| 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. | 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 | Posted | | Median | Full Range | milligram (mg) | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003120(2350 to 3680)
- OG0013220.0(3080 to 3360)
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| 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. | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | at Day 30 (D30), Day 60 (D60) and Day 90 (D90) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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 | Posted | | Median | Full Range | milligram (mg) | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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 | Posted | | | | | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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 | Posted | | Mean | Standard Deviation | milligram (mg) | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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 | Posted | | | | | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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 | Posted | | | | | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Mean | Standard Deviation | milligram (mg) | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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) | Posted | | Median | Full Range | scores on a scale | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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) | Posted | | Median | Full Range | scores on a scale | | Day0 (D0), Day30 (D30) and Day90 (D90) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Number | | Participants | | Day30 (D30), Day60 (D60) and Day90 (D90) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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 | Posted | | Number | | Participants | | D30, D60, D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Median | Full Range | days | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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) | Posted | | Median | Full Range | scores on a scale | | D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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) | Posted | | Median | Full Range | scores on a scale | | D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Group Without Nurse-led Telephone Follow-up | |
|
| 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. | 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) | Posted | | Median | Full Range | scores on a scale | | D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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 | 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) | Posted | | Number | | Participants | | D30, D60 and D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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 | Posted | | Number | | Participants | | D30, D60, D90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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 | Posted | | Number | | Participants | | up to 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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