Girerd questionnaire is a questionnaire composed of 6 binary questions (yes/no) and is used to assess treatment compliance. The final score obtained is the number of questions to which the patient responded yes. Thus, the score ranges from 0 to 6. A patient will be classified as: Good compliant with score = 0. Minor non-compliant with score = 1 or 2. Non-compliant with score \>2. |
| Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30, D60 and D90 | Number of participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented |
| Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30, D60 and D90 | Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented |
| VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90 | D90 | VAS score (0-10) for overall investigator satisfaction with the level of patient care at D90 (Overall investigator satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. |
| VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up) | D90 | VAS score (0-10) for overall general practitioner satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up) (Overall general practitioner satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. |
| VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up). | D90 | VAS score (0-10) for overall pharmacist satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up)(Overall pharmacist satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. |
| Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D30, D60 and D90 | Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented |
| Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D30, D60 and D90 | Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented |
| Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30, D60 and D90 | Number of calls made by the patients to their medical team during the 3-month follow-up is presented |
| Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30, D60 and D90 | Number of calls made by the medical team to their patient during the 3-month follow-up is presented |
| Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D30, D60, D90 | Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented |
| Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | up to 3 months | Number of participants with Adverse events AEs, of AEs of grade ≥ 3, of serious adverse events (SAEs) related to the oral biological therapy and Number of AEs related to the oral targeted therapy which causes temporary or definitive discontinuation of the treatment or dose reduction are presented |
| Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D30, D60 and D90 | Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented |
Countries
France
Participant flow
Recruitment details
The study was conducted in 14 French active centres and lasted 14 months. The recruitment phase was stopped after 10.7 months. Each patient participated for approximately 3 months. Actual subjects enrolled were 30 but two subjects are not included because of incomplete case record form (CRF)
Pre-assignment details
Patients for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization were included in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Group With Nurse-led Telephone Follow-up Group with remote additional personalised nurse-led follow-up: patients received telephone calls from a nurse in addition to the healthcare given routinely by their medical team | 21 |
| Group Without Nurse-led Telephone Follow-up Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team | 7 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other reason | 0 | 1 |
| Overall Study | Treatment stop | 3 | 0 |
Baseline characteristics
| Characteristic | Group With Nurse-led Telephone Follow-up | Group Without Nurse-led Telephone Follow-up | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 10.9 | 69.9 years STANDARD_DEVIATION 12.6 | 65.2 years STANDARD_DEVIATION 11.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 3 Participants | 19 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 7 | 0 / 28 |
| other Total, other adverse events | 21 / 21 | 6 / 7 | 27 / 28 |
| serious Total, serious adverse events | 2 / 21 | 1 / 7 | 3 / 28 |
Outcome results
Primary
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up. | 3120 milligram (mg) |
| Group Without Nurse-led Telephone Follow-up | The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up. | 3220.0 milligram (mg) |
Secondary
Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0
The patients' quality of life was evaluated with the FACT-L questionnaire. This questionnaire explores 4 dimensions of well-being: physical, social and emotional. These items are completed by 9 questions specific to lung cancer. Subscale scores are added to obtain total score. Scores obtained with this questionnaire range between 0 and 136. The higher the score the better the quality of life.
Time frame: Day0 (D0), Day30 (D30) and Day90 (D90)
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D30 and D0 | -4 scores on a scale |
| Group With Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D90 and D0 | -8 scores on a scale |
| Group With Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D90 and D30 | -2 scores on a scale |
| Group Without Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D30 and D0 | 1 scores on a scale |
| Group Without Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D90 and D0 | 4 scores on a scale |
| Group Without Nurse-led Telephone Follow-up | Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0 | Absolute variation between D90 and D30 | 0 scores on a scale |
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team
The cumulated dose (mg) of oral targeted therapy not taken between 2 visits is the sum of the doses (mg) of tablets not taken by the patient. The cumulated dose (mg) of oral targeted therapy not taken during the 3-month follow-up is the sum of the cumulated doses (mg) not taken between 2 visits during the 3-month follow-up.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team | 520 milligram (mg) |
| Group Without Nurse-led Telephone Follow-up | Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team | 420 milligram (mg) |
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.
Cumulated dose of oral targeted therapy not taken (all categories) following patient decision. Cumulated dose not taken in total is missing since no patient without therapy following patient decision
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.
Cumulated dose of oral targeted therapy not taken due to dose reduction following decision of the medical team. There were no participants with dose reduction hence the data is not available.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.
Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- only participants with dose reduction
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision. No patient without therapy following patient decision
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Unknown | Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision. | Temporary interruption | — milligram (mg) |
| Unknown | Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision. | Definitive interruption | — milligram (mg) |
Secondary
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following the medical team decision.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision. | Temporary interruption | 0.0 milligram (mg) |
Secondary
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up. | D30 | 13 days |
| Group With Nurse-led Telephone Follow-up | Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up. | D60 | 3 days |
| Group With Nurse-led Telephone Follow-up | Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up. | D90 | 14 days |
Secondary
Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction.
Number of participants with Adverse events AEs, of AEs of grade ≥ 3, of serious adverse events (SAEs) related to the oral biological therapy and Number of AEs related to the oral targeted therapy which causes temporary or definitive discontinuation of the treatment or dose reduction are presented
Time frame: up to 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | Adverse events (AEs) | 21 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | AEs of grade ≥3 | 6 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | SAEs related to oral biological therapy | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | AEs related to oral targeted therapy | 21 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | AEs related to oral targeted therapy | 6 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | Adverse events (AEs) | 6 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | SAEs related to oral biological therapy | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction. | AEs of grade ≥3 | 1 Participants |
Secondary
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented
Time frame: D30, D60, D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D30- no call | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D60- no call | 11 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D90- 1 call | 0 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D90- no call | 15 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D90- 1 call | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D30- no call | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D60- no call | 3 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | D90- no call | 4 Participants |
Secondary
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D30- no call | 15 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D60-no call | 15 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D90-no call | 14 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D30- no call | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D60-no call | 3 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | D90-no call | 4 Participants |
Secondary
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
Number of calls made by the medical team to their patient during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- no call | 10 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 1 call | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 2 calls | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 3 calls | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- no call | 11 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 1 call | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 2 calls | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 3 calls | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D90- no call | 14 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D90- 1 call | 2 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 3 calls | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- no call | 3 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 1 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 1 call | 2 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D90- 1 call | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 2 calls | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- 2 calls | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D30- 3 calls | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D90- no call | 4 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | D60- no call | 4 Participants |
Secondary
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60- no call | 12 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60-3 calls | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D30-1 call | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D90- no call | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60-1 call | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D90-1 call | 0 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D30- no call | 15 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D90-1 call | 2 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D30- no call | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D30-1 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60- no call | 3 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60-1 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D60-3 calls | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | D90- no call | 2 Participants |
Secondary
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
Number of calls made by the patients to their medical team during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- no call | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- 1 call | 4 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- 2 call | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- no call | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- 1 call | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- 2 call | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D90- no call | 15 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D90- 1 call | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D90- 1 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- no call | 4 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- 1 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- 1 call | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D90- no call | 4 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D30- 2 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- 2 call | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | D60- no call | 4 Participants |
Secondary
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented
Time frame: Day30 (D30), Day60 (D60) and Day90 (D90)
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D30- no admission | 18 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D30- 1 admission | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D60- no admission | 14 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D60- 1 admission | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D90- no admission | 17 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D90- 1 admission | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D90- no admission | 4 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D30- no admission | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D60- 1 admission | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D30- 1 admission | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D90- 1 admission | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | D60- no admission | 5 Participants |
Secondary
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented
Time frame: D30, D60, D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D30- no hospitalization | 18 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D30- 1 hospitalization | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D60- no hospitalization | 16 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D60- 1 hospitalization | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D90- no hospitalization | 16 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D90- 1 hospitalization | 2 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D90- no hospitalization | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D30- no hospitalization | 6 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D60- 1 hospitalization | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D30- 1 hospitalization | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D90- 1 hospitalization | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | D60- no hospitalization | 5 Participants |
Secondary
Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.
Number of participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- no visit | 14 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- 1 visit | 2 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- 3 visits | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D60- no visit | 16 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D60- 1 visit | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- no visit | 15 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- 1 visit | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- 2 visit | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- 2 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- no visit | 6 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D60- 1 visit | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D30- 3 visits | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D90- no visit | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up. | D60- no visit | 3 Participants |
Secondary
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- 2 visits | 1 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D60- 1 visit | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- 1 visit | 4 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D90- no visit | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D60- no visit | 13 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D90- 1 visit | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- no visit | 11 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D90- 1 visit | 2 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- no visit | 4 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- 1 visit | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D30- 2 visits | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D60- no visit | 3 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D60- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | D90- no visit | 3 Participants |
Secondary
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented
Time frame: D30, D60 and D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D30- no visit | 16 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D30- 1 visit | 3 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D60- no visit | 14 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D60- 1 visit | 4 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D90- no visit | 17 Participants |
| Group With Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D90- 1 visit | 1 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D90- no visit | 5 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D30- no visit | 6 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D60- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D30- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D90- 1 visit | 0 Participants |
| Group Without Nurse-led Telephone Follow-up | Number of Unplanned Visits to the Investigator During the 3-month Follow-up | D60- no visit | 5 Participants |
Secondary
Score (0-6) Obtained With the Girerd Questionnaire
Girerd questionnaire is a questionnaire composed of 6 binary questions (yes/no) and is used to assess treatment compliance. The final score obtained is the number of questions to which the patient responded yes. Thus, the score ranges from 0 to 6. A patient will be classified as: Good compliant with score = 0. Minor non-compliant with score = 1 or 2. Non-compliant with score \>2.
Time frame: at Day 30 (D30), Day 60 (D60) and Day 90 (D90)
Population: Population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group With Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D30 | 0.3 scores on a scale | Standard Deviation 0.6 |
| Group With Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D60 | 0.4 scores on a scale | Standard Deviation 0.6 |
| Group With Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D90 | 0.4 scores on a scale | Standard Deviation 0.6 |
| Group Without Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D30 | 0.0 scores on a scale | Standard Deviation 0 |
| Group Without Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D60 | 0.0 scores on a scale | Standard Deviation 0 |
| Group Without Nurse-led Telephone Follow-up | Score (0-6) Obtained With the Girerd Questionnaire | D90 | 0.2 scores on a scale | Standard Deviation 0.4 |
Secondary
VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up)
VAS score (0-10) for overall general practitioner satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up) (Overall general practitioner satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Time frame: D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up) | 8 scores on a scale |
Secondary
VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90
VAS score (0-10) for overall investigator satisfaction with the level of patient care at D90 (Overall investigator satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Time frame: D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90 | 8 scores on a scale |
| Group Without Nurse-led Telephone Follow-up | VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90 | 7 scores on a scale |
Secondary
VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up).
VAS score (0-10) for overall pharmacist satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up)(Overall pharmacist satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Time frame: D90
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up). | 9 scores on a scale |
Secondary
Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.
VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Time frame: 3 months
Population: The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group With Nurse-led Telephone Follow-up | Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90. | 9 scores on a scale |
| Group Without Nurse-led Telephone Follow-up | Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90. | 10 scores on a scale |