Trial Outcomes & Findings for Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance (NCT NCT02483416)
NCT ID: NCT02483416
Last Updated: 2019-03-01
Results Overview
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.
TERMINATED
30 participants
3 months
2019-03-01
Participant Flow
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)
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
7
|
|
Overall Study
COMPLETED
|
18
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Other reason
|
0
|
1
|
|
Overall Study
Treatment stop
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
69.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 11.4 • n=28 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=21 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=21 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=5 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=2 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
|
3120 milligram (mg)
Interval 2350.0 to 3680.0
|
3220.0 milligram (mg)
Interval 3080.0 to 3360.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Score (0-6) Obtained With the Girerd Questionnaire
D30
|
0.3 scores on a scale
Standard Deviation 0.6
|
0.0 scores on a scale
Standard Deviation 0.0
|
|
Score (0-6) Obtained With the Girerd Questionnaire
D60
|
0.4 scores on a scale
Standard Deviation 0.6
|
0.0 scores on a scale
Standard Deviation 0.0
|
|
Score (0-6) Obtained With the Girerd Questionnaire
D90
|
0.4 scores on a scale
Standard Deviation 0.6
|
0.2 scores on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=4 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=2 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team
|
520 milligram (mg)
Interval 0.0 to 800.0
|
420 milligram (mg)
Interval 80.0 to 760.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following the medical team decision.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
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)
Standard Deviation NA
As only 1 participant hence the standard deviation is not available
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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)
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision. No patient without therapy following patient decision
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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)
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=15 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=5 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
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
Interval 2.0 to 10.0
|
10 scores on a scale
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
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
Interval -41.0 to 14.0
|
1 scores on a scale
Interval -8.0 to 60.0
|
|
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
Interval -31.0 to 18.0
|
4 scores on a scale
Interval -3.0 to 54.0
|
|
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
Interval -31.0 to 27.0
|
0 scores on a scale
Interval -7.0 to 6.0
|
SECONDARY outcome
Timeframe: 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)
Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D30- 1 admission
|
1 Participants
|
1 Participants
|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D60- no admission
|
14 Participants
|
5 Participants
|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D60- 1 admission
|
3 Participants
|
0 Participants
|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D90- no admission
|
17 Participants
|
4 Participants
|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D90- 1 admission
|
1 Participants
|
1 Participants
|
|
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
D30- no admission
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: D30, D60, D90Population: 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
Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D30- no hospitalization
|
18 Participants
|
6 Participants
|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D30- 1 hospitalization
|
1 Participants
|
0 Participants
|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D60- no hospitalization
|
16 Participants
|
5 Participants
|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D60- 1 hospitalization
|
2 Participants
|
0 Participants
|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D90- no hospitalization
|
16 Participants
|
5 Participants
|
|
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
D90- 1 hospitalization
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
D30
|
13 days
Interval 13.0 to 13.0
|
—
|
|
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
D60
|
3 days
Interval 3.0 to 3.0
|
—
|
|
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
D90
|
14 days
Interval 4.0 to 23.0
|
—
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D90- 1 visit
|
1 Participants
|
0 Participants
|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D30- no visit
|
16 Participants
|
6 Participants
|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D30- 1 visit
|
3 Participants
|
0 Participants
|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D60- no visit
|
14 Participants
|
5 Participants
|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D60- 1 visit
|
4 Participants
|
0 Participants
|
|
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
D90- no visit
|
17 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
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
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
1 Participants
|
|
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
|
5 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D30- no visit
|
11 Participants
|
4 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D30- 1 visit
|
4 Participants
|
1 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D30- 2 visits
|
1 Participants
|
0 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D60- no visit
|
13 Participants
|
3 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D60- 1 visit
|
3 Participants
|
0 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D90- no visit
|
13 Participants
|
3 Participants
|
|
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
D90- 1 visit
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: D90Population: 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)
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=20 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=6 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90
|
8 scores on a scale
Interval 1.0 to 10.0
|
7 scores on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: D90Population: 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)
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=1 Participants
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
|
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
|
|---|---|---|
|
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
Interval 8.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: D90Population: 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)
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.
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=1 Participants
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
|
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
|
|---|---|---|
|
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
Interval 9.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D30- no call
|
15 Participants
|
5 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D30-1 call
|
1 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D60- no call
|
12 Participants
|
3 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D60-1 call
|
1 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D60-3 calls
|
1 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D90- no call
|
13 Participants
|
2 Participants
|
|
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
D90-1 call
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
D30- no call
|
15 Participants
|
5 Participants
|
|
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
D60-no call
|
15 Participants
|
3 Participants
|
|
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
D90-no call
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of calls made by the patients to their medical team during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D30- no call
|
13 Participants
|
4 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D30- 1 call
|
4 Participants
|
1 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D30- 2 call
|
2 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D60- no call
|
13 Participants
|
4 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D60- 1 call
|
3 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D60- 2 call
|
1 Participants
|
0 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D90- no call
|
15 Participants
|
4 Participants
|
|
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
D90- 1 call
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: D30, D60 and D90Population: 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)
Number of calls made by the medical team to their patient during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D30- no call
|
10 Participants
|
3 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D30- 1 call
|
2 Participants
|
2 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D30- 2 calls
|
2 Participants
|
0 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D30- 3 calls
|
2 Participants
|
0 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D60- no call
|
11 Participants
|
4 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D60- 1 call
|
3 Participants
|
0 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D60- 2 calls
|
1 Participants
|
0 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D60- 3 calls
|
2 Participants
|
0 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D90- no call
|
14 Participants
|
4 Participants
|
|
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
D90- 1 call
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: D30, D60, D90Population: 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
Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
D30- no call
|
13 Participants
|
5 Participants
|
|
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
D60- no call
|
11 Participants
|
3 Participants
|
|
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
D90- no call
|
15 Participants
|
4 Participants
|
|
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
D90- 1 call
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: 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
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
Outcome measures
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 Participants
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
|
Group Without Nurse-led Telephone Follow-up
n=7 Participants
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
|---|---|---|
|
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
|
6 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
|
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
|
6 Participants
|
Adverse Events
Group With Nurse-led Telephone Follow-up
Group Without Nurse-led Telephone Follow-up
Total
Serious adverse events
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 participants at risk
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
|
Group Without Nurse-led Telephone Follow-up
n=7 participants at risk
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
Total
n=28 participants at risk
Total of reporting groups
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Investigations
Transaminases increased
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Renal and urinary disorders
Renal failure
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
Other adverse events
| Measure |
Group With Nurse-led Telephone Follow-up
n=21 participants at risk
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
|
Group Without Nurse-led Telephone Follow-up
n=7 participants at risk
Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
|
Total
n=28 participants at risk
Total of reporting groups
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Diarrhoea
|
81.0%
17/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
57.1%
4/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
75.0%
21/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
4/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Faces soft
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Stomatitis
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
38.1%
8/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
42.9%
3/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
39.3%
11/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.1%
8/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
42.9%
3/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
39.3%
11/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
23.8%
5/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
17.9%
5/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
General disorders
Fatigue
|
23.8%
5/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
28.6%
2/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
25.0%
7/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
General disorders
Asthenia
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
28.6%
2/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
4/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
General disorders
Mucosal inflammation
|
4.8%
1/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
General disorders
Oedema peripheral
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Paronychia
|
14.3%
3/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
4/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Alveolar osteitis
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Oral fungal infection
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
5/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
28.6%
2/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
25.0%
7/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
4/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
17.9%
5/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Eye disorders
Dry eye
|
19.0%
4/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
17.9%
5/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Investigations
Weight decreased
|
19.0%
4/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
4/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Nervous system disorders
Dysgeusia
|
9.5%
2/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
0.00%
0/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
7.1%
2/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
|
Nervous system disorders
Ageusia
|
0.00%
0/21 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
14.3%
1/7 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
3.6%
1/28 • All Adverse events occurring during the course of the study (i.e., from signing the informed consent onwards through Day 90)
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER