EVALUATION OF THE IMPACT OF A THERAPY MANAGEMENT PLATFORM ON THE MANAGEMENT OF PATIENTS SUFFERING FROM ADVANCED/METASTATIC RENAL CELL CARCINOMA AND RECEIVING FIRST LINE TREATMENT WITH SUNITINIB, VERSUS STANDARD FOLLOW-UP
Conditions: Metastatic/Advanced Renal Cell Carcinoma
Sponsor: Pfizer

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RENACALL - INTERMEDIATE CARE STUDY PROTOCOL 
Study information 
Headline 
Evaluation of the impact of a therapy 
management platform on the 
management of patients suffering from 
advanced/metastatic renal cell carcinoma 
and receiving first line treatment with 
sunitinib, versus standard follow-up 
Protocol Number 
A6181213 
Protocol version 
Protocol amendment no. 3.1 
Date of last version 
21 July 2017 
Medicinal product 
Sunitinib 
Research question and objectives 
Evaluation of the impact of a therapy 
management platform on the management of 
patients suffering from advanced/metastatic 
renal cell carcinoma (a/mRCC) and 
receiving first line treatment with sunitinib 
Authors 
Dr 
 
 
 – 
Scientific committee coordinator 
Dr 
 –  
Scientific committee 
 
Dr 
 –  
Scientific committee 
 
Prof. 
 –  
Scientific committee 
 
Dr 
 –  
  
 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

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CONTENTS 
CONTENTS ...............................................................................................................................2 
1. LIST OF ABBREVIATIONS ................................................................................................5 
2. RESPONSIBILITIES ............................................................................................................6 
3. SYNOPSIS .............................................................................................................................7 
4. AMENDMENTS AND UPDATE .......................................................................................10 
5. STUDY SCHEDULE ..........................................................................................................11 
6. RATIONALE .......................................................................................................................12 
6.1 
RATIONALE ...................................................................................................12 
6.1.1. Advanced/metastatic renal cell carcinoma .................................................12 
6.1.2. Therapeutic care ..........................................................................................12 
6.1.3. Management of AEs ...................................................................................13 
6.1.4. Justification for the RENACALL study .....................................................13 
7. AIMS OF THE STUDY ......................................................................................................14 
7.1 
Main aim: ...........................................................................................14 
7.2 
Secondary aims: .................................................................................14 
7.3 
Evaluation criteria .............................................................................14 
7.3.1. 
Main outcome measure ......................................................................14 
7.3.2 
Secondary outcome measures ............................................................15 
8. METHODS ..........................................................................................................................16 
8.1. Study design ............................................................................................................16 
8.2. Methods ...................................................................................................................16 
Population of participating physicians ...........................................................................18 
STUDY PROCEDURES .........................................................................................................20 
Study period ...................................................................................................................20 
Study set-up ....................................................................................................................20 
Enrolment of participating physicians ..................................................................20 
Study set-up for physicians ...................................................................................20 
Patient selection ..............................................................................................................21 
Logistical monitoring .....................................................................................................21 
Receipt and input of satisfaction and compliance questionnaires ..................................22 
Call management ............................................................................................................22 
End of study ...................................................................................................................22 
Roles of participants .......................................................................................................22 
8.2.1. Inclusion criteria .........................................................................................23 

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8.2.2. Non-inclusion criteria .................................................................................23 
8.3. Variables ..................................................................................................................24 
8.3.1. Table of recorded data ................................................................................24 
8.4. Data sources ............................................................................................................25 
8.4.1. Data recorded by the physician: .................................................................25 
8.4.2. Data recorded via the call centre: ...............................................................25 
8.4.3. Data recorded by the patient: ......................................................................26 
8.5. Complete population justification (physicians/patients) .........................................26 
8.6. Data management ....................................................................................................27 
8.6.1. Database construction .................................................................................27 
8.6.2. Data input ....................................................................................................27 
8.6.3. Data control ................................................................................................28 
8.6.4. Coding.........................................................................................................28 
8.6.5. Final quality control ....................................................................................28 
8.6.6. Database freeze ...........................................................................................28 
8.6.7. Data management report .............................................................................28 
8.6.8. Data transfer ................................................................................................28 
8.7. Statistical analysis ...................................................................................................28 
8.7.1. Analysis strategy .........................................................................................29 
8.7.2. Statistical methods used ..............................................................................29 
8.7.3. Analysis plan ..............................................................................................29 
8.7.4. Study report ................................................................................................29 
8.8. Quality Control ........................................................................................................30 
8.9. Study limitations .....................................................................................................30 
8.8.1 
Selection bias ...................................................................................................30 
8.8.2 
Measurement bias ............................................................................................30 
8.10. Other aspects .........................................................................................................30 
8.9.1 
CRF / e-CRF ....................................................................................................30 
8.9.2 
Data storage .....................................................................................................31 
8.9.3 
CRF circuit .......................................................................................................31 
9. PATIENT PROTECTION ...................................................................................................32 
9.1. Individual information/consent ...............................................................................32 
9.2. Patient withdrawal from the study ..........................................................................33 
9.3. Medical Association ................................................................................................33 

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9.4. Data Protection: Commission Nationale de l’Informatique et des Libertés (National Data 
Protection Commission): "CNIL" .............................................................................33 
9.5. Committee for the Protection of Persons (CPP) ......................................................34 
9.6. Good Pharmaco-epidemiology Practices ................................................................34 
9.7. Patient enrolment .....................................................................................................34 
9.8. Pharmacovigilance problems and protocol or good epidemiological practice violations 34 
10. PHARMACOVIGILANCE OBLIGATIONS ...................................................................34 
11. PROPERTY AND COMMUNICATION OF RESULTS .................................................41 
11.1. Communication and publication by Pfizer ............................................................42 
11.2. Publication by participating physicians .................................................................42 
12. SCIENTIFIC COMMITTEE .............................................................................................42 
12.1. Composition ..........................................................................................................42 
12.2. Role of the Scientific Committee ..........................................................................43 
13. REFERENCES ..................................................................................................................44 
14. ANNEXES .........................................................................................................................46 
14.1. Appendix 1: Patient information and consent leaflet ............................................46 
14.2. Appendix 2: Contact authorisation form for the call centre ..................................51 
14.3. Appendix 3: ECOG ...............................................................................................52 
14.4. Appendix 4: SPC ...................................................................................................53 
14.5. Appendix 5: Non-Inclusion Register .....................................................................54 
14.6. Appendix 6: Case report form ...............................................................................59 
14.7. Appendix 7: Intervention by nurse ........................................................................79 
14.8. Appendix 8: Adverse event report form ..............................................................106 
14.9. Appendix 9: "Morisky" patient self-questionnaire (Sutent® treatment compliance)
 .................................................................................................................................108 
14.10. Appendix 10: "Physician" call centre satisfaction evaluation questionnaire ....109 
14.11. Appendix 11: "Patient" call centre satisfaction evaluation questionnaire .........109 
 

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1. LIST OF ABBREVIATIONS 
List of abbreviations used in the protocol. 
 
 
Abbreviations 
 
Terms 
a/mRCC  
Advanced/metastatic renal cell carcinoma 
ANOVA 
Analysis of variance 
GPP 
Good Pharmacoepidemiology Practices 
CATI 
Computer-assisted telephone interview 
CCTIRS 
Comité Consultatif sur le Traitement de l’Information en Matière de 
Recherche dans le domaine de la Santé (Healthcare Research Data 
Processing Advisory Board) 
CNIL 
Commission Nationale de l’Informatique et des Libertés (National Data 
Protection Commission) 
CNOM 
French national medical association 
CPP 
Committee for the Protection of Persons 
CRO 
Clinical Research Organisation 
PHC 
Public Health Code 
CTCAE 
Common Terminology Criteria for Adverse Events v4.03 of June 2010 
eCRF 
electronic Case Report Form 
ECOG 
Eastern Cooperative Oncology Group 
AEs 
Adverse events 
HTN 
Hypertension 
INCA 
Institut National du Cancer (French national cancer institute) 
INFα 
Interferon alpha 
ISPE 
International Society for Pharmacoepidemiology 
ITT 
Intention To Treat 
IV 
Intravenous 
MedDRA 
Medical Dictionary for Regulatory Activities  
NCI 
National Cancer Institute 
SOP 
Standard Operating Procedure 
PV 
Pharmacovigilance  
QC 
Quality control 
SPC 
Summary of Product Characteristics 
RECIST 
Response Evaluation Criteria in Solid Tumors 
CC 
Call Centre follow-up 
SF 
Standard Follow-up 
 
 

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2. RESPONSIBILITIES 
Pfizer medical supervisor for the study: 
M. 
  
Oncology medical supervisor, 
Pfizer Innovative Health, France 
Tel: 
 
 
Medical operations supervisor 
Ms. 
 
Oncology medical operations supervisor 
Pfizer Innovative Health, France 
Tel.: 
 
 
Post-MA 
: 
Ms. 
 
Post-MA 
 
Pfizer Innovative Health, France 
Tel.: 
 
  
Post-MA 
 
Ms. 
 
Post-MA 
 
Pfizer Innovative Health, France 
Tel.: 
 
 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

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3. SYNOPSIS 
Rationale 
Targeted treatment therapy requires close patient monitoring to ensure that the drug is correctly used and, 
more specifically, to prevent and manage any adverse events. Better adverse event management helps 
optimise treatment duration and clinical benefit. Most targeted therapies are taken orally and adverse 
events frequently occur at home. Regular contact via a therapy management platform could not only 
reduce the proportion of patients presenting with grade 3, 4 adverse events, but could also reduce the 
number of unscheduled hospitalisations and consultations associated with poor tolerance. 
No other studies evaluating the impact of therapy management platform follow-up versus standard follow-
up on the management of patients suffering from metastatic/advanced renal cell carcinoma and treated 
with targeted oral therapy have yet been published. The improvement of the management of patients 
treated by targeted oral therapy is one of the priorities of the cancer 2 plan, drawn up by INCa 
(http://www.plan-cancer.gouv.fr/). 
The RENACALL study aims to evaluate a real-life mode of patient management that differs from 
conventional management, with no additional intervention required by the physician. 
All patients benefit from standard follow-up plus follow-up by a therapy management platform. Platform 
follow-up shall consist in regular phone calls to accompany patients in their real life home management of 
adverse events and their treatment with sunitinib (prevention, advice and guidance of patients towards 
options). 
o Objectives 
Main objective: 
- 
Evaluation of the impact of a therapy management platform on the management of patients suffering 
from advanced/metastatic renal cell carcinoma (a/mRCC) and receiving first line treatment with 
sunitinib Main outcome measure: Proportion of patients presenting with at least one grade 3 or 4 AE 
(whether related to sunitinib or not). 
Secondary aims: 
- 
To describe and estimate the proportion of patients presenting with dose reductions interruptions or 
termination of treatment (Sutent®),  
- 
To estimate the number of unscheduled medical procedures, whether related to Sutent® or not 
(number of unscheduled consultations and hospitalisations),  
- 
To evaluate treatment compliance (Morisky scale [1, 2]), 
- 
To estimate the objective response rate (ORR) according to RECIST V1.1 criteria, 
- 
To evaluate patient and physician satisfaction concerning the call centre 
- 
To describe the sequence of phone calls in terms of the number of successful calls, of actions 
undertaken by the call centre and/or by the physician 
 
 
 
 
Methods 

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Physician population 
The study shall be proposed to a list of 10 to 20 identified centres in Metropolitan France. 
 
Patient population 
 
 
An enrolment of 100 patients is expected for this study, i.e. approximately 10 patients enrolled per 
centre. These patients must meet the following inclusion and non-inclusion criteria. 
- 
Inclusion criteria 
- Man or woman aged 18 or over; 
- Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC 
recommendations; 
- Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects 
due to radiotherapy or surgical procedure prior to initiation of sunitinib; 
- Patient who can be monitored for 6 months. 
- Female patient of child-bearing age using a form of contraception during treatment with Sunitinib 
and for at least 28 days after termination of treatment with Sunitinib; 
- Patient having signed his/her consent form; 
- Patient affiliated with a social security scheme. 
 
- 
Non-inclusion criteria 
- Patient participating in a clinical trial during sunitinib treatment; 
- Patient managed by a home hospitalisation service during sunitinib treatment; 
- Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, 
or from any other significant treatment support and likely to impact adverse event management. 
- Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation; 
- Patient refusing the use of his/her personal data. 
- Patient with an ECOG performance status upon inclusion > 2; 
- Patient presenting with a serum creatinine level >1.5 times the upper limit of the normal level; 
- Patient presenting with a bilirubin level > 2 mg/dl, aspartate transaminase (ASAT) or alanine 
transaminase (ALAT) >2.5 times the upper limit of the normal value, or >5 times the upper limit of the 
normal value in the presence of liver metastases upon initiation of sunitinib treatment; 
- Patients who are staff members of a centre involved in the study, or close to one of the staff 
members of a centre directly involved in conducting the study, or patients employed by Pfizer and 
involved in conducting the study 
 
 
 
 
General organisation 
Prospective and multi-centre intermediate care study, conducted in metropolitan France on adult patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first-line sunitinib treatment.  

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Patient therapeutic management must not be modified during the study and must conform to the SPC 
recommendations. The patients will receive additional follow-up by the call centre. This follow-up 
consists in making regular phone calls (14 during the first 4 cycles) to support the patients in the 
management of their sunitinib treatment. 
The RENACALL study aims to evaluate a different mode of patient management from that performed 
during routine follow-up.  
 
Patient management varies widely according to the physician and his/her patients' needs. To avoid 
interfering in follow-up practices, each physician shall follow up their own patients according to their 
usual practices. 
 
Statistical methodology 
 
Complete population justification (physicians/patients) 
The estimated number of patients (n) is determined by the precision (i) required when estimating the 
proportion (p) of patients presenting with at least one grade 3 or 4 AE. A 95% confidence interval is 
associated with the estimation of this proportion.  
100 patients will need to be included to estimate a percentage with a 95% confidence interval whose 
amplitude, calculated by the asymptotic method, does not exclude ±9.8%. 
 

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4. AMENDMENTS AND UPDATE 
  
Amendment number 
Date 
Administrative 
or substantial 
amendment 
Modified 
protocol section  
Amendment summary 
Rationale 
 
Amendment no. 1 
04/12/2014 
Substantial 
amendment 
Patient 
information 
note and CRF 
changed the patient 
information note (deleted 
all Anglicisms) and CRF 
Requested by the CPP and 
CNIL 
Amendment no. 2 
16/11/2015 
Substantial 
amendment 
Inclusion 
criterion and 
CRF 
Added a non-inclusion 
criterion and changed the 
CRF 
Request by the Scientific 
Committee coordinator to 
add a non-inclusion 
criterion 
Changed the medical 
supervisor and updated the 
CRF following the tests 
performed 
Amendment no. 3 
18/11/2016 
Substantial 
amendment 
Rationale, 
objectives, 
Patient 
information 
note 
Deleted randomisation 
by scientific committee 
request 
The study scientific 
committee wished to find a 
solution for boosting 
inclusions and physician 
interest in the project by 
allowing them to offer 
therapy management 
platform-based follow-up 
to all their patients. Thus, it 
will be possible to compare 
the cohort formed by the 
RENACALL study to an 
historical cohort. 
Amendement no 3.1 
21/07/2017 
Non-
substantial 
amendment 
Timeline and 
safety update 
Inclusion patient period 
extension. 
Safety process update 
Following approval drom 
regulatory authorities, it 
was decided to extend the 
inclusion period until 
december 31th 2017 
Following the answers 
from our safety service, it 
xas decided to keep the 
initial safety paragraf in the 
protocol. 

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5. STUDY SCHEDULE 
 
Task 
Scheduled date 
Protocol submission to the Bordeaux CPP 
July 2014 
Protocol submission to the CCTIRS 
July 2014 
Protocol submission to the French national medical association (CNOM) 
August 2014 
Protocol submission to CNIL 
August 2014 
Enrolment of participating physicians 
October 2014 
Data collection start date 
March 2016 
End of data collection 
November 2018 
Freeze database and initial analysis 
Janvier 2019 
Final Report 
Mars 2019 
 

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6. RATIONALE 
RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of a 
therapy management platform on the management of patients suffering from advanced/metastatic renal 
cell carcinoma and receiving first line treatment with Sutent®. 
100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall 
benefit both from conventional follow-up and from additional therapy management platform-based 
follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life 
home management of their treatment with sunitinib (prevention, advice and guidance of patients towards 
options). 
 
The study's main outcome measure is the proportion of patients presenting with at least one grade 3 or 4 
AE (whether related to sunitinib or not). 
6.1 RATIONALE 
6.1.1. Advanced/metastatic renal cell carcinoma 
In France, the incidence of renal cell carcinoma is estimated at 8,300 new cases per year since 2000 and 
represents 2 to 3% of adult cancer cases (7th most frequent cancer in men and 9th most frequent in women 
in France) [3-5]. It is responsible for 3,600 deaths per year. In the United States, there are a little more 
than 38,000 new cases of renal cell carcinoma each year, corresponding to 5% of all cancers  [6]. The sex-
ratio is of two men for one woman, with a median age at diagnosis of 70 years. 
Renal cell carcinoma is the third urological cancer in terms of frequency, though it remains the first in 
terms of specific mortality, with a 40% death rate [6]. Between 10 and 40% of patients diagnosed with 
renal cell carcinoma display a metastatic form from the outset [6, 7]. Moreover, 10 to 30% of RCCs will 
become metastatic, with a mean time to detection of metastases of 36 months [6-10].  
6.1.2. Therapeutic care  
Before the introduction of targeted therapies, the median survival time for patients suffering from 
metastatic renal cell carcinoma was of ten months [11]. The development of targeted therapies, acting both 
on the mechanisms of angiogenesis and of cell proliferation, has revolutionised the management of renal 
cell carcinoma [12, 13]. These treatments have led to a progression-free survival with a median value 
estimated at 11 months and an overall survival of 30 months [14-16]. 
Sunitinib is a tyrosine kinase inhibitor indicated for the treatment of advanced and/or metastatic renal cell 
carcinoma. It is currently considered as reference first-line treatment [17]. The pivotal sunitinib vs. INF 
alpha trial demonstrated a significant improvement in progression-free survival of 11 months under 
sunitinib versus 5 months under INFα [18]. By virtue of their mechanisms of action, targeted therapies are 
accompanied by adverse events of variable severity. For sunitinib, it has been shown that certain adverse 
events are predictive of the patient's response to the treatment [19-22]. Common toxicities have been 
described for all anti-angiogenic drugs (asthenia, HTN, cardiac toxicity) [23]. In the pivotal sunitinib trial 
[18], 84% of patients treated with sunitinib presented with at least one grade 3 or 4 adverse event 
(according to CTCAE version 4.03 of June 2010), whether associated with sunitinib or not. 
Cardiovascular, dermatological, haematological, gastrointestinal and metabolic disorders require special 

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surveillance. In the Santorin study (French study of the real-life use of anti-angiogenic drugs) [16], 58% of 
patients treated with sunitinib presented with at least one grade 3 or 4 adverse event (according to CTCAE 
version 4.03 of June 2010), whether associated with sunitinib or not. In the EAP "Expanded Access 
Program" trial  [24], 58.8% of patients treated with sunitinib presented with at least one grade 3 or 4 
adverse event (according to CTCAE version 4.03 of June 2010), whether associated with sunitinib or not. 
The main grade 3 events were hypertension (12.6%), hand and foot syndrome (12.3%), fatigue/asthenia 
(11.9%), neutropenia (10.6%) and anaemia (9.3%). 
One adverse event led to hospitalisation in 35% of patients. The main grade 3 events that led to 
hospitalisation were anaemia (22 patients, 7.3%), deterioration of general condition (10 patients, 3.3%), 
hypertension (7 patients, 2.3%), fatigue/asthenia (6 patients 2.0%) and a cardiovascular event (6 patients, 
2.0%). 65% of patients with at least one dose reduction, 61.6% of patients with at least one cycle 
postponement. 
6.1.3. Management of AEs  
Targeted treatment therapy requires close patient monitoring to ensure that the drug is correctly used 
(dosage, compliance) and, more specifically, to prevent and manage any adverse events. Better adverse 
event management helps optimise treatment duration and clinical benefit. Most targeted therapies are oral 
and adverse events frequently occur at home. Thus, for improved prevention and AE management, a link 
between medical personnel and the patient is necessary. Regular contact via a therapy management 
platform could not only reduce the proportion of patients presenting with grade 3, 4 adverse events, but 
could also reduce the number of unscheduled hospitalisations and consultations associated with poor 
tolerance. 
A study conducted at the Cochin hospital in Paris [25] demonstrated the benefits of a therapy management 
platform in the management of patients treated by standard IV chemotherapy. The purpose of this study 
was to evaluate the rate and cost of unscheduled hospitalisations induced by chemotherapy in a group of 
patients treated by chemotherapy: patients receiving standard follow-up (96 patients) and patients 
benefiting from call centre follow-up (259 patients). This study revealed a decrease in the unscheduled 
hospitalisation rate induced by chemotherapy from 4.9% to 2.4% (p<0.01) in the call centre group, relative 
to the standard follow-up group (383-day reduction in hospitalisation), along with a cost reduction of 
approximately $292.089 per year. Another study [26] evaluating the effectiveness of a programme for 
optimisation of the chemotherapy network monitoring program (PROCHE), also demonstrated a reduction 
in the incidence of side effects (in particular fatigue and pain) in the group monitored by this programme.  
6.1.4. Justification for the RENACALL study  
No other studies evaluating the impact of therapy management platform follow-up versus standard follow-
up on the management of patients suffering from metastatic/advanced renal cell carcinoma and treated 
with targeted oral therapy have yet been published. The improvement of the management of patients 
treated by targeted oral therapy is one of the priorities of the cancer 2 plan, drawn up by INCa 
(http://www.plan-cancer.gouv.fr/).  

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7. AIMS OF THE STUDY 
7.1 Main aim: 
Evaluation of the impact of a therapy management platform on the management of patients suffering from 
advanced/metastatic renal cell carcinoma (a/mRCC) and receiving first line treatment with sunitinib  
Primary assessment criterion: Proportion of patients presenting with at least one grade 3 or 4 AE (whether 
related to sunitinib or not).  
7.2 Secondary aims: 
- 
To describe and estimate the proportion of patients presenting with dose reductions interruptions or 
termination of treatment (Sutent®),  
- 
To estimate the number of unscheduled medical procedures, whether related to Sutent® or not 
(number of unscheduled consultations and hospitalisations),  
- 
To evaluate treatment compliance (Morisky scale [[1, 2]), 
- 
To estimate the objective response rate (ORR) according to RECIST V1.1 criteria, 
- 
To evaluate patient and physician satisfaction concerning the call centre  
- 
To describe the sequence of phone calls in terms of the number of successful calls, of actions 
undertaken by the call centre and/or by the physician 
 
7.3 Evaluation criteria 
7.3.1. Main outcome measure  
The main outcome measure is defined by the proportion of patients presenting with at least one grade 3 or 
4 adverse event (whether associated to Sutent® or not) during the first 4 treatment cycles (study follow-up 
period), based on the 'Common Terminology Criteria for Adverse Events' (CTCAE) version 4.03 of June 
2010. 
Adverse events shall be collected: 
- 
via the e-CRF, by the physicians, during routine follow-up consultations,  
- 
Via the CATI system, by the call centre nurses during phone calls. Declaration to the Pfizer 
Pharmacovigilance department within the statutory time limits by the CATI system at the end of each 
patient interview. AEs will also be sent to the participating physicians via the e-CRF for review and 
validation during the patient follow-up visits.  
Adverse events precisely described to the nurses by the patients, with a proposed gradation by the nurse 
where applicable, shall be definitively graded by the participating physician during the patient 
consultations at the centre, according to the CTCAE version 4.03 of June 2010, available from the study 
website. 
Pharmacovigilance files (AE report form and additional file generated from the CRF data) shall 
automatically be created from the e-CRF. One file shall be created for each AE upon completion of the 
visits made by the participating physician and after approval of all reported cases. 

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7.3.2 Secondary outcome measures 
Each of these criteria shall be evaluated based on the data collected via the e-CRF by the physicians and 
via a self-questionnaire provided to the patients. 
- 
Dose reduction, treatment interruptions and termination (sunitinib)  
Description of dose reduction 
o Proportion of patients having had at least one dose reduction relative to the initial dose 
o Reasons for dose reduction 
o Change of dose (initial dose and new dose prescribed) 
Description of treatment interruptions 
o Proportion of patients having temporarily interrupted their sunitinib treatment (including 
postponement of the start of the subsequent cycle) 
o Mean interruption duration 
o Cause for the interruptions 
Treatment termination 
o Proportion of patients having stopped taking sunitinib 
o Reasons for termination 
- 
Unforeseen medical procedures: 
o Mean number of unforeseen consultations 
o Mean number of unscheduled hospitalisations  
Unforeseen medical procedures correspond to unscheduled consultations and hospitalisations, whether 
associated with sunitinib or not.  
- 
Treatment compliance 
Treatment compliance shall be evaluated directly with the patients using the standardised questionnaire 
validated by Morisky, available in appendix 9 of the protocol.  This generic therapeutic compliance 
evaluation questionnaire comprises 4 questions scored as 0 for "YES" and 1 for "NO".  The points for 
each question are added up to obtain a score ranging from 0, if all questions are answered by "yes" 
(reflects poor compliance) and 4, if all questions are answered by "no" (reflects good compliance). 
It shall be completed, during the routine follow-up visit with the participating physician, after the sixth 
week of cycles 1, 2 and 4, via a self-questionnaire issued to the patient.  
Similarly, the questions shall be asked orally and the answers entered into the CATI system during the W4 
phone interviews of cycles 1, 2 and 4 between the platform nurse and the patient. This evaluation shall be 
used, on the one hand, to measure the compliance after the 4th week of treatment and, on the other hand, to 
estimate the match between patient declarations made during the W4 measurement and the consultation 
with the attending physician. The match measurement shall be used for information purposes only, insofar 
as the questionnaire is validated for self-completion by the patient himself/herself, not for submission of 
the questions by a third party (potential declaration bias concerning compliance). 
 
- 
Response to treatment 
Evaluation of the objective response rate (ORR) according to RECIST V1.1 criteria,  

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- 
Patient and physician satisfaction concerning the call centre  
The evaluation of patient satisfaction concerning the call centre shall be evaluated by a self-questionnaire 
issued to the patients during the final visit (appendix 11), used to determine the various dimensions of 
their satisfaction (overall satisfaction, satisfaction concerning advice, service and management).  
This questionnaire, drawn up in the context of the study, shall consist of 8 questions, with answers in the 
form of a semantic measurement scale with an odd number of categories (5) and with a level of control 
preventing any opinion from being expressed. Each answer is assigned a positive or negative score, thus 
enabling the data to be processed, along with mean and standard deviation.  
Similarly, physicians' satisfaction shall be collected at the end of the study via a dedicated e-CRF module 
(appendix 10). For the physicians, only three satisfaction dimensions will be evaluated via 5 questions 
(overall satisfaction, satisfaction concerning advice and management), satisfaction concerning the service 
does not apply to them. 
- 
Description of phone calls  
o Number of successful calls,  
o Action undertaken by the patient, 
o Action undertaken by the call centre, 
o And/or action undertaken by the physician, 
o Adverse event declaration. 
Each call shall give rise to an automatic call report, available to the physician on the e-CRF (action 
undertaken by the patient, adverse event declaration). 
 
8. METHODS 
8.1. Study design 
The RENACALL study is a prospective and multi-centre intermediate care study conducted in 
metropolitan France on adult patients suffering from advanced/metastatic renal cell carcinoma and 
receiving first-line sunitinib treatment. The study shall be conducted in 10 to 20 centres in charge of renal 
cell carcinoma. 
8.2. Methods 
Patients meeting the inclusion and non-inclusion criteria shall be offered to take part in the RENACALL 
study. 
Patient therapeutic management within the establishment must not be modified during the study and must 
conform to the SPC recommendations. Additionally, patients will receive supplementary follow-up by the 
call centre. 
The RENACALL study aims to evaluate real life patient management. 
 
 
 
 
 

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Figure 1. General study organisation 
 
The patients included in the study will benefit from standard follow-up plus follow-up by a therapy 
management platform. Platform follow-up shall consist in regular phone calls (see Figure 2) to accompany 
patients in their real life home management of their treatment with sunitinib (prevention, advice and 
guidance of patients towards options). 
 
 
Figure 2. Phone call scheme  
 
The study data shall be collected via an electronic case report form: 
- 
By the physician during the inclusion and follow-up visits at the hospital,  
- 
By 
the 
therapy 
management 
platform 
nurses 
during 
the 
phone 
calls, 
They will have special user profile access to pre-fill the data collected during the phone calls. 
- 
The physicians will have access to the data and reports filled in the by the nurses during the phone 
calls. 
 
Proposal of 10 to 20 oncology centres likely to take part in the study 
Centres contacted by email with study participation proposal 
Validation of study agreements and transmission of e-CRF 
identifiers 
Patient information and signing of the patient consent form 
Completion of the contact form 
Follow-up visit at end of cycles 1, 2 and 4 
Inclusion visit 
Phone calls as per agreed scheme (figure 2) 
Email sent to all selected centres to ascertain project feasibility at each centre 

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The period for patient inclusion into the study is of 22 months. Patients shall be monitored during the first 
4 cycles of sunitinib treatment, i.e. for approximately 6 months (1 treatment cycle lasts 6 weeks). 
Follow-up visits shall be conducted for all study patients according to standard patient follow-up, i.e. 
approximately at the end of cycles 1, 2 and 4, during routine patient consultations at the centres (at 
approximately W6, W12 and W24). 
At the end of follow-up, the patients will be asked to fill in a platform satisfaction questionnaire. The 
participating physicians will be asked to fill in this satisfaction questionnaire at the end of the study. 
The therapy management platform will be managed via a call centre using a CATI (Computer-Assisted 
Telephone Interview) system. This system is used to instantly enter into the computer all the data collected 
in response to specific questionnaires submitted by the nurses during the telephone calls, in the context of 
follow-up.  
 
Patient management varies widely according to the physician and his/her patients' needs. To avoid 
interfering in follow-up practices, each physician shall follow up their own patients according to their 
usual practices. 
Population of participating physicians 
The study shall be proposed to 58 physicians at 50 oncology centres in metropolitan France caring for 
patients suffering from metastatic/advanced renal cell carcinoma. 
Each physician shall be questioned concerning the annual number of patients meeting the inclusion and 
non-inclusion criteria. It shall also be questioned concerning the systems in place in their centre. 
Thus, each centre receiving at least 10 patients per year and that does not already possess a coordinating 
nurse or platform for routine patient follow-up may be selected to take part in this project, forming the list 
of identified physicians. 
This step, conducted upstream of the study, will allow the identification of 20 to 25 physicians eligible to 
take part in the study. 
A description of the sample of centres shall be provided subsequently, based on the identification data of 
the participating physicians from each centre (age, gender, geographical situation, etc.). We shall then 
check that the sample of participating physicians is representative of oncologists in France in terms of 
centre size and type, in order to guarantee external study validity. 
The patients included in the RENACALL study will be monitored not only in the standard manner, but 
also via the therapy management platform. In the context of standard follow-up, they will be issued the 
usual logbooks for their treatment, along with any documents routinely used by the centres. 
 
Patient follow-up via a therapy management platform consists in making regular phone calls (14 during 
the first 4 cycles) to support the patients in the management of their sunitinib treatment. 
 
The calls shall be made from a centralised therapy management platform located in the Paris region, by 
nurses specifically trained for this role. If necessary, the nurses may be assisted by physicians from the 
platform.  
 

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The aim of these calls is to support the patients in the management of their treatment by listening to and 
advising them, implementing preventive measure and taking actions when deemed necessary; the purpose 
of these calls is to support patients in the management of their sunitinib treatment. 
 
Call frequency is presented in the following figure:  
 
 
Figure 3. Call frequency  
The chosen rate is of:  
- For the first two cycles, C1 and C2: 5 calls during the first 5 weeks of each cycle (no call during 
week 6 as the patients are usually seen in consultation), 
- For cycles 3 and 4: 2 calls per cycle on weeks 2 and 4. 
(decision by the CS not to make calls on weeks 1, 3 and 5). 
These calls will be made for patients treated with Sutent®; in the event of termination of treatment during 
the follow-up period, the call following termination will close the intervention. In the event of cycle start 
postponement, the first call made shall be postponed to match the expected organisation (cycles 1 and 2: 
first call during week 1 of the cycle; cycles 3 and 4: first call during week 2 of the cycle). 
Call organisation has been defined in collaboration with the concerned healthcare professionals and based 
on prior experience of therapy management in oncology. It shall be as follows:  
- build the patient's trust by covering various aspects of the disease and/or of side effects; 
- patient education to avoid serious adverse events (e.g.: dietary advice, sports exercises, etc.); 
- guidance and advice when deemed necessary; for example, this may be to:  
o advise the patient to take medicinal products prescribed upstream by his/her physician,  
o guide the patient towards his/her oncologist or general practitioner or other. 
The patients will also be able to contact the call centre nurses at any time during the study. A specific 
module will enable the nurse to record this type of "unscheduled" call.  
The platform will also play a coordination role between patients and healthcare professionals, through the 
following actions:  
- Draw up a call report on the e-CRF. This latter shall include the number of successful calls, along 
with the actions performed by the call centre for each call, such as: no special action, or self-
medication, or consultation request to one of the physicians; 
- Report adverse events identified by the platform nurses and monitor actions performed by the 
physicians following declaration of an adverse event by the call centre (symptomatic treatment, 
hospitalisation, reduction/interruption/termination of the sunitinib dose, etc.). The call centre 
nurses will declare, within the statutory time frame, to the Pfizer Pharmacovigilance department, 
any adverse events reported by the patients during a phone call.  
- Access for oncologists to a call report 

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At the end of the follow-up cycle, those patients still treated with sunitinib and wishing to continue the 
therapy management, may benefit from this service until the outcome of the disease. Any adverse events 
are thus declared in the context of spontaneous declaration.  
 
STUDY PROCEDURES 
This is an intermediate care study; the choice of patient therapeutic strategy (implementation of sunitinib 
treatment) is not guided by the study.  
Study period 
The patient inclusion period is of 22 months. Patients shall be monitored during the first 4 cycles of 
sunitinib treatment, i.e. for approximately 6 months (1 treatment cycle lasts 6 weeks). 
 
Follow-up visits shall be conducted according to standard patient follow-up, i.e. approximately at the end 
of cycles 1, 2 and 4, during routine patient consultations at the centres (at approximately W6, W12 and 
W24). 
Study set-up 
Enrolment of participating physicians  
The study shall be proposed to 58 physicians at 50 oncology centres in metropolitan France caring for 
patients suffering from metastatic/advanced renal cell carcinoma. 
Those physicians, accepting to take part in the study and with a suitable active file of patients, shall make 
up the list of eligible physicians. 
Study set-up for physicians 
The eligible physicians shall be invited to take part in the study. This participation shall be embodied 
through the signing of the financial agreement. Upon validation of this agreement, a set-up visit will be 
organised to present all documents to the participating physician and to appointed members of his/her 
staff. 
 
After this visit, the physicians will receive an email containing a link for the study website, along with 
their login ID and password.  
On this website, they will have access to all study elements, i.e.: 
o A letter from the Scientific Coordinator, 
o A synopsis and protocol, along with the various amendments 
o A physician's check-list, 
o The CPP ruling, 
o The CCTIRS ruling, 
o The CNIL authorisation, 
o The file acknowledgement of receipt by the CNOM, 
o The patient forms, 
o The case report forms. 
o A FAQ populated in real-time by the physicians' comments 
During the set-up visit, they will also be issued: 
o The patient information/consent forms, 

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o The Morisky questionnaires, 
o The "patient" platform satisfaction questionnaires,  
o The postage-paid envelopes required to return the questionnaires. 
 
Each participating physician will be assigned a unique number (0001 to 00XX).  
Before being issued to the patient, each patient questionnaire must be numbered with the patient number 
assigned during inclusion visit data input on the study website. 
Moreover, the patient will also be asked to enter his/her age and gender in order to be able to correlate the 
questionnaires if the patient's number is omitted. 
Patient selection 
The physician will ensure that his/her patient meets all selection criteria. The physician will inform the 
patient using an information form and will ask him/her whether he/she accepts that his/her personal data 
be collected in the context of the RENACALL study. The patient will be asked to sign a written consent, 
certifying that he/she accepts to take part in the study and to provide his/her phone number for therapy 
management platform calls. 
After signing the consent form, the physician will ask the patient to fill in a contact form (Appendix 2). 
This form is then sent exclusively to the therapy management platform. This form can be printed from the 
e-CRF. It shall contain the patient's identification number for the call platform. Thus, the patients will be 
assigned a research identification number, IDstudy, (in the context of the study) and a platform 
identification number IDcall (for calls), enabling the team in charge of calls to maintain the patients 
personal data in plain text.  
When the patient is included in the study, the physician must also fill in the physician inclusion 
questionnaire during the consultation. 
 
Logistical monitoring 
The participating physicians will be monitored by a team of research associates specifically trained for the 
project. This monitoring can be implemented in various manners: phone calls, email, specific post and 
newsletters. 
Emphasis shall be placed on the quality of these contacts as they shall promote the involvement and 
quality of work performed by the participating physicians. Each physician shall, insofar as possible, be 
monitored by the same research associate, from enrolment to closure of the study. 
The research associates shall follow up on incomplete or incoherent data (incoherence, lack of response 
and omission checks) and shall maintain constant contact with the participating physicians. During the 
patient selection period and depending on the number of inactive participating physicians (no patient 
selected), the research associates may be required to make follow-up calls to these latter. 
Moreover, a study-specific freephone number shall be set up for the participating physicians, in order to 
immediately answer any queries they may have throughout the duration of the study. 
In terms of traceability, all "incoming" calls via the freephone number and "outgoing" calls (selection call, 
follow-up call, etc.) will give rise to a written report (date, purpose of the call, steps to take, etc.) and will 
be entered into a log. 

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Receipt and input of satisfaction and compliance questionnaires 
The compliance and satisfaction questionnaires completed by the patients will be sent directly to Pfizer by 
means of postage-paid envelopes provided to the participating physicians.  
After acknowledging receipt, Pfizer sends them in batches to the CRO in charge of data input, where they 
are entered in duplicate into the database. 
Call management  
The nurse in charge of patient follow-up via the "therapy management platform", upon receipt of the 
contact sheet, will enter the patient's contact details into the CATI system. An call identification number 
(IDcall) will be assigned to the patient. This database will be secure and accessible via login and password 
to persons in charge of making the calls from the platform. When recording the patient's file, these data 
will be encrypted in the database. It will subsequently be impossible to access the complete IDstudy / 
IDcall / patient details chain.  
 
Calls will then be performed according to intervention procedures (Appendix 8) defined for the patients.  
End of study  
A patient leaves the study in one of the following cases: 
- 
once all 4 treatment cycles have been completed. 
- 
when the patient stops his/her treatment with sunitinib, for whatever reason. 
- 
when the patient withdraws from the study, or is removed by the participating physician.  
A follow-up visit is conducted and an end of treatment sheet is filled in at the end of the study 
The research associate will inform the physician of the end of the patient recruitment period and of the end 
of the follow-up period. He/she may be required to follow up on any missing documents required for 
remuneration, or to resolve any collected data inconsistencies identified during data management.  
 
Roles of participants 
- 
Logistics centre: Pfizer's Medical Operations Department, via its research associates, will be in charge 
of the centralised monitoring of participating physicians (use of the Pfizer non-interventional study 
management database). 
- 
Participating physicians: These latter are responsible for patient selection and questionnaire data 
collection, while conforming to the intermediate care study protocol and agreement. 
- 
Platform nurses: the nurses are in charge of calling the patients included in the study and for entering 
the corresponding data into the e-CRF. 
- 
Monitors: The monitors are in charge of setting up the study at the centres. They are also in charge of 
conducting at least one follow-up visit per year and per centre, along with the closing visit. During 
these visits, the monitors are required to ensure that the Site Master File (SMF) is properly kept, to 
check e-CRF completion and to ensure that they mad the patient's source file, along with the 
declaration of AEs to Pfizer's pharmacovigilance department in accordance with paragraph 9 of the 
protocol. 

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8.2.1. Inclusion criteria 
This study can only achieve its aims if the appropriate patients are included. The following inclusion and 
non-inclusion criteria are designed to select patients for whom the protocol is deemed appropriate by their 
physician. 
- Man or woman aged 18 or over; 
- Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC 
recommendations; 
- Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects 
due to radiotherapy or surgical procedure prior to initiation of sunitinib; 
- Patient who can be monitored for 6 months. 
- Female patient of child-bearing age using a form of contraception during treatment with Sunitinib 
and for at least 28 days after termination of treatment with Sunitinib; 
- Patient having signed his/her consent form; 
- Patient affiliated with a social security scheme. 
8.2.2. Non-inclusion criteria 
- Patient participating in a clinical trial during sunitinib treatment; 
- Patient managed by a home hospitalisation service during sunitinib treatment; 
- Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, 
or from any other significant treatment support and likely to impact adverse event management. 
- Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation; 
- Patient refusing the use of his/her personal data. 
- Patient with an ECOG performance status upon inclusion > 2; 
- Patient presenting with a serum creatinine level >1.5 times the upper limit of the normal level; 
- Patient presenting with a bilirubin level > 2 mg/dl, aspartate transaminase (ASAT) or alanine 
transaminase (ALAT) >2.5 times the upper limit of the normal value, or >5 times the upper limit of the 
normal value in the presence of liver metastases upon initiation of sunitinib treatment. 
- Patients who are staff members of a centre involved in the study, or close to one of the staff 
members of a centre directly involved in conducting the study, or patients employed by Pfizer and 
involved in conducting the study 
 
 
 
 
 
 
 
 
 
 
 
 

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8.3. Variables 
8.3.1. Table of recorded data 
During the routine patient consultations at the centres: 
 
 
V1: 
Inclusion 
T0 
V2: end of 
cycle 1 
W6 
V3: end of 
cycle 2 
W12 
V4: end of 
cycle 4 
W24 
Data filled in by the physician via the e-CRF 
Compliance with eligibility criteria 
x 
 
 
 
ECOG performance status 
x 
x 
x 
x 
Sociodemographic characteristics 
x 
 
 
 
History of the disease 
x 
 
 
 
Disease progression 
 
x 
x 
x 
Biological, histological and metastatic examination data 
x 
x 
x 
x 
Conditions of sunitinib use 
x 
 
 
 
Modification of conditions of sunitinib use 
 
x 
x 
x 
Concomitant treatments 
x 
x 
x 
x 
Pharmacovigilance data 
 
x 
x 
x 
Medical procedures (calls, consultations, hospitalisations), planned or 
unforeseen 
 
x 
x 
x 
Issuing of Sunitinib treatment support equipment 
x 
x 
x 
x 
Data filled in by the patient (self-questionnaire) 
Compliance (Morisky) 
 
x 
x 
x 
Data filled in by the physician and the patient 
Satisfaction concerning the call centre filled in by the physician and the 
patient 
 
 
 
x 

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8.4. Data sources 
8.4.1. Data recorded by the physician: 
Upon inclusion 
The inclusion visit enables the physicians to document the following parameters: 
o Compliance with inclusion criteria; 
o ECOG performance status; 
o Patient's sociodemographic characteristics; 
o History of the disease; 
o Biological, histological and metastatic examination data; 
o Conditions of sunitinib use; 
o Concomitant treatments; 
o Issuing of treatment support equipment and planned support. 
During the end-of-cycle 1, 2 and 4 visits  
During the follow-up visits, the following parameters are recorded by the physicians, via the e-CRF: 
o Disease progression; 
o Biological, histological and metastatic examination data; 
o Possible modifications to the conditions of sunitinib use (change of dose, treatment plan, 
temporary interruption or termination); 
o Concomitant treatments; 
o Pharmacovigilance data (recording of adverse events, degree of severity and description of 
the AE: intensity, symptoms, impact on patient follow-up, examinations performed, actions 
implemented); 
o History of calls and consultations with a healthcare professional during the cycle 
(scheduled and unscheduled). 
o Hospitalisation during the cycle (scheduled and unscheduled). 
o Issuing of treatment support equipment and planned support. 
 
The end of cycle 4 visit will represent the final visit. 
At the end of the study  
The participating physicians will fill in on the e-CRF a questionnaire on their level of satisfaction 
concerning the call platform. 
8.4.2. Data recorded via the call centre: 
The patients will have received phone calls on W1, W2, W3, W4 and W5 of the first two cycles, then 
every two weeks, W2 and W4 for cycles 3 and 4. 
During the calls made by the nurses, all of the data of the specific call questionnaires (Appendix 6: Nurse 
intervention script) shall be recorded via a CATI system used to instantaneously enter the data collected 
into a software application. 
 

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The following data will be collected: 
o Number of call attempts 
o Patient's general condition; 
o Treatment taking: 
o Tolerance and occurrence of adverse events (description of the AE: intensity, symptoms, 
impact on the patient, examinations performed, actions implemented; 
o Proposed action 
 
A summary of calls shall be issued to the participating physicians. The adverse events collected during the 
calls shall be recorded in the participating physicians' CRF with a view to validating them during the 
follow-up visits performed by the participating physician.  
8.4.3. Data recorded by the patient: 
The patients shall be asked to fill in 2 self-questionnaires: 
- 
The Morisky questionnaire (Appendix 10): 4 items used to evaluate treatment compliance with one 
additional item concerning the occurrence of adverse events. This questionnaire shall be filled in at the 
end of the 6th week of cycles 1, 2 and 4; 
- 
A satisfaction questionnaire (Appendix 11) concerning the call platform (drawn up in the context of 
this study) filled in during the end-of-study visit (6th week of cycle 4), or upon treatment termination. 
8.5. Complete population justification (physicians/patients) 
The patients included in this study will receive support from a therapy management platform in addition to 
usual follow-up by their oncologist. 
 
The estimated number of patients (n) is determined by the precision (i) required when estimating the 
proportion (p) of patients presenting with at least one grade 3 or 4 AE. A 95% confidence interval is 
associated with the estimation of this proportion. The smaller the amplitude of this confidence interval, the 
greater the precision. Precision is given by the following formula: 
 
 
 
Depending on the observed proportion and on the size of the studied population, the following precision 
levels may be achieved: 
 
Observed 
proportion 
Resulting precision 
n=75 
n=100 
n=125 
10 – 90 
6.8 
5.9 
5.3 
20 – 80 
9.1 
7.8 
7.0 
30 – 70 
10.4 
9.0 
8.0 
40 – 60 
11.1 
9.6 
8.6 
50 
11.3 
9.8 
8.8 
n
p
p
i
)
(
.


1
96
1

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Precision is minimum where the amplitude of the maximum confidence interval for a given proportion is 
equal to 50%. Failing any hypothesis concerning the value of the expected proportion, the hypothesis of a 
50% proportion will be used. Thus, we can shown that 100 patients will need to be included to estimate a 
percentage with a 95% confidence interval whose amplitude does not exclude ±9.8%. 
 
Between 10 and 20 centres are expected to participate in France, that shall each include 10 patients on 
average. 
 
8.6. Data management  
The CRO in charge of data management will process the RENACALL study data for all patients. These 
data will be in electronic form for data collected from the physician during the visits, along with data 
entered into the CATI system during calls, and in hard copy form for data collected from the patients. 
All data management operations will be performed in accordance with Pfizer requirements and with CRO 
Standard Operating Procedures.  
A data management plan, used to define and describe all biometrics activities, shall be developed by the 
CRO and submitted to Pfizer for validation. 
8.6.1. Database construction 
An annotated questionnaire shall be prepared by the CRO in charge of data management. This document 
will list the names of the tables and variables. For each variable, the document will give its type, length 
and format if applicable. The annotated questionnaire will be submitted to Pfizer for validation. 
The CRO will then create a database using its own software. The structure of the database will 
documented and checked on printouts, comparing the attributes of the database variables to the 
specifications listed on the annotated questionnaire. 
Before actual data entry, the database structure and input screens will be tested and validated in 
accordance with the CRO and Pfizer Standard Operating Procedures. For this purpose, a number of 
fictitious questionnaires, generally between 3 and 5, will be filled in and entered. Validation will be 
performed by printing out the data and comparing them to the data on the questionnaires. A validation 
report shall be drafted and submitted to Pfizer. The final database structure shall be submitted to Pfizer for 
validation before any actual data can be entered. 
An audit file shall be created to save any changes made to the database. The original datum, the modified 
datum, the modification date and time, along with the person who made the change and the reason for the 
change shall be recorded in the audit file. Audit file function will be tested by altering fictitious data. A 
report shall be drafted and submitted to Pfizer. 
8.6.2. Data input 
Once the database has been validated by Pfizer, the hard copy questionnaires will be entered in duplicate 
using the CRO's software. Periodic input progress reports will be printed by the CRO and sent to Pfizer. 

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8.6.3. Data control 
A list of consistency checks used to detect any inconsistencies or aberrant answers in the questionnaires 
shall be printed by the CRO and validated by Pfizer. These checks will be programmed using the CRO's 
software, then tested on fictitious data. These fictitious data, along with test-related documents, shall be 
kept in the study binder by the CRO and made available for review by Pfizer. 
After input, the checks shall be performed continuously: a query specific to each inconsistency shall be 
generated electronically by the data control system. In order to limit the number of queries submitted to 
the participating physicians, a guide to obvious corrections can be prepared by the CRO and validated by 
Pfizer. 
 
The CRO shall provide the data control documents on simple request by Pfizer. Periodic control progress 
reports will be printed by the CRO and sent to Pfizer. 
8.6.4. Coding 
All reported adverse events shall be entered using the MedDRA coding dictionary.  
For other codings, a computer program shall be used to assign a code and preferred term to the verbatim 
text. The dictionary used shall be defined in collaboration with Pfizer. 
8.6.5. Final quality control 
A final quality control shall be performed on a sample of √n + 1 randomly drawn patients. This quality 
control shall be conducted in accordance with Pfizer's "CRF to database - QC guideline". The accepted 
error rate is of 0.5%. A new sample will be collected if the calculated rate exceeds this threshold value. 
The CRO will draft an overview of this quality control and submit it to Pfizer for review. 
8.6.6. Database freeze 
The database will only be frozen once the CRO has finished input, data control and possible coding. The 
database will be frozen in accordance with Pfizer's CT24 procedure. After validation by Pfizer, the 
database will be frozen by the CRO and made ready for statistical analysis. 
8.6.7. Data management report 
A data management report will be produced by the CRO and transmitted to Pfizer after freezing the 
database. 
8.6.8. Data transfer 
There will be no intermediate partial database transfer. At the end of the project, all paper and electronic 
documentation (database, programs and documents) will be transferred to Pfizer on CD-ROM. 
 
8.7. Statistical analysis  
A detailed statistical analysis plan will be drafted and submitted to the Scientific Committee members for 
validation before any analyses are performed. 
 

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Data for patients included in the standard follow-up group preceding amendment no. 3 will be subject to 
descriptive statistical analysis with respect to demographic, treatment plan and observed adverse event 
data. 
 
 
8.7.1. Analysis strategy 
The main analysis will be performed on the population of patients treated with sunitinib, taking into 
account all grade 3 or 4 AEs observed. Sensitivity analyses will be conducted: 
o using the "missing=failure" strategy 
Any missing values will be replaced by the value corresponding to failure, i.e. grade 3 or 4 AE. For the 
main outcome measure analysis, this implies that the patient shall be considered as being in a situation of 
failure.  
o on a population of treated patients compliant with the procedure 
The choice of a compliance threshold upon intervention must be defined in the detailed statistical analysis 
plan and before the final analysis is performed. This threshold shall consist in a minimum number of 
successful calls out of the theoretical total number of 14 calls over the entire follow-up period. 
 
8.7.2. Statistical methods used 
The descriptive analysis of qualitative and ordinal variables shall include the size and frequency of each 
modality, with its 95% confidence interval, along with the number of missing data.  
Quantitative variables will be described in table form, displaying population size, mean and median, 
standard deviation, confidence interval, along with the number of missing data. 
The profile of drop-out patients shall be compared to that of non-drop-out patients based on the available 
sociodemographic and clinical variables. 
Wherever possible, the analyses will be combined with a graphical representation. 
8.7.3. Analysis plan 
Main outcome measure analysis 
The proportion of patients presenting with at least one grade 3 or 4 AE (whether associated with sunitinib 
or not) shall be estimated in the overall population of patients treated with sunitinib. A 95% confidence 
interval will be associated with the observed proportion, using the asymptotic method, or the Clopper-
Pearson exact method.  
Analysis of secondary outcome measures  
The analysis of secondary objectives shall be detailed in the statistical analysis plan. 
8.7.4.  Study report 
The results will be presented in a study report. This study report will accurately and exhaustively 
summarise the study objectives, methods, results and their interpretation. It shall be reviewed and 
validated by the scientific committee. Any changes made to the statistical methods must be reported and 
documented in the clinical/statistical report. 

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A summary version of the final report will be sent to each participating physician after validation of 
results by the Scientific Committee. 
8.8. Quality Control 
During the study, Pfizer, via its CRAs, may conduct periodic monitoring visits to ensure that compliance 
with the protocol and with good epidemiological practice (GEP). The CRAs may examine the source 
documents to confirm that the data recorded on the e-CRF are accurate.  
Pfizer may at any time conduct quality assurance audits on the participating physician's premises, or audits 
at the request of the regulatory authorities.  
For the purposes of this inspection, the participating physician will provide direct source document access 
to the CRAs, auditors, or representatives of the competent regulatory authorities.  
It is important that the participating physician and concerned staff be available during these visits and 
during any audits or inspections, and that a sufficient amount of time be dedicated to the process. 
8.9. Study limitations 
8.8.1 Selection bias 
All eligible patients will be invited to take part in the study until the inclusion number is reached, in order 
to limit the selection of a patient profile for participation in the study. 
8.8.2 Measurement bias  
Upon set-up, the participating physicians will be asked not to change their patient management practices 
in any way during the consultations, to avoid creating a "study effect" frequently observed in studies 
measuring the impact of a procedure. The risk could be of more supportive management (in terms of 
patient follow-up) of patients, in order to provide them with the information that they would otherwise not 
receive in the context of the study. This effect, even though it may exist, is considered to be negligible. 
The study's main outcome measure concerns grade 3 and 4 adverse events (very severe) that have the 
greatest impact on patients. While it is expected that patient management via the therapy management 
platform will globally increase the volume of events reported (more frequent contact with the patient), the 
hypothesis put forward is that the most severe events will be reduced by early intervention. It is therefore 
not expected that the double reporting of events by the physicians and nurses will have an effect on the 
occurrence and reporting of grade 3 and 4 adverse events in the intervention group.  
8.10. Other aspects 
8.9.1 
CRF / e-CRF 
The term CRF and/or e-CRF, as used in this protocol, refers to a hard copy questionnaire and/or to and 
electronic record of data, depending on the data collection method used (hard copy for the patient, 
electronic for the physician). 
The CRF must be filled in for each patient included in the study. The original e-CRFs are the sole property 
of Pfizer and must not be provided to a third party in any form, with the exception of authorized Pfizer 
representatives, or the appropriate regulatory authorities, without Pfizer's written consent. 
The participating physician is responsible for recording and reporting all collected data (clinical, 
pharmacovigilance, laboratory). He/she ensures that they are legible, accurate and complete. He/she must 
make the source data available as and when required. 

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The CRF must be signed by the participating physician, or by a duly authorised member of his/her staff. 
This signature certifies the authenticity of the data collected. Any corrections made to the e-CRF of source 
documents must be dated, signed and justified and must not overwrite the initially entered data. 
In most cases, the source documents are the individual's file kept at the hospital or at the physician's 
practice. In these cases, the data recorded in the e-CRF must match those listed in these files. 
In some cases, the CRF or part thereof may also serve as a source document. 
8.9.2 Data storage 
In order to enable inspections and/or audits by the regulatory authorities or Pfizer, the participating 
physician accepts to keep registers, including the identity of all participating patients (sufficient details to 
link for example the ERC files and those of the hospital), to inform all patients via the information/consent 
letter and to keep an initialled and signed copy of the consent form in the source file. 
The participating physician must also keep all documents provided, along with all relevant 
correspondence (e.g.: letters, progress reports, meeting minutes, phone call reports). The files must be kept 
by the participating physician, in accordance with applicable regulations.  
Should the participating physician be unable, for whatever reason, to continue keeping the study files for 
the required period (e.g.: retirement, change of address): The participating physician must notify this 
situation to Pfizer. The study files must be transferred to an appointed individual upon acceptance by 
Pfizer, such as another physician, another institution, or an independent third party appointed by Pfizer. 
The participating physician's files must be kept for a period of at least 15 years after study termination or 
interruption, or for longer if required by local regulations. 
 
The participating physician must obtain Pfizer's written consent before destroying the files, even if the 
storage requirements have been met. 
8.9.3 CRF circuit  
The data collected from the participating physicians upon inclusion and during the patient follow-up visits 
at the end of cycles 1, 2 and 4, shall be directly entered into the study e-CRF by the physician.  
 
The data collected by the platform during the phone calls shall also be directly entered into the database 
via the CATI system. An aggregated call summary shall be made available to the participating physician 
on the study website (e-CRF).  
via the e-CRF, by the physicians, during routine follow-up consultations, 
Adverse events identified by the nurses during the phone calls shall be declared, after the calls, to the 
Pfizer pharmacovigilance department and shall be saved to the physician's e-CRF via the CATI system. 
Using the e-CRF, the participating physician review any adverse events declared by the nurses during the 
patient follow-up visits.  
Where applicable, requests for additional information by the Pfizer pharmacovigilance department shall be 
sent to the person who declared the event (participating physician / nurse).  
Follow-ups shall be filled in either by the nurses, or by the participating physicians, depending on the date 
on which the adverse event occurred.  
The declarations and their follow-ups will be compiled by centre number and patient number.  
The severity score (grade) estimated by the participating physician shall be entered into the e-CRF. 

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If the patient fills in a logbook (book issued according to usual patient practice), the patient logbook data 
will serve as the basis for the patient interviews during calls and visits. The logbook will not be 
transmitted to the logistics centre. 
The patient compliance questionnaires (end-of-cycle 1, 2 and 4 visits) and patient satisfaction 
questionnaires concerning the call centre (end-of-study visit) shall be sent to the logistics centre. After 
acknowledging their receipt, they are sent to the CRO in batches for input. 
The therapy management platform satisfaction questionnaire shall be filled in by the physician via the 
study website, using a specific e-CRF module accessible to the physician at the end of the study. 
 
9. PATIENT PROTECTION 
9.1. Individual information/consent 
All parties are responsible for protecting the personal details of the included patients and must disclose 
neither the patients' names, nor any other data allowing their identification in the reports, publications and 
other documents. 
A numerical code is assigned to the patient upon his/her inclusion in the study. This number, issued by 
Pfizer, shall consist of a centre number (assigned by Pfizer) and a patient number (assigned by the e-CRF). 
In this manner, no details are provided to Pfizer, thus guaranteeing patient anonymity. 
The participating physician shall keep a confidential list of patients having taken part in the study, linking 
the numerical code to the patient's actual identity. 
The persons participating in the study must be informed of the study's objective, its duration, the number 
of participants, the mode of adverse event declaration, along with their right to withdraw from the study. 
They must also be informed of the nature of data transmitted, of the intended use and recipients of these 
data, their right of access and correction, along with their right of opposition, in accordance with act 78-17 
of 06 January 1978 on data protection, amended by act 2004-801 of 06 August 2004 on the protection of 
individuals with regard to the processing of personal data. These details are given to the patients in writing 
via the "Patient information leaflet" document appended to the study protocol. 
The participating physician must ensure that each patient this latter's legal representative is fully informed 
of the nature and aims of the study, along with any possible risks associated with the patient's 
participation.  
Each time consent is obtained from the patient's legal representative, the patient's consent must then be 
obtained when this latter is in a condition to do so. 
Should a physician determine that his/her patients decision-making ability is so impaired that he/she 
cannot reasonably be consulted, then this patient cannot be included. The reasons for which the patient is 
unable to give his/her consent, however, must be stated in the non-inclusion register (patient refusal, 
impaired decision-making ability, refusal to sign the document, etc.). 
The participating physician, or the person appointed by the participating physician, obtains each patient's 
informed consent prior to any study-specific activity. The participating physician keeps an initialled and 
signed original copy of the patient's consent and gives a second copy to his/her patient. 
The patients will be asked to provide their phone details. These elements will be clearly explained in the 
information leaflet issued to the patient. The details of data storage will also be explained. The patient will 

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sign a consent form certifying that he/she accepts the telephone exchanges with the platform, along with 
the communication of his/her phone details, provided on this document. 
In the case of the study, the persons in charge of the audit will have direct access to the patients' original 
medical data to check the study procedures and/or data. This access will be clearly stipulated in 
information provided to the patients who must, in this case, have signed an informed consent form. 
9.2. Patient withdrawal from the study 
A patient can withdraw from the study at any time, or be removed at any time by decision of the 
participating physician. 
If a patient fails to attend a scheduled visit, all efforts must be made to contact this patient. In all cases, 
withdrawal from the study must be documented. The participating physician must specify the reasons for 
withdrawal from the study, he/she must attempt to make a further appointment for a visit and, if necessary, 
to monitor any unresolved adverse event. 
If the patient withdraws from the study, also withdrawing his/her consent to the disclosure of future 
information, no other evaluations should be conducted and no additional data should be collected. 
The sponsor may keep the data collected prior to withdrawal of consent. 
9.3. Medical Association 
Pursuant to article L.4113-6 (former L.365-1) of the Public Health Code, the following documents must 
be sent by the study sponsor to the CNO: 
 Final protocol and amendments 
 Data collection questionnaires 
 List of physicians identified for participation in the study and members of the scientific committee (if 
available, else sent subsequently, this fact should be specified in the accompanying letter) 
 Financial agreement proposed to the participating physicians and scientific committee members. 
 Patient information/consent form 
The study sponsor must inform the CNO in writing of all financial arrangements between the sponsor, 
scientific committee members and participating physicians. 
A lack of response by the end of the two-month period after receipt of the dossier by the CNOM implies a 
favourable pronouncement. A copy of the acknowledgement of receipt shall be sent to each participating 
physician by the Sponsor. Each participating physician is then responsible for sending a copy of this 
acknowledgement of receipt, along with the signed financial agreement, to the French departmental 
medical association (CDO) to which he/she reports. 
9.4. Data Protection: Commission Nationale de l’Informatique et des Libertés (National Data 
Protection Commission): "CNIL"  
In accordance with act 78*17 of 06 January 1978 on data protection, amended by act 2004-801 of 06 
August 2004 on the protection of individuals with regard to the processing of personal data, this protocol 
shall, where applicable, be submitted to the Healthcare research data processing advisory board for 
approval. Upon receipt of the favourable pronouncement from this board, the computer file used for this 
study shall be submitted to the French national data protection commission (CNIL) for authorisation. The 
computer file can only be used upon receipt of authorisation from CNIL. 

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9.5. Committee for the Protection of Persons (CPP) 
The research conducted in the context of this study is characterised by the following points:  
- 
It does not pertain to the medicinal product but rather to the care strategies 
- 
It involves medical procedures performed in the usual manner 
- 
In light of current knowledge, the medical strategy cannot be considered as superior to the other 
- 
The study involves special monitoring procedures, which represent negligible risks. 
In this context, this research may be considered as aimed at evaluating intermediate care, as special 
monitoring procedures are stipulated by the protocol. The special monitoring procedures implemented 
represent only negligible risks and constraints for the patient. Patient information is a written document 
submitted to the CPP. The study does not alter the usual therapeutic management of the patients, nor does 
it compromise their mental or physical well-being. 
In the context of the public health act (LPSP act), a dossier shall be submitted as is to the study 
coordinator's CPP (article L 1121-1 2° of the Public Health Code).  
 
9.6. Good Pharmaco-epidemiology Practices 
This study is a real-life study for which the guidelines for Good Clinical Practices do not apply (30). This 
study must be conducted in accordance with the Pfizer protocol and standard operating procedures. 
The study shall conform to the Good Pharmaco-epidemiology Practices (GPP) directives issued by the 
International Society for Pharmaco-Epidemiology (ISPE) (31), to the 1964 Helsinki declaration (and its 
subsequent amendments and clarifications) (32) and to good pharmacovigilance practice (33).  
By signing the agreement, the physician undertakes to observe the instructions and procedures described 
in these latter and, as such, to adhere to the principles. 
9.7. Patient enrolment 
Announcements approved by the ethics committees may be used as procedures for patient enrolment into 
the study. 
If the enrolment aims are not met, actions such as extending the inclusion period may be considered. 
9.8. Pharmacovigilance problems and protocol or good epidemiological practice violations 
In the event of a ban or restriction imposed by a competent authority in any area worldwide, or if the 
participating physician is made aware of information that could influence the evaluation of the benefits or 
risks of the test product, Pfizer must be informed immediately. 
Moreover, the participating physician informs Pfizer of the urgent safety measures take to protect the 
study patients from immediate danger, along with all serious violations of this protocol, or of good 
epidemiological practice, of which the participating physician is informed. 
10. PHARMACOVIGILANCE OBLIGATIONS  
As the amendment to the protocol involves a change of pharmacovigilance procedures, the following 
paragraphs should only be taken into account once approved by the regulatory authorities.  

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All adverse events affecting patients withdrawn from the study, whatever the cause, declared upstream of 
the amendment, shall be processed according to amendment no. 2.  
Adverse events affecting patients being monitored and declared upstream shall be processed according to 
amendment no. 3. 
The table below summarises the requirements for recording adverse events on the electronic case report 
form and for declaring adverse events to via the Non-interventional study adverse event report form (NIS 
AEM Report Form) to the Pfizer pharmacovigilance department. These requirements are defined for three 
types of events: (1) serious adverse events (SAEs), (2) non-serious adverse events (AEs) (where 
applicable) and (3) situations involving exposure to a Pfizer product, including exposure during pregnancy 
or breast feeding, medication errors, overdosage, misuse, extravasation and occupational exposure. These 
events are defined in the section "Definition of an adverse event". 
 
Adverse event 
Recorded in the study 
electronic CRF  
Declared by the NISAEM 
Report Form to the Pfizer 
Pharmacovigilance 
department within 24 h of 
being made aware of the 
event 
SAE 
All  
All 
Non-serious AE 
All  
All 
 
Missing important 
information (PGR SUTENT 
V16.0) 
Use-related information:   
- 
in the paediatric 
population 
- 
in patients suffering 
from severe liver failure 
- 
in patients suffering 
from heart failure 
 
 
Situations involving exposure 
to a Pfizer medicine, 
including exposure during 
pregnancy or breast feeding, 
medication errors, overdosage, 
misuse, extravasation, lack of 
efficacy, or occupational 
exposure 
All (independently of the 
presence of an associates AE), 
except for occupational 
exposure  
All (independently of the 
presence of an associates 
AE)  
 
For each AE, the physician must identify and gather sufficient information both to determine the outcome 
of the adverse event and to ascertain whether it meets the criteria for classification as a SAE (see the 
"serious adverse events" section below). 
Adverse events must be reported to Pfizer within 24 h of the physician being made aware of them, 
whether the participating physician considers that these events are linked to a study medicine or not. 
 

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In particular, if the serious adverse event is fatal or life-threatening, Pfizer must be immediately notified, 
whatever the information available concerning the adverse event. This time frame also applies to any new 
(follow-up) information concerning previously notified adverse events. In those rare situations where the 
physician is not immediately informed of the occurrence of an adverse event, this latter must declare the 
event within 24 hours of being made aware and must specify the moment at which he/she was first made 
aware of this adverse event. 
For adverse events considered to be serious or identified in the right-hand column of the above table, that 
must be declared to Pfizer within 24 hours of being made aware, the physician must seek and provide 
Pfizer with all additional information within this 24-hour time frame. Moreover, Pfizer may ask a 
physician to urgently obtain specific additional follow-up information. This information may be more 
detailed than that entered into the study case report form. In general terms, this information shall include a 
sufficiently detailed description of the adverse event to enable a complete medical evaluation of the case, 
along with the independent determination of a possible causality. All relevant information concerning the 
event, such as concomitant treatments or diseases, must be provided. In the event of the patient's death, a 
summary of the available autopsy results must be sent as soon as possible to Pfizer, or to its accredited 
representative. 
 
Notification period 
For each patient, the adverse event notification period starts from the moment that the patient receives 
his/her first dose of study medicine, or from the date at which the patient provides his/her informed 
consent, if he/she has already been exposed to the test drug, and ends at the end of the study observation 
period, i.e. at least at the end of a period of 28 calendar days after the last administration of the test drug; a 
declaration must be sent to the Pfizer Pharmacovigilance department, or to its accredited representative, 
for all types of adverse events listed in the table above and occurring during this period. If the patient 
receives the test drug on the last day of the observation period, the notification period is extended by a 
further 28 calendar days after the end of the observation period. In most cases, the consent signature date 
corresponds to the date the patient is included in the study. 
In some cases, there may be a delay between the signing of the consent form and inclusion in the study. 
In cases where the patient gives his/her consent but is not included in the study (e.g.: the patient changes 
his/her mind concerning his/her participation; screening test failure), the notification period ends at the 
date of the decision not to include the patient. 
If the physician is made aware of a serious adverse event occurring at any time after the end of the 
observation period that he/she considers may be linked to the study medicine, this serious adverse event 
must also be declared to the Pfizer Pharmacovigilance department. 
 
Evaluation of causality 
The physician must assess and report the causal relationship. For all adverse events, sufficient information 
must be obtained by the physician to determine the causality of each adverse event. The physician must 
monitor those AEs considered to be related to the study medicine until the resolution or stabilisation of the 
event and/or its sequelae, at a level deemed acceptable by the physician, and Pfizer must agree with this 
evaluation. 
The evaluation of causality by the physician is the determination of the fact that there is a reasonable 
possibility that the study medicine caused or contributed to the adverse event. If the final determination of 
causality is "unknown" and if the physician is unable to determine whether the study medicine caused the 
event, then the event must be reported within 24 hours. 

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If the physician is unable to determine the aetiology of the event, but has determined that the study 
medicine is not the cause of the event, this fact must be clearly stated in the case report form and on the 
non-interventional study adverse event report form (NIS AEM Report Form). 
 
DEFINITION OF AN ADVERSE EVENT 
Adverse events 
An adverse event is an adverse manifestation occurring in a patient two whom a medicinal product has 
been administered. The event does not need to present a causal relationship with the treatment or use. 
Some examples if adverse events include, though this list is in no way restrictive:  
 Abnormal test results (see below for circumstances under which an abnormal test result 
constitutes an AE); 
 Clinically significant symptoms and signs; 
 Alteration of clinical examination results; 
 Hypersensitivity; 
 Lack of efficacy;  
 Drug abuse;  
 Drug dependence. 
Moreover, for medicines, they may include signs or symptoms resulting from: 
 Overdosage; 
 Weaning; 
 Misuse;  
 Off-MA (Marketing Authorisation) use;  
 Drug interactions; 
 Extravasation; 
 Exposure during pregnancy; 
 Exposure during breast feeding; 
 Medicinal error; 
 Occupational exposure. 
 
Abnormal test results 
The criteria used to determine whether an abnormal result for an objective test should be reported as an 
adverse event are as follows: 
 The test result associated with symptoms and/or 
 The test result requires additional diagnostic investigations, or a medical/surgical procedure and/or 
 The test result leads to a dosage change or withdrawal from the study, to the administration of a 
significant additional concomitant treatment, to another treatment and/or 
 The test result is considered as an adverse event by the physician or sponsor. 

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Simply repeating an abnormal test, failing any of the above-mentioned conditions, does not constitute an 
adverse event. An abnormal test result arising from an error does not need to be reported as an adverse 
event. 
 
Serious adverse events 
A serious adverse event is defined as an adverse manifestation in a patient receiving a medicinal product 
or nutritional product, at any dose, or using a medical device, and: 
 Causing the patient's death;  
 Creating a life-threatening situation; 
 Requiring the patient's hospitalisation or extension of hospitalisation (see below for circumstances 
under which this does not constitute an adverse event); 
 Causing permanent or major invalidity or disability (significant impairment in the ability to 
perform tasks of everyday life); 
 Leads to a congenital anomaly or malformation. 
 
The progression of the malignant disease during the study (including signs and symptoms of progression) 
must not be reported as a serious adverse event, except if the outcome is death during the study, or during 
the adverse event notification period. Hospitalisation due to signs and symptoms of disease progression 
should not be reported as a serious adverse event. If the malignant disease causes the patient's death during 
the adverse event notification period, then the event leading to death must be recorded as an adverse event, 
and as a grade 5 serious adverse event. 
 
An event shall be defined as a medically significant event based on a medical and scientific judgement. A 
medically significant event may not be immediately life-threatening and/or lead to death or 
hospitalisation. If, however, it is established that the event could represent a danger to the patient and/or 
require a procedure to avoid any of the aforementioned outcomes, the medically significant event must be 
reported as serious.  
For example, this category of medically significant events includes allergic bronchospasm requiring 
intensive care at the A&E department or at home, blood crasis disorders, convulsions not leading to 
hospitalisation, or the development of drug dependence or drug abuse. 
Moreover, any suspected transmission of an infectious agent, whether pathogenic or not, by a Pfizer 
product, is considered to be a serious adverse event. Suspicion of this event may be induced by clinical 
symptoms or examination results indicating infection in a patient exposed to a Pfizer product. The terms 
"suspected transmission" and "transmission" are considered to be synonymous. 
These cases are considered to be unexpected and must be managed as serious cases by the Pfizer 
Pharmacovigilance department. These cases may also where applicable be reported as product defects. 
Hospitalisation 
Hospitalisation is defined as any initial admission (even for periods of less than 24 hours) to a healthcare 
establishment, or any extension of admission. 
Admission also includes transfer, within the hospital, to an intensive care unit (e.g.: from the psychiatric 
unit to a medical unit, from the medical unit to a coronary care unit, or from the neurology unit to a 
tuberculosis treatment unit). 

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An A&E consultation does not necessarily constitute a hospitalisation; an event leading to an A&E 
consultation, however, must be considered as medically significant. 
Hospitalisation in the absence of adverse event does not constitute an adverse event in and of itself and 
requires no declaration. For example, the following reasons for hospitalisation, without AE, do not need to 
be declared:  
 Social admission (e.g.: the patient has nowhere to sleep) 
 Administrative admission (e.g.: for an annual examination) 
 Optional admission not associated with a triggering AE (e.g.: for a scheduled plastic surgery 
procedure) 
 Hospitalisation for observation, with no associated AE  
 Admission for the treatment of a re-existing ailment unrelated to the development of a new AE, or 
to aggravation of the pre-existing ailment (e.g.: for an examination following on from persistent 
biological anomalies pre-dating the treatment) 
 Admission scheduled by the protocol during the clinical study (e.g.: for a procedure required by 
the study protocol) 
Situations requiring declaration to the Pfizer Pharmacovigilance Department within 24 hours. 
Situations involving exposure during pregnancy or breast feeding, medication error, overdosage, misuse, 
extravasation, lack of efficacy or occupational exposure, are described below. 
Exposure during pregnancy (or exposure in utero) 
Exposure during pregnancy occurs if: 
1. A woman becomes pregnant or is found to be pregnant while receiving or exposed to a study 
medicine (e.g.: environmental exposure), or the woman becomes pregnant or is found to be 
pregnant after having interrupted and/or having been exposed to a study medicine (maternal 
exposure); 
 
2. An example of environmental exposure would be a case involving direct contact with a Pfizer 
product by a pregnant woman (e.g.: a nurse reports that she is pregnant and has been exposed to 
chemotherapeutic agents). 
 
3. A man has been exposed, in the context of a treatment or of environmental exposure, to a study 
medicine before or during the conception period and/or he was exposed during his partner's 
pregnancy (paternal exposure). 
As a general rule, cases of prospective and retrospective exposure during pregnancy, whatever the source, 
should be declared according to the serious adverse events declaration procedure, whether an associated 
adverse event is observed or not. 
If a female patient enrolled in the study, or the partner of a male patient in the study becomes pregnant or 
is found to be pregnant during the patient's treatment with the study medicine, the physician must declare 
this information to Pfizer, whether an adverse event is observed or not, by filling the non-interventional 
study adverse event report form, along with the supplemental "exposure during pregnancy" form. 
Moreover, the information concerning the environmental exposure to the study medicine by a pregnant 
woman (e.g.: a patient reports that she is pregnant and has been exposed to a cytotoxic product by 

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inhalation or by accidental spillage) must be declared to Pfizer, whether an associated adverse event 
occurs or not, by filling the non-interventional study adverse event report form, along with the 
supplemental "exposure during pregnancy" form. 
The information submitted must include the expected date of birth (see below for information concerning 
the date of birth). 
A follow-up should be implemented to obtain general information concerning the pregnancy. 
Moreover, a follow-up must be implemented to obtain information concerning the outcome of the 
pregnancy for all cases giving rise to a notification of exposure during pregnancy whose outcome is 
unknown.  
A pregnancy must be monitored to its term, or to its termination (e.g.: elective abortion) and Pfizer must 
be informed of the outcome.  
This information shall be provided as a follow-up to initial exposure during pregnancy report. In the case 
of a birth, the neonate's structural integrity can be ascertained at birth.  
In the event of termination of pregnancy, the reason must be specified and, if possible, the structural 
integrity of the foetus should be evaluated by visual inspection (unless the results of the tests conducted 
before the procedure suggested a congenital abnormality and that these results were declared). 
If the outcome of the pregnancy meets the criteria for an SAE (e.g.: ectopic pregnancy, spontaneous 
abortion, foetal death in utero, neonatal death, or congenital anomaly [for a living baby, an aborted foetus, 
foetal death in utero, or neonatal death]), the SAE declaration procedures must be observed. 
Additional information concerning the outcomes of pregnancies declared as SAEs are as follows:  
 Spontaneous abortion, including miscarriage and foetal retention; 
 Neonatal deaths occurring within one month of birth must be declared as SAEs, whatever the 
cause of death. Moreover, the death of an infant under the age of 1 month must be declared as an 
SAE when the physician considers that the infant's death is connected, or potentially connected, to 
exposure to the study medicine. 
Additional information concerning exposure during pregnancy may be requested. Follow-ups of outcomes 
after birth shall be dealt with on a case-by-case basis (e.g.: follow-up of premature babies to identify any 
development retardation). 
In the case of paternal exposure, a form for communicating information for pregnant partners shall be 
issued to the study participant for his partner. The issuing of this document to the study participant for 
transmission to his partner must be documented. 
Exposure during breast feeding 
Exposure situations during breast feeding must be reported, irrespective of whether an associated AE is 
observed. 
Exposure during breast feeding should not be notified when a Pfizer product specifically indicated for use 
in breast feeding women (e.g.: vitamins) is administered in accordance with MA. 
However, if the infant presents with an AE associated with the administration of such a medicinal product, 
the AE must be declared along with the exposure during breast feeding. 
Medication error 

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The term medication error refers to any unintentional error in the prescription, dispensing or 
administration of a medicinal product, that could cause or result in inappropriate use of a medicinal 
product or in harm to the patient, whereas he/she it is under the supervision of the healthcare professional, 
the patient or the consumer. These events may be linked to professional practice, products, procedures and 
systems, in particular: prescription; transmission of an order; product information, packaging and 
nomenclature; composition; delivery; distribution; administration; product training; surveillance and use.  
Medication errors include: 
 Quasi-accidents, whether directly involving a patient or not (e.g.: inadvertent/erroneous 
administration, which is the accidental use of a non-indicated product, or prescription by a 
healthcare professional or patient/consumer); 
 Confusion concerning the product name (e.g.: trade name, brand name). 
The participating physician must declare the following medication errors to Pfizer, irrespective of whether 
an associated AE/SAE is observed: 
 Medication errors involving patient exposure to the product, irrespective of whether the 
medication error is accompanied by an adverse event or not. 
 Medication errors not directly involving a patient (e.g.: potential medication errors or quasi-
accidents). When a medication error does not involve patient exposure to the product, the 
following minimum criteria constitute a case of medication error: 
- 
Identifiable notifier; 
- 
Suspicious product; 
- 
Medication error. 
Overdosage, Misuse, Extravasation 
Cases of overdosage, misuse and extravasation associated with the use of a Pfizer product must be 
declared to Pfizer by the participating physician, irrespective of whether or not an associated AE/SAE is 
observed. 
 
Lack of efficacy 
Cases of lack of efficacy of a Pfizer product must be declared to Pfizer by the participating physician, 
irrespective of whether or not an associated AE/SAE is observed, whatever the indication of the Pfizer 
product. 
Occupational exposure 
Cases of occupational exposure to a Pfizer product must be declared to Pfizer by the participating 
physician, irrespective of whether or not an associated AE/SAE is observed. 
11. PROPERTY AND COMMUNICATION OF RESULTS 
Pfizer shall remain the owner of all forms of case reports, data analyses and reports resulting from this 
study.  

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Any information obtained from this study shall be considered as confidential, until the analysis and final 
review, by Pfizer and the members of the scientific committee, have been completed.  
11.1. Communication and publication by Pfizer 
Pfizer will honour its commitment to publicly disclose the results of the clinical study by publishing them 
on www.clinicaltrials.gov, www.pfizer.com and/or the European clinical trials database (EudraCT), and 
other public registers, in accordance with applicable local laws/regulations 
11.2. Publication by participating physicians 
Pfizer does not object to the members of the scientific committee or participating physicians publishing 
the results of the study. To prevent the accidental disclosure of confidential information or industrial 
property, however, these results can only be published following revision and consent by Pfizer. Prior to 
publication or presentation, a copy of the final text must be sent by the members of the scientific 
committee or participating physicians to Pfizer for comments. Such comments will be intended to check 
the scientific content of the proposed publications and/or presentations and to ensure that the data and 
materials relating to Pfizer's products and activities are fairly, accurately and reasonably presented. 
The participating physicians will provide Pfizer with the articles, abstracts, or full text of any planned 
communications (posters, conference speeches, etc.) at least 30 days prior to submission for publication. If 
an action is required to protect intellectual property rights, the members of the scientific committee or the 
participating physician will accept to delay disclosure for a period not exceeding 60 additional days. 
The participating physician may request the deletion of any previously undisclosed confidential 
information (other than the study results) before new publication. 
If the study is multi-centric, the participating physician agrees that the first publication will be a joint 
publication covering all centres. If the document has not been submitted to all participating centres for 
publication 12 months after the end of the study however, the participating physician is free to publish 
independently, subject to the other provisions stipulated in this paragraph. 
All study-related publications must conform to ethics rules concerning copyright and publication,  
The publication of results shall also give rise to an article in the financial agreement between Pfizer and 
the participating physician and/or establishment. In this section, publication by participating physicians, 
the meaning of the defined terms is that specified in the agreement. 
 
 
 
12. SCIENTIFIC COMMITTEE 
12.1. Composition 
The scientific committee shall consist of the following members:  
PPD

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12.2. Role of the Scientific Committee  
The purpose of this committee is to validate the study protocol, the case report form (CRF and 
questionnaires), the results and analysis reports, along with all valuations (communications, publications). 
It shall also take part in implementing the therapy management platform and will validate the call 
scenario, physician compensation and team training. 
PPD

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13. REFERENCES 
1. 
Garber MC, Nau DP, Erickson SR, Aikens JE, Lawrence JB. The concordance of self-report with 
other measures of medication adherence: a summary of the literature. Medical care. 2004;42(7):649-52. 
Epub 2004/06/24. 
2. 
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported 
measure of medication adherence. Medical care. 1986;24(1):67-74. Epub 1986/01/01. 
3. 
Lipworth L, Tarone RE, McLaughlin JK. The epidemiology of renal cell carcinoma. The Journal 
of urology. 2006;176(6 Pt 1):2353-8. Epub 2006/11/07. 
4. 
Rini BI, Campbell SC, Escudier B. Renal cell carcinoma. The Lancet. 2009;373(9669):1119-32. 
5. 
Thuret R, Maurin C, Sun M, Perrotte P, Karakiewicz PI. [Treatment of metastatic renal cell 
carcinoma]. Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise 
d'urologie. 2011;21(4):233-44. Epub 2011/04/13. Traitement du carcinome renal metastatique. 
6. 
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA: a cancer 
journal for clinicians. 2011;61(2):69-90. Epub 2011/02/08. 
7. 
Pfaffenroth EC, Linehan WM. Genetic basis for kidney cancer: opportunity for disease-specific 
approaches to therapy. Expert opinion on biological therapy. 2008;8(6):779-90. Epub 2008/05/15. 
8. 
Eggener SE, Yossepowitch O, Pettus JA, Snyder ME, Motzer RJ, Russo P. Renal cell carcinoma 
recurrence after nephrectomy for localized disease: predicting survival from time of recurrence. Journal of 
clinical oncology : official journal of the American Society of Clinical Oncology. 2006;24(19):3101-6. 
Epub 2006/07/01. 
9. 
Janzen NK, Kim HL, Figlin RA, Belldegrun AS. Surveillance after radical or partial nephrectomy 
for localized renal cell carcinoma and management of recurrent disease. The Urologic clinics of North 
America. 2003;30(4):843-52. Epub 2003/12/19. 
10. 
Patard JJ, Tazi H, Bensalah K, Rodriguez A, Vincendeau S, Rioux-Leclercq N, et al. The changing 
evolution of renal tumours: a single center experience over a two-decade period. European urology. 
2004;45(4):490-3; discussion 3-4. Epub 2004/03/26. 
11. 
Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic 
stratification of 670 patients with advanced renal cell carcinoma. Journal of clinical oncology : official 
journal of the American Society of Clinical Oncology. 1999;17(8):2530-40. Epub 1999/11/24. 
12. 
Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative 
treatment for clinical trials of new therapies against advanced renal cell carcinoma. Journal of clinical 
oncology : official journal of the American Society of Clinical Oncology. 2002;20(1):289-96. Epub 
2002/01/05. 
13. 
Pouessel D, Culine S. Targeted therapies in metastatic renal cell carcinoma: the light at the end of 
the tunnel. Expert review of anticancer therapy. 2006;6(12):1761-7. Epub 2006/12/22. 
14. 
Molina AM, Jia X, Feldman DR, Hsieh JJ, Ginsberg MS, Velasco S, et al. Long-term response to 
sunitinib therapy for metastatic renal cell carcinoma. Clinical genitourinary cancer. 2013;11(3):297-302. 
Epub 2013/05/28. 
15. 
Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, et al. Pazopanib versus sunitinib in 
metastatic renal-cell carcinoma. The New England journal of medicine. 2013;369(8):722-31. Epub 
2013/08/24. 
16. 
Ravaud, A, et al. Real-life patterns of use and effectiveness of sunitinib in patients with metastatic 
renal cell carcinoma: The SANTORIN study. ASCO. 
 (suppl 6; abstr 400). 
17. 
Escudier B, Eisen T, Porta C, Patard JJ, Khoo V, Algaba F, et al. Renal cell carcinoma: ESMO 
Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of oncology : official journal 
of the European Society for Medical Oncology / ESMO. 2012;23 Suppl 7:vii65-71. Epub 2012/11/20. 

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18. 
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib 
versus interferon alfa in metastatic renal-cell carcinoma. The New England journal of medicine. 
2007;356(2):115-24. Epub 2007/01/12. 
19. 
Rini BI, Cohen DP, Lu DR, Chen I, Hariharan S, Gore ME, et al. Hypertension as a biomarker of 
efficacy in patients with metastatic renal cell carcinoma treated with sunitinib. Journal of the National 
Cancer Institute. 2011;103(9):763-73. Epub 2011/04/30. 
20. 
Donskov F, et al. ECCO-ESMO Congress 2011: Abstract 1141. 
21. 
Pusanov I, et al. ECCO-ESMO Congress 2011: Abstract 1444. 
22. 
Davis MP, et al. ECCO-ESMO Congress 2011: Abstract 1139. 
23. 
Mejean A, Lebret T. [Management of toxicities due to anti-angiogenic treatment of metastatic 
renal carcinoma]. Progres en urologie : journal de l'Association francaise d'urologie et de la Societe 
francaise d'urologie. 2008;18 Suppl 7:S315-9. Epub 2008/12/17. Gestion des toxicites des traitements 
cibles dans le traitement du cancer du rein metastatique. 
24. 
Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, et al. Safety and efficacy of 
sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. The lancet oncology. 
2009;10(8):757-63. Epub 2009/07/21. 
25. 
Coriat R, Boudou-Rouquette P, Durand JP, Forgeot d'Arc P, Martin I, Mir O, et al. Cost 
effectiveness of integrated medicine in patients with cancer receiving anticancer chemotherapy. Journal of 
oncology practice / American Society of Clinical Oncology. 2012;8(4):205-10. Epub 2012/11/28. 
26. 
Scotte F, Oudard S, Aboudagga H, Elaidi R, Bonan B. A practical approach to improve safety and 
management in chemotherapy units based on the PROCHE - programme for optimisation of the 
chemotherapy network monitoring program. European journal of cancer (Oxford, England : 1990). 
2013;49(3):541-4. Epub 2012/10/02. 
27. 
Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. The British 
journal of radiology. 1971;44(526):793-7. Epub 1971/10/01. 
28. 
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of 
randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. 
British journal of cancer. 1976;34(6):585-612. Epub 1976/12/01. 
29. 
Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. 
Lancet. 2005;365(9471):1657-61. Epub 2005/05/12. 
30. 
European Parliament and the Council. Directive 2001/20/EC on the Approximation of the Laws, 
Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good 
Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use.  2001. 
31. 
The International Society for Pharmacoepidemiology (ISPE). Good Pharmacoepidemiology 
Practice.  2007. 
32. 
World Medical Association. Declaration of Helsinki. Ethical principles for medical research 
involving human subjects.  Adopted by the WMA General Assembly in Helsinki (1964) and amended by 
the WMA General Assembly in Tokyo (1975), Venice (1983), Hong Kong (1989), Somerset West, South 
Africa (1996), and Edinburgh (2000), and clarified by the WMA General Assembly in Washington 
(2002), Tokyo (2004) and Seoul (2008); 2008. 
33. 
European Medicines Agency. Guidelines on good pharmacovigilance practices (GVP). 2013. 
  

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14. ANNEXES 
14.1. Appendix 1: Patient information and consent leaflet 
 
Patient information and informed consent 
letter  
Page: 
 1 of 5 
RENACALL STUDY 
 
Protocol no.: A6181213 
Date: 09/02/2017 
Room 
Language: French 
Centre no.: All centres 
Country: France 
Protocol title: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus 
standard follow-up  
Name of participating physician  
 
Physician's phone number 
Patient's name 
 
This document is a patient information and informed consent letter. It contains all the detailed explanations of the intermediate 
care study that you are invited to take part in, along with a consent form that you will be asked to sign should you agree to 
participate. 
I 
NATURE AND PURPOSE OF THE STUDY 
You have been invited to take part in a study on advanced/metastatic renal cell carcinoma called RENACALL "Evaluation of 
the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell 
carcinoma and receiving first line treatment with sunitinib" conducted by the Pfizer laboratory. 
This study will evaluate the impact of a therapy management platform in conjunction with standard care 
for patients suffering, like you, from advanced metastatic renal cell carcinoma and receiving 1st line 
treatment with sunitinib. 
This is multi-centre intermediate care study conducted in metropolitan France, with prospective data collection performed by 
the physician. All patients will be asked to fill in a compliance questionnaire and a satisfaction questionnaire concerning the 
therapy management platform.  
II  
PROJECT ORGANISATION 
Between 10 and 20 oncology centres, located in metropolitan France, will take part in this study. 
During the consultation marking the initiation of your sunitinib treatment, your physician will invite you to take part in this 
study. In all, 100 patients suffering from the same disease and receiving the same treatment as you (sunitinib) will be included 
in the study. 
This project is an intermediate care study, i.e. the patients having accepted to take part will be treated according to the 
physician's usual practices and, in addition, will benefit from platform-based follow-up. This latter shall consist in regular 
phone calls to accompany you in your real life home management of your treatment with sunitinib (prevention, advice and 
guidance of patients towards options). 
If you accept to take part, you will be included in the study and nurses will contact you according to a schedule defined in the 
protocol and reviewed with you during the first call.  
A 
STUDY PROCEDURES 
The protocol for this study involves monitoring you, at the most, during the first 4 cycles (i.e. 24 weeks) of your sunitinib 
treatment. If your physician or yourself deem necessary to continue follow-up by the therapy management platform nurse 
beyond these first 4 cycles, then you will be monitored until the end of treatment. 
The patient must be issued with a signed copy of this consent form 
 
Version approved by the XXXXXXX CPP dated XX/XX/XXXX. 
 
Patient's initials  
………….
. 

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Patient information and informed consent 
letter  
Page: 
2 of 5 
RENACALL STUDY 
 
Protocol no.: A6181213 
Date: 09/02/2017 
Room 
Language: French 
Centre no.: All centres 
Country: France 
Protocol title: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus 
standard follow-up  
Name of participating physician 
Physician's phone number 
Patient's name 
 
Your participation in this study would consist in: 
o 
accepting that your physician provide us with information concerning your health, without this information 
exceeding the scope of your health follow-up 
o 
accepting to be contacted by a therapy management platform nurse according to the following schema: 
 
o 
filling in a treatment compliance questionnaire 
o 
filling in a call centre-related satisfaction questionnaire at the end of the study or when treatment is stopped 
B 
EXPECTED DURATION AND EXPECTED NUMBER OF PATIENTS IN THE STUDY 
If you decide to take part in this study, you will be one of the 100 patients suffering from advanced/metastatic renal cell 
carcinoma treated with sunitinib and included by one of the centres in metropolitan France. 
The maximum duration of your participation in this study will be of 4 treatment cycles, i.e. 24 weeks. If your physician or 
yourself deem necessary to continue follow-up by the therapy management platform nurse beyond these first 4 cycles, then you 
will be monitored until the end of treatment. 
This study will not in any way alter your relationship with your physician, who will be able to prescribe any procedure or 
treatment he/she deems necessary over the coming consultations. 
 
C 
RESTRICTIONS ASSOCIATED WITH THE STUDY AND PATIENT INFORMATION 
This study does not comprise any restrictions that you must observe. 
Throughout the duration of the study, you will be covered by the insurance policy, taken out by the sponsor Pfizer, in 
accordance with current French legislation, should the study be detrimental to you. 
Details of the person to contact for additional information, or in the event of damages associated with the study: 
 
The patient must be issued with a signed copy of this consent form 
 
Version approved by the XXX CPP dated XX/XX/XXXX. 
 
Patient's initials  
………….
. 

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Patient information and informed consent 
letter  
Page: 
3 of 5 
RENACALL STUDY 
 
Protocol no.: A6181213 
Date: 09/02/2017 
Room 
Language: French 
Centre no.: All centres 
Country: France 
Protocol title: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus 
standard follow-up  
Name of participating physician 
Physician's phone number 
Patient's name 
 
SCIENTIFIC AND MEDICAL INFORMATION 
TEL. / +33 (0)1 58 07 34 40 
III 
RESPONSIBILITIES AND RIGHTS OF THE PATIENT AND CONFIDENTIALITY 
A 
STUDY TERMINATION 
The participating physician, i.e. the physician who has invited you to take part in this study, or the sponsor, may decide to 
terminate your participation in the study if: 
a) You fail to observe the participating physician's instructions 
b) You develop a serious ailment requiring the treatment to be stopped 
c) The study is stopped by the sponsor or by the health authorities.  
B 
RIGHTS 
Your participation in this study is completely free and voluntary. Take time to read this information leaflet and discuss the 
matter with your physician and family if you wish. Do not hesitate to ask your physician should you require any additional 
information. If you decide not to take part, or to withdraw from this study, for whatever reason, this will not in any way alter 
your relationship with the physician following you in the context of this study, or with your attending physician. Should you 
change your mind and decide to no longer participate in this study, you may request the destruction of all data pertaining to 
yourself. 
If you have any questions during the study, you should contact the physician following you in the context of this study. 
In accordance with current French legislation, the protocol describing the study in which you are taking part received a 
favourable pronouncement from the XXXX Committee for the Protection of Persons (CPP) dated XX/XX/XXXX. The 
purpose of this committee is to ensure the scientific relevance of the study, the conditions required for your protection and the 
observance of your rights. 
If you wish, your attending physician will be informed of your participation in this study. 
After analysing all data for all patients, you will be informed of the overall results of this study via the physician who follows 
you in the context of this study. 
C 
DATA CONFIDENTIALITY 
All medical files and documents related to this study that identify you will be strictly confidential and will not be disclosed to 
third parties, to the extent permitted by current law and/or regulations. The data collected pertaining to yourself, identified by a 
code number, will remain anonymous for the subsequent analysis of study results. If it is decided to communicate or publish the 
overall results of this study in the scientific literature, only anonymised data will be presented. 
The patient must be issued with a signed copy of this consent form 
 
Version approved by the XXX CPP dated XX/XX/XXXX. 
 
Patient's initials  
………….
. 

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Patient information and informed consent 
letter  
Page: 
4 of 5 
RENACALL STUDY 
 
Protocol no.: A6181213 
Date: 09/02/2017 
Room 
Language: French 
Centre no.: All centres 
Country: France 
Protocol title: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus 
standard follow-up  
Name of participating physician 
Physician's phone number 
Patient's name 
 
In the context of this study, you accept that appointed Health Authority representatives, Pfizer representatives, other physicians, 
nurses and individuals taking part in this study be allowed to access your medical files. You accept that these documents be 
communicated, under the above-described conditions, even if you decide to withdraw from this study. 
The data pertaining to yourself and recorded in the context of this study for epidemiological evaluation purposes, including 
those data concerning your lifestyle, will undergo computer processing by Pfizer or on its behalf. In accordance with act 78-17 
of 06 January 1978 on data protection, amended by act 2004-801 of 06 August 2004 on the protection of individuals with 
regard to the processing of personal data, you have the right to access and correct your data. You can exercise these rights at 
any time with the physician following you in the context of this study. 
Pfizer is the owner of the data and, as such, shall control their use and take all necessary steps to ensure their protection. 
 
IV 
COMPENSATION OF THE PARTICIPATING PHYSICIAN 
The participating physician, or hospital in which he/she practices, will receive financial compensation for this study from 
the sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
The patient must be issued with a signed copy of this consent form 
 
Version approved by the XXXX CPP dated XX/XX/XXXX. 
 
Patient's initials  
………….
. 

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Patient information and informed consent 
letter  
Page: 
5 of 5 
RENACALL STUDY 
 
Protocol no.: A6181213 
Date: 09/02/2017 
Room 
Language: French 
Centre no.: All centres 
Country: France 
Protocol title: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus 
standard follow-up  
Name of participating physician 
Physician's phone number 
Patient's name 
 
CONSENT TO PARTICIPATE IN THE STUDY
Dr. ………………….. invited me to take part in a study 
implemented by Pfizer on the treatment of metastatic renal 
cell carcinoma called "Evaluation of the impact of a 
therapy management platform on the management of 
patients suffering from advanced/metastatic renal cell 
carcinoma and receiving first line treatment with 
sunitinib, versus standard follow-up". 
I confirm that I am of legal age. 
I confirm that I am insured with a social security scheme, 
or the beneficiary of such a scheme. 
I have read and perfectly understood the above 
information. I was given the time and opportunity to ask 
any questions I may have had concerning the study and this 
form. 
I have read all the pages of this consent form and am aware 
of the risks and benefits described. 
I have been informed that I will be covered, during this 
study, by the insurance taken out by Pfizer the sponsor, in 
accordance with current French legislation. 
I have been notified that the data concerning myself will 
remain strictly confidential. I only allow Pfizer employees, 
their representatives, any service providers under contract 
to Pfizer, along with the various regulatory authorities to 
view these data, on condition that Pfizer undertakes to 
enforce their confidentiality, in accordance with act no. 78-
17 of 06 January 1978. 
I accept that the data recorded during this study may be 
subject to computer processing by or for Pfizer. I have 
noted that I can exercise my right of access and correction 
with Pfizer, stipulated by act no. 78-17 of 06 January 1978 
on data protection, amended by act no. 2004-801 of 06 
August 2004 on the protection of individuals with regard to 
the processing of personal data, via the physician following 
me for this study. 
I have been informed that I am free to accept or refuse 
participation in this study and to withdraw from the study 
at any time, without this affecting my relationship with my 
physician. My signing of this consent does not in any way 
release Pfizer from its responsibilities and I retain my full 
rights provided under the law. 
I accept that the result of the study be published and 
communicated to the concerned Authorities and to Pfizer. 
I freely accept to take part in this study under the 
conditions specified in this document. 
By signing this consent form, I confirm that all the 
information I have provided, in particular concerning my 
medical history, is to the best of my knowledge accurate. 
I have noted that I will receive a signed copy of this 
consent form.
.
The patient 
Patient's last name / first name in block capitals: 
--------------------------------------------------------------- 
Date: --------------------------------------- 
Patient's signature: 
 
 
 
 
The participating physician 
Participating physician's last name / first name in block 
capitals:  
Dr, Prof.: -----------------------------------------------------------
---- 
 
Date: --------------------------------------- 
Participating physician's signature:  
Sponsor PFIZER 
 
 
23-25, avenue du Dr Lannelongue 
 
 
75,668 PARIS Cedex 14 
 
The patient must be issued with a signed copy of this consent form 
 
Version approved by the XXX CPP dated XX/XX/XXXX. 
 
Patient's initials  
………….
. 

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14.2.  Appendix 2: Contact authorisation form 
Phone contact request form 
for the call centre  
 
 
Box to be filled in by the Physician:    
Study A6181213 - RENACALL 
 
► Centre no.: /…/…/…/…/ - Patient no.:/…/…/ 
 
 
 
 
 
 
 
 
► Date of patient inclusion in the study (D0): ………………………. 
 
 
► Physician's name: ………………………………………………….. 
 
 
 
► Physician's phone no.: ………………………………………………… 
 
► Physician's postal 
code: ………….. 
 
 
Box to be filled in by the Patient:  
 
I hereby give you my contact details, such that you can contact me in the context of this study. I have noted that you are bound by 
professional secrecy, that my contact details will not be provided to third parties, will not be used for purposes other than this study and 
will be destroyed, at the latest, at the end of this study. I authorise you to enter my contact details into a computer program to enable you 
to schedule and manage our contacts. In accordance with the Data Protection Act, I have the right to access and correct my contact details 
throughout the duration of the study. I can exercise this right via my physician. I remain free, at any time during the study, to request that 
you stop contacting me and to delete my contact details from your program, without having to justify myself.  
 
M.  Mrs    
Name: …………………………………………………..  
First name: 
…………………………………………………. 
Address:…………………………………………………………….………………………………………
…………… 
……………………………………………………………………………………………………….……
………………… 
 
……………………………………………………………………………………………………….……
………………… 
Preferred contact phone number (1 digit per box please): _ _ _ _ _ _ _ _ _ _ 
Other phone no. at which I can be contacted: _ _ _ _ _ _ _ _ _ _ 
 
 
 
 
Hours during which you are most likely to be able to contact me from Monday to Friday (tick the time slots): 
 

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8:30 to 10am  
 
10am to 12pm  
    12 to 2pm  
    2 to 4pm           4 to 6pm  
 6 to 8pm     
 
 
 
 
 
Date:  
 
 
 
 
Patient's signature: 
 
 
 
 
14.3. Appendix 3: ECOG 
ECOG Performance Status 
 
These scales and criteria are used by doctors and researchers to assess how a patient's disease is 
progressing, assess how the disease affects the daily living abilities of the patient, and determine 
appropriate treatment and prognosis. They are included here for health care professionals to access. 
 
 
 
 
ECOG PERFORMANCE STATUS* 
Grade ECOG 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, e.g., light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and 
about more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 
5 
Dead 
* As published in Am. J. Clin. Oncol.: 
Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: 
Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-
655, 1982. 
PPD

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The ECOG Performance Status is in the public domain therefore available for public use. To duplicate 
the scale, please cite the reference above and credit the Eastern Cooperative Oncology Group, Robert 
Comis M.D., Group Chair. 
 
 
 
 
 
 
 
14.4. Appendix 4: SPC 

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14.5. Appendix 5: Non-Inclusion Register 
 
 
 
Non-inclusion register 
 
 
 
PURPOSE OF THE NON-INCLUSION REGISTER 
The non-inclusion register serves to compare patients to be included in the RENACALL study with 
eligible patients who have not been included. 
This comparison is used to evaluate inclusion biases and thus to measure their impact on the 
representativeness of the studied population. 
Consequently, the statistical results will be fully usable and publishable. 
 
INSTRUCTIONS FOR FILLING IN THE NON-INCLUSION REGISTER 
The non-inclusion register should be filled in during the RENACALL study inclusion period, for all adult 
patients meeting the inclusion and non-inclusion criteria, but who did not wish to take part in the study. 
 
We remain available to answer any questions on: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The data collected in this document are declared to CNIL. By application of the provisions of articles 34 and subsequent of the amended "Data protection 
act" of January 6th 1978, you have a right of access, correction and deletion via the Pfizer laboratory. 
PPD

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CHARACTERISTICS OF PATIENTS NOT INCLUDED IN THE STUDY 
CENTRE NO. |__|__|__|__| 
 
 
 
Year of birth 
Gender 
ECOG performance 
status 
Reason for non-inclusion 
1. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
2. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
3. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
4. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
5. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 Patient refusal 
 Other, specify: __________________ 

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Year of birth 
Gender 
ECOG performance 
status 
Reason for non-inclusion 
 3 
 4 
6. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
7. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
8. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
9. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
10. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 

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11. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
12. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
13. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
14. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
15. 
|_|_| / |_|_|_|_|   
month  year 
 Man 
 Woman 
 0 
 1 
 2 
 3 
 4 
 Patient refusal 
 Other, specify: __________________ 
Please enter the date and electronically sign  
the non-inclusion register: 

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Date: |___|___||___|___||_2_|_0_|___|___|  
 
 
 
 

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14.6. Appendix 6: Case report form 
 
 
 
 
A6181213 
 
RENACALL STUDY 
 
Pragmatic evaluation of the impact of a therapy 
management platform on the management of 
patients suffering from advanced/metastatic 
renal cell carcinoma and receiving first line 
treatment with sunitinib, versus standard 
follow-up  
 
 
 
C A S E  R E P O R T  F O R M  
 
 
Centre identifier   
 
Patient identifier   
 
 
 
 
 

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1 PATIENT INCLUSION AND FOLLOW-UP SCHEMA 
 
 
 
Verification of inclusion criteria by the investigator 
Patient information/consent by patient's initials and signature on the consent form 
Connection to the e-CRF module and e-CRF data input 
 
 
 
Therapy management platform call scheme 
 
 
 
 
 
 

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2 INCLUSION VISIT 
Inclusion visit date:  /  / 20 (DD/MM/YYYY) 
Date of consent signing:  /  / 20 (DD/MM/YYYY) 
DEMOGRAPHIC CHARACTERISTICS 
Month and year of birth 
 
 /  (mm/yyyy)           
Gender  
 
 Male  
2                       
 
 
 Female 
2.1 Verification of eligibility criteria 
INCLUSION CRITERIA 
Patient suffering from advanced/metastatic renal cell carcinoma, receiving sunitinib first-
line treatment, as per SPC recommendations 
 Yes 
 No 
Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic 
effects due to radiotherapy or surgical procedure prior to initiation of sunitinib; 
 Yes 
 No 
Man or woman aged 18 or over 
 Yes 
 No 
Patient who can be monitored for 6 months 
 Yes 
 No 
Female patient of child-bearing age using a form of contraception during treatment with 
Sunitinib and for at least 28 days after termination of treatment with Sunitinib; 
 Yes 
 No 
Patient having signed his/her consent form; 
 Yes 
 No 
Patient affiliated with a social security scheme.  
 Yes 
 No 
A single "no" to one of the criteria negates the patient's eligibility for the study 
NON-INCLUSION CRITERIA 
Patient participating in a clinical trial during sunitinib treatment 
 Yes 
 No 
Patient managed by a home hospitalisation service during sunitinib treatment 
 Yes 
 No 
Patient taking part in therapeutic education programmes, or benefiting from nursing 
consultation, or from any other significant treatment support and likely to impact adverse 
event management. 
 Yes 
 No 
Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation  
 Yes 
 No 
Patient refusing the use of his/her personal data 
 Yes 
 No 
Patient with an ECOG performance status upon inclusion > 2; 
 Yes 
 No 
Serum creatinine > 1.5 times the upper normal limit 
 Yes 
 No 
Patient presenting with a bilirubin level > 2 mg/dl, aspartate transaminase (ASAT) or 
alanine transaminase (ALAT) ≥2.5 times the upper limit of the normal value, or ≥5 times 
the upper limit of the normal value in the presence of liver metastases upon initiation of 
sunitinib treatment; 
 Yes 
 No 
Patients who are staff members of a centre involved in the study, or close to one of the 
 Yes 
 No 

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staff members of a centre directly involved in conducting the study, or patients employed 
by Pfizer and involved in conducting the study 
A single "yes" to one of the criteria negates the patient's eligibility for the study 
2.2 Contact form    
Please fill in the contact form below and return it to the logistics centre.  
 M.        Mrs 
Name: ______________ 
First name: ___________ 
Phone no. 1: ________________       Phone no. 2 (optional): ________________ 
Preferred call times:  9am-12pm     12-2pm       2-5pm    5-7pm 
Display: Print pre-completed contact form button 
 
2.3 Patient characteristics upon initiation of sunitinib treatment 
Month and year of birth (mm/yyyy) 
 
 /   
Gender  
 
 
 Male  2 
 
 
 
 
 Female 
Weight  : , kg 
 
 
Height:   cm             BMI: , (auto) 
ECOG:  Yes        No 
 
If yes,  Date: 
 /  /  (DD/MM/YYYY) 
 
If yes, score:  
 0 
  1 
  2 
  3  
  4 
e-CRF instruction: a link shall be added allowing the physician to view the score variables  
Karnofsky score:  Yes        No 
If yes,  Date: 
 /  /  (DD/MM/YYYY) 
 
If yes, score: 
 100%          90% - 80%      70% - 60%      50% - 40%        30% - 10%       0% 
e-CRF instruction: a link shall be added allowing the physician to view the score variables 
Risk score - Criteria of Heng et al.: 
 
 Good                                      Poor  
 
 Intermediate                         Not available 
Number of risk factors: 0 = Good; 1 to 2 = Intermediate; 3 to 6 = Poor.  
e-CRF instruction: a link shall be added allowing the physician to view the risk score variables 

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2.4 History of the disease 
Description of the primitive kidney cancer 
Date of initial diagnosis 
 
 
 
 /  /   (DD/MM/YYYY or MM/YYYY) 
(anatomopathology report) 
Histology 
 
 Clear cell carcinoma 
 
 
 
 Tubulopapillary carcinoma, specify: 
 
 
 
 
 Type I 
 
 
 
 
 Type II 
 
 
 
 Chromophobe cell carcinoma 
 
 
 
 Other, specify: _____________________________ 
 
 
Mixed tumour?  Yes 
 No 
If Yes, specify the dominant tumour: ___________________ 
Stage of the disease - TNM classification 
 
 
 
 T0 
 T1 
 T2 
 T3 
 T4 
 Tx 
 
 
 
 N0 
 N1 
 N2 
 Nx 
 
 
 
 M0 
 M1 
 Mx  
Furhman grade 
 
 
 
 I 
  II  
 III  
 IV 
Description of the primitive kidney cancer treatment  
Nephrectomy: 
 Yes 
  No 
Radiotherapy:  Yes 
 
 No 
Other:   
    Yes  No 
 
If yes, 
specify: _______________________ 
Description of the metastatic renal cell carcinoma  
Is the renal cell carcinoma metastatic?  
 Yes  
 No 
If yes,  Date of appearance first metastases:  
// (DD/MM/YYYY or MM/YYYY) 
 
Number of different metastatic sites currently affected:  
Give the locations of the metastases: 
Lung   
 
 Yes  No 
 Blank 
Bone        
 
 
 
 
 Yes  No 
 Blank 
Mediastinum 
 
 
 Yes  No 
 Blank 
Liver   
 
 
 Yes  No 
 Blank 
Retroperitoneal lymph node  
 
 Yes  No 
 Blank 
Subclavian lymph node 
 
 Yes  No 
 Blank 
Adrenal gland 
 
 
 Yes  No 
 Blank 
Nephrectomy compartment 
 
 Yes  No 
 Blank 
Kidney   
 
 
 Yes  No 
 Blank 
Brain   
 
 Yes  No 
 Blank 
Skin 
  
 
 
 Yes  No 
 Blank 
Peritoneum 
 
 
               Yes  No 
 Blank 
Gastrointestinal                                 Yes 
 No 
 Blank 

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Pancreatic                                               Yes   No  Blank 
Skin                                                       Yes  No 
 Blank 
Other 1   
 
                   Yes No 
 Blank 
Other 2                                                 
 
 ≤ Not specified 
  
If yes, please specify: __________________________ 
 
2.5 Medical history and co-morbidities at the time of the inclusion visit 
Former or current co-morbidities?  Yes 
 No 
Diabetes  
 
  
 Yes  No   if yes, specify current:  Yes 
 No 
 
 Current treatment:  Yes 
 No 
Thyroid 
  
  
 Yes  No  If yes, specify    Hypothyroidism   
Hyperthyroidism 
 Specify current:  Yes  No 
 
 Current treatment:  Yes 
 No 
 
CerebroVascular Accident (stroke)   Yes  No  if yes, year:  (YYYY)  
 Current treatment:  Yes 
 No 
 
Hypertension 
 
 Yes  No  if yes, specify current:  Yes 
 No 
 Current treatment:  Yes 
 No 
 
If yes, year initiated:  (YYYY) 
 
Myocardial infarction  
 
 Yes  No  if yes, year:  (YYYY) 
 Current treatment:  Yes 
 No 
 
Deep vein thrombosis 
  Yes  No  if yes, specify current:  Yes 
 No 
 Current treatment:  Yes 
 No 
 
Angina pectoris 
 
 Yes  No  if yes, specify current:  Yes 
 No 
 Current treatment:  Yes 
 No 
 
Kidney failure  
 
 Yes  No  if yes, specify current:  Yes 
 No 
 Current treatment:  Yes 
 No 
 
Liver failure 
 
 Yes  No  if yes, specify current:  Yes 
 No 
 Current treatment:  Yes 
 No 
 
Other 
 
                           Yes 
 No  if yes, specify _______________________ 
 specify current:  Yes  No 
 Current treatment:  Yes 
 No 
 

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2.6 Haematological and biochemical profile prior to sunitinib initiation 
 
Please fill in the following table: 
Date of biological examination:  /  / 20 (DD/MM/YYYY) 
Haematological profile 
Parameters  
Value obtained 
Value 
Unit 
Haemoglobin  
 Yes     No  Not 
performed 
 
 g/dL  
 Other If other, specify: ___ 
Neutrophils 
 Yes     No  Not 
performed 
 
 /mm3  
 Other If other, specify: ___ 
Platelets 
 Yes     No  Not 
performed 
 
 109/L  
 Other If other, specify: ___ 
Biochemical profile 
Parameters  
Value obtained 
Value 
Unit 
Creatinine 
 Yes     No  Not 
performed 
 
 mg/dL 
 Other If other, specify: ___ 
ALAT (GPT) 
 Yes     No  Not 
performed 
 
 U/L 
 Other If other, specify: ___ 
ASAT (GOT) 
 Yes     No  Not 
performed 
 
 U/L 
 Other If other, specify: ___ 
Total bilirubin 
 Yes     No  Not 
performed 
 
 mg/dL 
 Other If other, specify: ___ 
Calcium 
 Yes     No  Not 
performed 
 
 mmol/L  
 Other If other, specify: ___ 
Albumin 
 Yes     No  Not 
performed 
 
 g/L  
 Other If other, specify: ___ 
LDH 
 Yes     No  Not 
performed 
 
 UI/L  
 Other If other, specify: ___ 
Were abnormal values of other biological parameters observed (last available examination)?  Yes  No 
Parameters 
Value obtained 
Abnormal 
result 
For abnormal 
results, value 
Unit 
Haematology 
Haematocrit 
 Yes     No  
Not performed 
 Yes No 
 
 % 
 Other If other, specify: ___ 
White blood 
cells 
 Yes     No  
Not performed 
 Yes No 
 
 109/L  Other If other, specify: 
___ 
Biochemistry 
Alkaline 
phosphatase 
 Yes     No  
Not performed 
 Yes No 
 
 U/L 
 Other If other, specify: 
___ 
TSH 
 Yes     No  
Not performed 
 Yes No 
 
 mU/L 
 Other If other, specify: 
___ 
fT3 
 Yes     No  
Not performed 
 Yes No 
 
 pmol/L 
 Other If other, specify: 
___ 

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fT4 
 Yes     No  
Not performed 
 Yes No 
 
 pmol/L 
 Other If other, specify: 
___ 
Sodium 
 Yes     No  
Not performed 
 Yes No 
 
 mmol/L  Other If other, specify: 
___ 
Potassium 
 Yes     No  
Not performed 
 Yes No 
 
 mmol/L  Other If other, specify: 
___ 

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2.7 Other examinations 
Arterial blood pressure 
Examination:  
 Yes        No  
 
 
If yes, examination date:  /  /  (DD/MM/YYYY) 
 
 
If yes, specify values:  /  mmHg 
 
 
 
 
 
           syst. 
diast. 
 
Electrocardiogram (ECG) 
Electrocardiogram: 
 Yes        No  
 If yes, Date :  /  /  (DD/MM/YYYY) 
 
Normal result:  
 Yes        No  if abnormal, specify: 
 
 
 
 
 
 
 Atrial fibrillation (AF) 
 
 
 
 
  
 Ventricular arrhythmia  
 
 
 
 
 
 
 Atrioventricular block (AV block) 
 
 
 
 
 
 
  Other, specify: _________________ 
 
Echocardiography 
Echocardiography: 
 Yes        No  
  If yes, Date:  /  /  (DD/MM/YYYY) 
 
Normal result:   Yes        No  if abnormal, specify: _______________________________ 
 
 
Oral examination 
 Yes   
 No 
Oral examination:           Yes  
 No 
 If yes, Date :  /  /  (DD/MM/YYYY) 
 If yes, Result:  Normal  
 Abnormal 
 

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2.8 Initiation of Sunitinib first line treatment 
Initiation of sunitinib treatment 
Date of first day of cycle 1:  /  /  (DD/MM/YYYY) 
 
Dose and dosage regimen:  
 50 mg/day, 4 weeks followed by a 2-week break 
 
 
2.9 Symptomatic or preventive treatments 
Symptomatic or preventive treatments prescribed during the initial visit 
Prescription of an anti-emetic treatment:   
 Yes 
 No 
Prescription of an anti-diarrhoeal treatment:  
 Yes 
 No 
Initiation of anti-neutropenic treatment  
 
 Yes 
 No 
Prescription of an anti-hypertensive treatment:  
 Yes 
 No 
Prescription of mouth washes and local anaesthetics:  
 Yes 
 No 
Prescription of emollients, moisturising creams:  
 Yes 
 No 
Prescription of analgesics:                                                           Yes 
 No 
Prescription of an anti-gastro-oesophageal reflux treatment:       Yes 
 No 
Bisphosphonate treatment:                                                       Yes 
 No 
Other anti-tumour treatment:                                         Yes  No 
            If yes, specify: ______________________________________________________ 
Other prescriptions:                                                         
 Yes 
 No 
            If yes, specify: ______________________________________________________ 
e-CRF instruction: 'Please send an anonymised copy of available prescriptions issued to the patient after the
inclusion visit to the logistics centre, to enable the therapy management platform nurses to advise the patien
Each prescription must comprise the patient's participation no.'  
  
2.10 Sunitinib treatment accompanying measures 
The information received by the patient upon sunitinib treatment initiation (several boxes possible) was 
provided: 
                 
 by yourself   
  by the care team. Specify the type of individuals involved (nurse, intern, etc.) 
__________________________ 
       
 by means of an information leaflet or any other medium / material / document issued to 
the patient: 
 Specify the medium: ____________________ 
                        other:  __________________________________________________________ 

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3 FOLLOW-UP VISIT - ROUTINE END-OF-CYCLE CONSULTATIONS 
Identical follow-up data collection by the physician for all three visits: W6, W12 and W24. 
 
 
Follow-up visit date:  /  / 20 (DD/MM/YYYY) 
 
Scheduled cycle end date:  /  / 20 (DD/MM/YYYY) 
 
 
3.1 Tumour evaluation 
Has a tumour evaluation been carried out since the last visit dated [date of last recorded visit]:  Yes 
       No 
 
If yes, examination date:  /  /  (DD/MM/YYYY) 
 
X-ray examination (several choices possible) performed to determine tumour progression: 
 
 Scan           
 MRI  
 PET scan 
 X-ray  Echography 
 
Response to treatment according to participating physician, according to RECIST v1.1 criteria 
 
 
 CR (complete response) 
 
 
 
 PR (partial response) 
 
 
 
 
 SD (stable disease) 
 
 
 PD (progressive disease) 
 
 
 
 
 NA (not assessable) 
 
Reason:   
 
 
 
 
 
 
3.2 Clinical parameters 
ECOG:  Yes 
       No 
 
If yes,  Date: 
 /  /  (DD/MM/YYYY) 
If yes,  
Score:  0       1   2 
  3  
  4 
e-CRF instruction: a link shall be added allowing the physician to view the score variables 
Karnofsky score:  Yes        No 
If yes,  Date: 
 /  /  (DD/MM/YYYY) 
 
If yes, score: 
 100% 
  90% - 80% 
 70% - 60% 
 50% - 40%  
 30% - 10% 
 0% 
e-CRF instruction: a link shall be added allowing the physician to view the score variables 
Arterial blood pressure 
Examination:  
 Yes        No  
 
 
If yes, examination date:  /  /  (DD/MM/YYYY) 
 
 
If yes, specify values:  /  mmHg   (syst./ diast.) 

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3.3 Haematological and biochemical examination since last visit 
Please fill in the following table: 
Date of biological examination:  /  / 20 (DD/MM/YYYY) 
 
Haematological profile 
Parameters  
Value obtained 
Value 
Unit 
Haemoglobin  
 Yes     No  Not 
performed 
 
 g/dL  
 Other If other, specify: ___ 
Neutrophils 
 Yes     No  Not 
performed 
 
 /mm3  
 Other If other, specify: ___ 
Platelets 
 Yes     No  Not 
performed 
 
 109/L  
 Other If other, specify: ___ 
Biochemical profile 
Parameters  
Value obtained 
Value 
Unit 
Creatinine 
 Yes     No  Not 
performed 
 
 mg/dL 
 Other If other, specify: ___ 
ALAT (GPT) 
 Yes     No  Not 
performed 
 
 U/L 
 Other If other, specify: ___ 
ASAT (GOT) 
 Yes     No  Not 
performed 
 
 U/L 
 Other If other, specify: ___ 
Total bilirubin 
 Yes     No  Not 
performed 
 
 mg/dL 
 Other If other, specify: ___ 
Calcium 
 Yes     No  Not 
performed 
 
 mmol/L  
 Other If other, specify: ___ 
Albumin 
 Yes     No  Not 
performed 
 
 g/L  
 Other If other, specify: ___ 
LDH 
 Yes     No  Not 
performed 
 
 UI/L  
 Other If other, specify: ___ 
Were abnormal values of other biological parameters observed (last available examination)?  Yes  No 
Parameters 
Value obtained 
Abnormal 
result 
For abnormal 
results, value 
Unit 
Haematology 
Haematocrit 
 Yes     No  
Not performed 
 Yes No 
 
 % 
 Other If other, specify: ___ 
White blood 
cells 
 Yes     No  
Not performed 
 Yes No 
 
 109/L  Other If other, specify: ___ 
Biochemistry 
Alkaline 
phosphatase 
 Yes     No  
Not performed 
 Yes No 
 
 U/L 
 Other If other, specify: 
___ 
TSH 
 Yes     No  
Not performed 
 Yes No 
 
 mU/L 
 Other If other, specify: 
___ 
fT3 
 Yes     No  
Not performed 
 Yes No 
 
 pmol/L 
 Other If other, specify: 
___ 

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fT4 
 Yes     No  
Not performed 
 Yes No 
 
 pmol/L 
 Other If other, specify: 
___ 
Sodium 
 Yes     No  
Not performed 
 Yes No 
 
 mmol/L  Other If other, specify: 
___ 
Potassium 
 Yes     No  
Not performed 
 Yes No 
 
 mmol/L  Other If other, specify: 
___ 
3.4  Symptoms and tolerance since last visit 
Since the last visit dated [date of last recorded visit], has the patient presented with:  
Skin reactions or disease: 
 Yes  No 
If yes, how many episodes:  
Digestive disorders:   Yes 
 No If yes, how many episodes:  
Heart disorders: 
 Yes 
 No If yes, how many episodes:  
Haemorrhagic disorders: 
 Yes  No 
If yes, how many episodes:  
Haematological disorders:  
 Yes  No 
If yes, how many episodes:  
Infections:  
 Yes 
 No If yes, how many episodes:  
Pains:     
 
 Yes  No 
If yes, how many episodes:  
If yes, specify the location: ______________________ 
Endocrine disorders:         
 Yes  No 
If yes, how many episodes:  
Inflammatory disorders (mucositis, etc.) 
 Yes  No 
If yes, how many episodes:  
General symptoms (asthenia, anorexia, etc.)  
 Yes  No 
If yes, how many episodes:  
Occurrence of other adverse events  
 Yes  No 
If yes, how many episodes:  
If yes, specify: ______________________ 
 
e-CRF instruction:  Pharmacovigilance form: Each time a table row is validated, the participating physician 
is directed to a form to be filled in. 
Description of the adverse effect:  
Type 
of 
even
t 
Descripti
on of the 
event 
Start 
date 
Severity 
Grade 
(CTCAE 
v4.03) 
Impact on 
activities of 
daily living: 
Causal 
relationshi
p 
Change 
Corrective 
medical action 
Last action 
performed on 
Sutent® during 
the adverse 
event  
Overview of all previous AEs (e-CRF + CATI) and follow-ups 
In the instructions for completing the AE report form, insist on:  
'please give a precise description of the event, its duration, its impact on the patient's life, the corrective measures 
implemented and any medical procedures required: medical consultation, A&E department, hospitalisation'  
'please evaluate the degree of severity of this case according to CTCAE v4.03 (June 2010)' 
'please fill in the adverse event report form for all AEs, whether serious or not, whether associated with the 
sunitinib treatment or not' 

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(auto
) 
 
……
…….. 
……
…….. 
……
…….. 
--/--
/-- 
(DD/
MM/
YYY
Y) 
 
 Non-serious 
 Serious 
If serious, severity criteria 
(several possible answers):  
 Caused death 
If death, specify:  
Date of death: --/--/---- 
(DD/MM/YYYY) 
Cause of death: ______ 
 Life-threatening 
 Hospitalization / 
prolonged hospitalization 
 Anomaly / congenital 
malformation 
 Permanent or major 
invalidity or disability 
 Medically significant 
event 
 Grade 1    
 Grade 2    
 Grade 3    
 Grade 4 
 Grade 5    
 
  Does not 
affect daily life 
 Makes 
certain actions 
difficult to 
accomplish 
 Affect 
activities of 
daily life 
 Related 
to taking 
Sutent® 
 Related 
to a 
concomitan
t medicine 
If other, 
specify the 
treatment  
___ 
 Recovered  
If recovered, 
recovery date: 
--/--/--
(DD/MM/YY
YY) 
 Recovered 
with sequelae 
If recovered, 
recovery date: 
--/--/--
(DD/MM/YY
YY) 
 
 Recovering 
 Not 
recovered 
 Unknown 
 Prescription of a 
treatment, specify:  
 Medical 
consultation 
(general 
practitioner, 
specialist, 
emergency 
department) 
→§3.7 
 Hospitalisation. 
→§3.7 
  Other, specify:  
 Not applicable 
 Interruption 
(temporary, 
permanent, or 
delayed) 
If causality = 
Sutent®, →§3.5 
 Dose reduction 
If causality = 
Sutent®, →§3.5 
 Dose increase 
If causality = 
Sutent®, →§3.5 
 Dose 
unchanged 
 Unknown  
 Not applicable 
 (Dynamic table: auto-incrementation of the number of rows displayed according to the number of AEs declared above. The 
table is shared with that of AEs declared by the nurses using the CATI system). 
 
3.5 Conditions of use of the sunitinib treatment 
Has the sunitinib dose and/or dosage regimen been changed since the last documented visit dated [date of last 
recorded visit], including during the day's follow-up visit?  
 Yes  No   
If yes, describe all modifications observed:  
Date 
Change of 
dose 
If yes, new dose 
(mg/day) 
Change of 
dosage regimen 
If yes, new 
regimen 
Reason for 
the 
modificatio
n 
 /  / 
  
(DD/MM/YYYY) 
 Yes 
 No 
 25  
 37.5 
 50 
 62.5 
 75   Other: 
 
 Yes 
 No 
: 
__________
____ 
 AE; If 
yes, specify 
which one: 
___ 
* 
 Other, 
specify:   
 /  / 
  
(DD/MM/YYYY) 
 Yes 
 No 
 25  
 37.5 
 50 
 62.5 
 75   Other: 
 
 Yes 
 No 
: 
__________
____ 
 AE; If 
yes, specify 
which one: 
___ 
 
 Other, 
specify:   
(Dynamic table: rows can be added if more than two modifications are observed) 
*: If AE ticked, the physician has already described this AE in the previous section, the e-CRF will thus display the list of 
AEs already filled in and the physician can simply select the relevant AE (without having to describe it again) 
Has the sunitinib treatment been temporarily interrupted since the last documented visit dated [date of last 
recorded visit], including during the day's follow-up visit?  Yes 
 No  

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If yes, describe each interruption: 
Date 
Duration 
If yes, reason for interruption 
 /  / 
  
(DD/MM/YYYY) 
 days 
 Ongoing 
 AE*; If yes, specify which one: ___ 
 
 
 
 Radiotherapy  
 Surgery  
 
 
 Other, specify:  
 
 
 /  / 
  
(DD/MM/YYYY) 
 days 
 Ongoing 
 AE; If yes, specify which one: ___ 
 
 
 
 Radiotherapy  
 Surgery  
 Other, specify:  
 
 
(Dynamic table: rows can be added if more than two modifications are observed) 
*: If AE ticked, the physician has already described this AE in the previous section, the e-CRF will thus display the list of 
AEs already filled in and the physician can simply select the relevant AE (without having to describe it again) 
 
3.6 Concomitant treatments  
 
Have any symptomatic or preventive treatments been added since the last visit dated [date of last 
recorded visit] (including the current visit for the next cycle)?      Yes 
 No 
If yes, please specify the prescriptions: 
Symptomatic or preventive treatments prescribed since the last visit 
Prescription of an anti-emetic treatment:   
 Yes 
 No 
Prescription of an anti-diarrhoeal treatment:  
 Yes 
 No 
Initiation of anti-neutropenic treatment  
 
 Yes 
 No 
Prescription of an anti-hypertensive treatment:  
 Yes 
 No 
Prescription of mouth washes and local anaesthetics:  
 Yes 
 No 
Prescription of emollients, moisturising creams:  
 Yes 
 No 
Prescription of analgesics:                                                           Yes 
 No 
Prescription of an anti-gastro-oesophageal reflux treatment:       Yes 
 No 
Bisphosphonate treatment:                                                        Yes 
 No 
Other anti-tumour treatment:                                       
 Yes 
 No 
            Specify: ______________________________________________________ 
Other prescriptions:                                                         
 
 Yes 
 No 
            Specify: ______________________________________________________ 
 
e-CRF instruction:   
'Please send an anonymised copy of the available prescriptions issued to the patient after the day's visit to t
logistics centre, to enable the therapy management platform nurses to advise the patient. Each prescription

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comprise the patient's participation no.'  
  

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3.7 Scheduled and unscheduled medical procedures  
History of calls to a healthcare professional during the previous cycle 
Has the patient contacted a healthcare professional since the last documented visit dated [date of last recorded visit], 
excluding any cases of adverse event?   Yes 
 No  
If yes, please fill in the following table for each new call to a healthcare professional: 
Date 
Type of call 
Specialist field 
of the healthcare 
professional 
Reason for the call 
Action implemented 
 /  / 
 
(DD/MM/YYYY) 
 Scheduled  
 Unscheduled 
List {General 
practitioner; 
Oncologist; 
Cardiologist; 
Nephrologist; 
Accident and 
Emergency; 
Nurse;  
Other, etc.} 
 AE*; If yes, 
specify which one: 
___ 
  
 Other, specify: 
______ 
 Temporary Sutent® interruption 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending physician 
 Emergency department.  
       Date: ________  
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
         Date: ________ 
         Location: ________ 
 Hygiene and nutrition advice 
 Other, specify: _________ 
 Not applicable 
(Dynamic table: rows can be added if more than two consultations are observed) 
 *: If AE ticked, the physician has already described this AE in the previous section, the e-CRF will thus display the list of AEs 
already filled in and the physician can simply select the relevant AE (without having to describe it again) 
History of consultations with a healthcare professional during the previous cycle 
Has the patient consulted a healthcare professional since the last documented visit dated [date of last recorded visit], 
excluding any cases of adverse event?  Yes 
 No  
If yes, please fill in the following table for each new consultation with a healthcare professional: 
Date 
Type of 
consultation 
Specialist field 
of the healthcare 
professional 
Reason for 
consultation 
Action implemented 
 /  / 
 
(DD/MM/YYYY) 
 Scheduled  
 Unscheduled 
List {General 
practitioner; 
Oncologist; 
Cardiologist; 
Nephrologist; 
Accident and 
Emergency; 
Nurse; 
Other, etc.} 
 AE*. If yes, 
specify which one: 
___  
 
  
 Other, specify: 
________ 
 Sutent® dose modification 
 Temporary Sutent® interruption 
 Termination of Sutent® 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending physician 
 Emergency department.  
       Date: ________  
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
         Date: ________ 
         Location: ________ 
 Hygiene and nutrition advice 
 Other, specify: _________ 
 Not applicable 
(Dynamic table: rows can be added if more than two consultations are observed) 

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*: If AE ticked, the physician has already described this AE in the previous section, the e-CRF will thus display the list of AEs 
already filled in and the physician can simply select the relevant AE (without having to describe it again) 
History of hospitalisations during the previous cycle 
Has the patient been hospitalised since the last documented visit dated [date of last recorded visit], excluding any cases 
of adverse event?  
 Yes  No  
If yes, please fill in the following table for each new hospitalisation:   
Date 
Type of 
hospitalisation 
Duratio
n 
Location 
Reason 
Action implemented 
 /  / 
 
(DD/MM/YY
YY) 
 Scheduled  
 Unscheduled 
 
days 
 
Ongoing 
 Day hospital 
 Hospital / 
University 
Hospital 
 CLCC 
 Private clinic 
 Other: ___ 
 
 AE*. If 
yes, specify 
which one: 
___ 
  
 Other, 
specify: ____ 
 Sutent® dose modification 
 Temporary Sutent® interruption 
 Termination of Sutent® 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending physician 
 Emergency department.  
       Date: ________  
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
         Date: ________ 
         Location: ________ 
  Hygiene and nutrition advice 
 Other, specify: _________ 
 Not applicable 
(Dynamic table: rows can be added if more hospitalisations are observed) 
*: If AE ticked, the physician has already described this AE in the previous section, the e-CRF will thus display the list of AEs 
already filled in and the physician can simply select the relevant AE (without having to describe it again) 
 
3.8 Decision concerning sunitinib treatment 
Participating physician's decision following this follow-up visit 
 
 Continue treatment, date of day 1 of next cycle:  /  /  (DD/MM/YYYY) 
Dose and dosage regimen:  
 50 mg/day, 4 weeks followed by a 2-week break 
 Other, specify: _____________ 
 
 Termination of current treatment, date stopped::  /  /  (DD/MM/YYYY) 
 
 
 
 Break from therapy 
  
 Change of line of therapy (fill in the end of treatment appraisal form) 
 
  Continued break from therapy 
 
 Resumed sunitinib treatment, date resumed:  /  /  (DD/MM/YYYY) 
In the event of treatment termination, the physician is directed to the end of treatment form. 
 

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3.9 Sunitinib treatment accompanying measures if treatment continued  
The patient was given information for his/her Sunitinib® treatment since the last documented visit dated [date of 
last recorded visit] (several boxes possible): 
                 
 no new information 
                                  by yourself   
  by the care team. Specify the type of individuals involved (nurse, intern, etc.) 
__________________________ 
 by means of an information leaflet or any other medium / material / document issued to the 
patient: 
Specify the medium: ____________________ 
                        other:  __________________________________________________________ 
 

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4 END-OF-TREATMENT FORM 
DATA CONCERNING TERMINATION OF THE FIRST LINE OF TREATMENT 
Date treatment stopped  /  /   (DD / MM / YYYY) 
 
Reason for termination of Sutent® 
 Disease progression 
 Toxicity, specify 
 
_______________________________________  
 
has an AE report form been filled in:  Yes No 
 
 
if no, please report the AE   
 Intercurrent disease, specify  
_______________________________ 
 Patient's choice 
 Physician's choice, specify 
 
_______________________________ 
 Death 
has an AE report form been filled in:  Yes No 
 
 
if no, please report the AE 
 Other, give details:  
 
 
____________________________________ 
 
 
DISEASE OUTCOME 
Best response to first line treatment with sunitinib (RECIST criteria) 
 Complete response  
 Stable disease 
 Partial response 
 
 
 Disease progression 
  Not assessable    If NA, Reason:  
 
 
 
 
 
 
 
Date of first progression before initiation of a second metastatic line (if not specified in previous tumour 
evaluation) 
 /  /   (DD / MM / YYYY) 
 
 
 
 
 
 
 
 
 
 

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14.7. Appendix 7: Intervention by nurse 
 
 
RENACALL STUDY 
 
Evaluation of the impact of a therapy 
management platform on the management of 
patients suffering from advanced/metastatic 
renal cell carcinoma and receiving first line 
treatment with sunitinib, versus standard 
follow-up  
 
 
I N T E R V E N T I O N  B Y  N U R S E  
 
 
 
 
 
 
 
 
 
 

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A. MANAGEMENT BY THE THERAPY MANAGEMENT PLATFORM  1 
 
The patients will be monitored not only in the standard manner, but also via the therapy 
management platform.  
Calls shall be made by nurses specially trained for this role, from a centralised platform based 
in the Paris region. If necessary, the nurses may be assisted by physicians from the therapy 
management platform.  
 
The aim of these calls is to support the patients in the management of their treatment by 
listening to and advising them, implementing preventive measure and taking actions when 
deemed necessary; the purpose of these calls is to support patients in the management of their 
sunitinib treatment. 
 
Call frequency is presented in the following figure:  
 
 
Figure 1. Call frequency for patients 
 
 
The chosen rate is of:  
- For the first two cycles, C1 and C2: 5 calls during the first 5 weeks of each cycle (i.e. 
one call per week; no call during week 6 as the patients are usually seen in 
consultation), 
- For cycles 3 and 4: 2 calls per cycle on weeks 2 and 4. 
 
These calls will be made for patients treated with Sutent®; in the event of termination of 
treatment during the follow-up period, the call following termination will close the 
intervention. In the event of cycle start postponement, the first call made shall be postponed to 
match the expected organisation (cycles 1 and 2: first call during week 1 of the cycle; cycles 3 
and 4: first call during week 2 of the cycle). 
 
                                                 
1 Information obtained from the RENACALL protocol 

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B. DATA COLLECTED 
 
 
1st call 
Follow-
up calls 
Freephone 
number 
call 
General information concerning the interview 
X 
 
 
Patient's general condition 
X 
X 
X 
Introduction: treatment initiation 
X 
 
 
Introduction: support follow-up and treatment 
resumption 
 
X 
X 
Treatment compliance (+ Morisky at W4 cycles 1, 2 
and 4) 
X 
X 
X 
Initial and support prescriptions 
X 
 
 
Additional prescriptions 
 
X 
X 
Care pathway (medical procedures, hospitalisation, 
emergencies) 
X 
X 
X 
Examination and additional tests follow-up 
X 
X 
X 
Tolerance, reported side effects 
X 
X 
X 
Monitoring of side effects and corrective actions 
 
X 
X 
Setting appointments 
X 
X 
X 
Overview of advice and preventive actions covered 
X 
X 
X 
Declaration + transmission of report sheets 
X 
X 
X 
 
* During ad hoc calls to the freephone number, the nurse can go directly to the desired 
section of the questionnaire in order to meet the patient's request  

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C. PRE-CALL CHECK-LIST 
Instruction: Check-list pre-filled for the nurse. This sheet can be printed from the CATI 
system at the start of the call.  
The data are obtained from the physician CRF and from previous calls. The information will 
also be displayed during the call in the appropriate sections, where they can be updated.  
[Date - time of sheet generation] 
Patient characteristics 
Name: ___________ First name: ___________   Age: 
________ 
ECOG: _________(date)      Heng criterion: ________(date) 
Call: Week x, Cycle x (Nth scheduled call) 
Physician information 
Name: _____________ 
First name: ___________ 
Tel.: ___________ 
Information received by the patient:  
Verbal information from the oncologist; verbal information from the medical team; written information (specify 
medium) 
Medical history and current co-morbidities 
Diabetes; Hypothyroidism; Hyperthyroidism; Stroke; Hypertension; Deep vein thrombosis; Myocardial 
infarction; Angina pectoris; Kidney failure; Liver failure; Other: ____ 
Concomitant treatments 
Surn
ame 
Indication 
Date first taken 
Status 
Reason for 
prescription 
Dosing 
Recomme
ndations 
---- 
--- 
--- 
--- 
--- 
__  
--- 
  
Adverse events (resolved and unresolved) 
AE 
type 
AE 
descripti
on  
Start 
date 
Severity 
Grade  
Causal 
relationshi
p 
Change 
Corrective 
medical 
action 
Action on 
suspected 
treatment 
Overview of all previous AEs (e-CRF + CATI) and follow-ups 
--- 
--- 
--- 
--- 
--- 
--- 
--- 
--- 
--- 
  
 
History of calls to a healthcare professional (scheduled and unscheduled) 
Date 
Type of call 
Specialist field of the 
healthcare professional 
Reason for the 
call 
Action 
impleme
nted 
__/__/__ 
 
--- 
--- 
--- 
--- 
 
History of consultations with a healthcare professional (scheduled and unscheduled) 
 
Date 
Type of 
consultation 
Specialist field of the 
healthcare professional 
Reason for 
consultation 
Action implemented 
__/__/__ 
--- 
---  
--- 
--- 
 
History of hospitalisations (scheduled and unscheduled) 
Date 
Type of 
hospitalisation 
Duration 
Location 
Reason 
Action 
implemented 
__/__/__ 
 
--- 
--- 
--- 
--- 
--- 
Nurse's comments:  
General CATI comment: ____ 
Name (date): ________ 
Oncologist's response: ______ (where applicable) 

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Name (date): ________ 
Oncologist's response: ______ (where applicable) 
D. INTERVENTION BY NURSE 
Info: Depending on the type of call (1st call, cycle-start call or last call), the nurse will be 
automatically directed to the relevant patient questionnaire. The important data obtained 
from the physician CRF and from previous CATI calls will be made available to the nurse 
throughout the questionnaire and can be updated and completed.  
 
D.1. Phone contact 
1- Hello, I am [Nurse's Last and First names], a nurse with the company 
. I 
am calling in the context of the Sutent® treatment follow-up (therapy management 
platform). Could I speak to [Patient's Last and First names].  
- 
If Yes, I am calling you for your support in taking the Sutent® treatment. Are you 
available to talk about it?  
 If Yes, go to "Start call" 
- 
If not, or not available at this time: go to "Unsuccessful call / appointment" 
 
Setting appointments 
Info: The CATI Appointment module allows periods of unavailability to be specified, 
during which the patient does not wish to be called. The preferred call times are available 
via this module.   
- 
If first call:  
The first interview must be held within 7 days of prescription of your Sutent® 
treatment, that is between [Sutent® prescription date] and [date + 7 days]. Would 
you be available during this period? At what time could we call you?  
 [Make an appointment] 
- 
Subsequent calls: 
In order to respect the call schedule, it was agreed that we would call you between 
[theoretical call date -1 day] and [theoretical call date +1 day]. Would you be 
available during this period? At what time could we call you?  
 [Make an appointment] 
 
D.2. Introduction and general discussion 
D.2.1. General introduction to the first call:  
Info: Information to present to the patient during the first call only 
 
 A few days ago, your oncologist, Dr [Doctor's Last and First names] offered you 
regular telephone support to assist you in the management and tolerance of the 
Sutent® treatment he/she prescribed for you.  I am a member of the team of nurses 
working in collaboration with your physician. (Whenever possible, you will speak with 
me during your future calls). 
 
 I propose to call you on a regular basis to answer any questions you may have, to 
discuss your health and to advise you in the management of your treatment. For this, it 
PPD

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is agreed that i will call you once a week for the first 3 months of treatment, then once 
every two weeks for the following 2 cycles. (In all, 14 calls are scheduled) 
 
 I would also like to point out that the purpose of these calls is not to replace Dr 
[Doctor's Last and First names] for the treatment or diagnosis of your disease. Your 
physician will continue to treat you as normal; We are here to assist you in managing 
your treatment, to advise you, to answer any questions you may have and to help you 
deal with any events that may occur. We are in constant connection with your 
physician, who will receive a report of each phone call and we can contact him/her by 
phone if necessary.  
 
1- If first call: Did your physician clearly explain how to take the treatment? )   
Yes  No 
 If yes or no:  Advice on taking the treatment: Sutent® treatment takes 
place in cycles: it must be taken every day (50mg once per day) for 4 
weeks, followed by a 2-week break without treatment. This treatment 
can be taken either with or without food, with a large glass of water, at 
any time during the date, though preferably at a set time. 
 
2-  If first call: Did your physician or the medical team give you a document 
concerning your treatment, such as an information note or follow-up notebook? 
Have you read it?  Yes    Yes, Sutent® notebook   No 
 If Yes, or Yes Notebook, Do you have any further questions?  
 If Yes notebook! Sutent® notebook advice: In the notebook you were 
given, you can take notes and keep a treatment calendar, along with a 
schedule of appointments with your physicians, or of examinations you 
need to do. You can also enter any adverse events or drug reactions that 
may occur, along with their onset date and duration. This will enable 
the medical and care teams to better help you manage your treatment 
and your health.  
 I would ask you to have your notebook with you during the 
future calls so that you can readily access this information. You 
can also take this notebook with you during your consultations 
with the oncologist, in order to discuss any remarks you may 
have with him/her. 
 If Not, (check the data on the summary sheet)  
 If the patient has received a document: Your physician indicates 
that he/she issued you with [document], do you remember? 
Have you read it? 
 
 
3- If first call: Did your physician explain how you should manage any 
treatment-related side effects that may occur?  Yes  No 
 If yes or no: 
 Over the coming months, please do not hesitate to inform us of any 
problems related to your general condition that you may encounter, 
even the mildest ones, or that do not seem serious. 

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 I would also like to inform you that you can contact us on the study's 
freephone number [freephone number] should you suffer any adverse 
event, or should you require any other advice. You can contact us 
during the week between 9am and 7pm. 
 In case of a serious event, however, or for any other emergency 
situation, you should directly call your oncologist or the emergency 
services (Emergency medical services: 15 or Fire brigade: 18) who can 
respond rapidly and thus provide better assistance.  
 
4- If first call: Let's go over the treatments prescribed by your physician. Has 
your physician prescribed any support medicines?  Yes  No If yes, Do you 
have the prescriptions with you? Do you know what medicines have been 
prescribed for you?  
  If Yes, Do you have the prescriptions with you? Do you know what 
medicines have been prescribed for you?  
 [Check that the patient has the necessary information and that 
he/she is aware that he/she can act on his/her symptoms. Help 
him/her identify the treatments and their symptoms. Advise him/her 
to keep the prescriptions available.]  
 If yes, Do you have these medicines available at home?  
 [Identify the systematic prescriptions to start upon initiation of 
Sutent® treatment, along with the supplemental prescriptions to use 
as and when necessary.] 
 If not, Check the data entered 
 If prescriptions received: Unless we are mistaken, the physician 
informed us that he/she prescribed you [treatments]. Do you have 
this prescription or treatment with you? 
 
Table 2 + Concomitant treatments 
Surn
ame 
Indication 
 
Date first 
taken 
Status 
 
Reason for 
prescription 
 
Dosing 
 
Physician's 
advice 
 
Overview of previous treatments 
Name
: ___ 
 
 
-neutropenic 
 
and local 
anaesthetics 
moisturising 
creams 
 
-gastro-
oesophageal reflux 
agents 
ates 
____ 
taken:  
__ / __ / __ 
(DD/MM/Y
YYY) 
 
necessary 
 
 
 
  End date __ 
/__/__  
(DD/MM/YYY
Y) 
 
 
 
 
 Not 
available 
 Dosage 
regimen:  
__ doses 
__ time(s) per day 
for __  weeks 
 
 Not available 
Recommendati
ons: _____ 
 
 Not 
available 

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Instruction: identifying all treatments available to the patient will allow the nurses to adapt 
the advice and actions to be implemented. The nurses will have received an anonymised copy 
of the patient's prescriptions from the physician 
5- If first call: Could you tell me when you took Sutent® for the first time?  
Taken  Not taken 
 It taken, Date first taken: __/__/____ (DD/MM/YYYY) 
 If not taken, Why haven't you started the Sutent® treatment? 
 I forgot to start  
 I am stressed / anxious at the though of taking it 
 Other, specify: _____________ 
 Do you have any questions, or topics you would like to discuss before 
starting to take your treatment? [Guide and advise the patient. Notify 
the oncologist if major problem] 
 
D.2.2. Introduction of the "Regular" interview (excluding the first call of the first 
cycle) 
Info: The introduction discussion is a 'free' discussion between the nurse and the patient, to 
be held during each call. It concerns the patient's overall health, in order to win his/her trust 
at the start of the interview. These data will not be collected, unless an AE is declared.  
 
 How have you been since our last talk? How is it going?  
 If resuming a cycle, a tumour evaluation should have been conducted 
during week 6 
 Date of last tumour evaluation: __/__/____ (DD/MM/YYYY) 
 Response: RC / RP/ SD / PD/ NE, reason _____ 
 If answer: encourage the patient during the conversation 
 If disease stable: be optimistic for the remainder of the 
treatment 
 Are you sleeping well? 
 Do you have a good appetite? 
 Are you able to maintain an activity?  
 If an AE is reported, the nurse can access the report form directly [D.5 
Collecting new AEs] 
 
D.2.2.1. 
Introduction of the interview if first call of cycles 2, 3 or 4 
 
1- If start of cycle 2, 3 or 4: Unless I am mistaken, you should have started a 
new Sutent® treatment cycle. Have you resumed your treatment?  Yes  No 
 If yes, Date resumed: __/__/____ (DD/MM/YYYY) 
 If No, Why haven't you resumed the Sutent® treatment?  
  I planned to resume on: date __/__/____ (DD/MM/YYYY)  
  I forgot to resume 
  I am stressed / anxious at the though of resuming 
  I suffered an adverse event (see list of AEs for advice) 
  My physician delayed/temporarily interrupted my treatment  

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  Other, specify: _____________ 
 Do you have any questions, or topics you would like to discuss 
before resuming your treatment? (Guide and advise the patient. 
Notify the oncologist if problem) 
 
2-  If start of cycle 2, 3 or 4: Was the dose or dosage regimen (treatment 
schedule) changed by your physician during your last follow-up visit?  Yes 
 No 
 If no, no change, Check the available data 
 If a change is specified on the e-CRF [Table 1]: Your 
physician informed us that he/she changed [dose/regimen] 
for [value], did he mention this to you?  
 If Yes, (corresponds to the table below) 
 Dose changed:  Yes  No 
o If yes, what is the new prescribed dose: _ _ (mg/day) 
 Change of treatment regimen:  Yes  No 
o If Yes, what is the new regimen: __ every __ days for 
__ weeks, then __ weeks' rest. 
 Reason for change(s)?  
 AE, specify: ____ 
 Other, specify: ____ 
 Not available  
 In the event of an additional visit to the oncologist, the e-CRF may not have been 
updated. If a difference arises between physician and patient data, a validation will be 
requested in the call overview sent to the physician. 
  
Table 1 - Sutent® treatment changes 
Date 
modified: 
Change of 
dose 
If yes, new 
dose 
Change of 
dosage 
regimen 
If yes, new 
regimen 
Reason for 
the 
modification 
__/__/____ 
(DD/MM/YYYY) 
Yes 
No 
 25  
 
37.5 
 50 
 
62.5 
 75       
Other:  
 Not 
available 
 Yes 
 No 
 Regimen: 
______________ 
 
 Not available 
 AE; If yes, 
specify which 
one: __ 
 Other, 
specify:   
 
 Not available 
 
3- If start of cycle 2, 3 or 4: Let's go over the treatments prescribed by your 
physician. Did your physician prescribe any support medicines?   Yes  No 
i. If Yes, Do you have the prescriptions with you? Do you know what 
medicines have been prescribed for you?  
1. [Check that the patient has the necessary information and that 
he/she is aware that he/she can act on his/her symptoms. Help 
him/her identify the treatments and their symptoms. Advise 
him/her to keep the prescriptions available.]  

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ii. If yes, Do you have these medicines available at home?  
1. [Identify the systematic prescriptions to start at the beginning of 
the cycle, along with the supplemental prescriptions to use as 
and when necessary.] 
iii. If not, Check the data entered 
1. If prescriptions received: Unless we are mistaken, the physician 
informed us that he/she prescribed you [treatments]. Do you 
have this prescription or treatment with you?   
 
 
 
 
Table 2 + Concomitant treatments 
Surn
ame 
Indication 
 
Date first 
taken 
Status 
 
Reason for 
prescription 
 
Dosing 
 
Physician's 
advice 
 
Overview of previous treatments 
Name
: ___ 
 
 
-neutropenic 
 
and local 
anaesthetics 
moisturising 
creams 
 
-gastro-
oesophageal reflux 
agents 
 
_________ 
taken:  
__ / __ / __ 
(DD/MM/Y
YYY) 
 
necessary 
 
 
 
  End date __ 
/__/__  
(DD/MM/YYY
Y) 
 
 
 
 
 Not 
available 
 Dosage 
regimen:  
__ doses 
__ time(s) per day 
for __  weeks 
 
 Not available 
Recommendati
ons: _____ 
 
 Not 
available 
Instruction: identifying all treatments available to the patient will allow the nurses to adapt 
the advice and actions to be implemented. The nurses will have received an anonymised copy 
of the patient's prescriptions from the physician 
 

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D.2.2.2. 
Introduction to the mid-cycle interviews (excluding the first call of 
the cycles) 
 
4- If mid-cycle call: Let's go over the treatments prescribed by your physician. 
During our last call, you stated that you had a number of support prescriptions 
or treatments for managing adverse events. Have you been prescribed any 
additional treatments since last time?   Yes  No 
i. If Yes, Do you have the prescriptions with you? Do you know what 
medicines have been prescribed for you?  
1. (record all new prescriptions)  
 
Table 2 + Concomitant treatments 
Surn
ame 
Indication 
 
Date first 
taken 
Status 
 
Reason for 
prescription 
 
Dosing 
 
Physician's 
advice 
 
Overview of previous treatments 
Name
: ___ 
 
 
-neutropenic 
 
and local 
anaesthetics 
moisturising 
creams 
 
-gastro-
oesophageal reflux 
agents 
 
_________ 
taken:  
__ / __ / __ 
(DD/MM/Y
YYY) 
 
necessary 
 
 
 
  End date __ 
/__/__  
(DD/MM/YYY
Y) 
 
 
 
 
 Not 
available 
 Dosage 
regimen:  
__ doses 
__ time(s) per day 
for __  weeks 
 
 Not available 
Recommendati
ons: _____ 
 
 Not 
available 
Instruction: identifying all treatments available to the patient will allow the nurses to adapt 
the advice and actions to be implemented. The nurses will have received an anonymised copy 
of the patient's prescriptions from the physician 
 
 
D.2.3. "Freephone" interview 
Instruction: During calls to the freephone number, the nurse can access all of the CATI 
questionnaire in order to meet the patient's request. Once the patient's request has been dealt 
with, either the next interview can be conducted, depending on its theoretical date, or an 
appointment can be made 
 
 
1- What is the reason for your call?  
 Answer, Advice, Action [Provide the appropriate answer to the 
question, by reference to the concerned section of the questionnaire] 
2- Do you have any other questions or problems you would like to discuss? 
 If yes, [Go to q1] 
 If no, [Go to q3] 

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3- We had agreed to call you on [date] to go over your health and treatment 
management in greater detail. Would you like to talk about this now?  
 If yes, [redirection to "Regular" questionnaire] 
 If no, Could we make an appointment for this interview? [Make an 
appointment] 
 
D.3. Compliance and care pathway 
If 1st call The rest of the discussion covers the period from the last appointment with your 
oncologist dated [inclusion date] (Sutent® initiation consultation) to the current date.   
If subsequent calls: The rest of the discussion covers the period from the last call, dated [date 
of last call] to the current date.  
D.3.1. Treatment compliance  
Since our last call, have you taken your treatment every day?  
 Yes  No 
a) If yes, For information, if you forget to take your capsule one day, do not 
attempt to make up for this omission by taking 2 capsules the next day, take 
only the usual dose. 
If W4 calls for Cycles 1, 2 or 4: Morisky treatment compliance questionnaire 
The following questions concern the entire current cycle, hence the past 4 
weeks:  
i. Did you, at any time, forget to take your treatment?  Yes  No 
ii. Did you sometimes have trouble remembering to take your treatment? 
 Yes  No 
iii. Did you ever stop taking your treatment when feeling better?  Yes  
No 
iv. If you felt worse when taking your treatment, did you at any time stop 
taking it?  Yes  No 
v. When you suffered an adverse event, did you ever reduce or adapt the 
treatment?   Yes  No 
 If at least 1 Yes: Have you forgotten or interrupted your treatment 
since our last call?  
b) If No, could you describe to me the periods when you did not take your 
treatment? What was the reason?  [Report the interruption - Table 3] 
 If omission: For information, if you forget to take your capsule one day, 
do not attempt to make up for this omission by taking 2 capsules the 
next day, take only the usual dose.  
 If W4 calls for Cycles 1, 2 or 4: Morisky treatment compliance 
questionnaire.  
The following questions concern the entire current cycle, hence the past 4 
weeks: [qualify the question if the patient declared having forgotten or 
interrupted his/her treatment: "We have already discussed this, but I 
need to validate certain details"] 
i. Did you, at any time, forget to take your treatment? Yes  No 
ii. Did you sometimes have trouble remembering to take your 
treatment? Yes  No 
iii. Did you ever stop taking your treatment when feeling better?  Yes  
No 

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iv. If you felt worse when taking your treatment, did you at any time stop 
taking it?  Yes  No 
v. When you suffered an adverse event, did you ever reduce or adapt the 
treatment?   Yes  No 
 
Table 3 - Treatment interruptions 
Date 
Duration (days) 
Reason for interruption 
Overview of previous interruptions 
_ _ 
- 
__/__/____ (DD/MM/YYYY) 
_ _ 
Ongoing 
Adverse event 
Medical decision 
Omission 
Lack of efficacy 
Improved health 
Other: ________ 
Instruction: if Adverse event is ticked, the AE declaration table appears for data input. New 
AEs are added to the table in section D.5. AE collection 
D.3.2. Scheduled and unscheduled medical procedures 
 Have you called upon or consulted a healthcare professional since our previous 
interview (or since the start of treatment for the first call)?  Yes  No 
 If new call, [Report a new call – Table 4] 
 If new consultation, [Report a new consultation – Table 4'] 
 
 If cycle-end call (week 4): Are you scheduled to see your oncologist during the 
coming weeks?  Yes  No 
 If yes, [Report a new consultation] 
 Reminder: Before the consultation with your oncologist, do not forget to 
perform all the additional tests he/she asked for, to help him/her define the 
most appropriate treatment. If you have a follow-up notebook in which you 
take notes, remember to bring it with you.  
Table 4 - History of calls to a healthcare professional 
Date 
Type of call 
Specialist field of the 
healthcare 
professional 
Reason for the 
call 
Action implemented 
Overview of previous calls 
 /  / 
 
(DD/MM/YYYY) 
 Scheduled  
 Unscheduled 
List {General 
practitioner; 
Oncologist; 
Cardiologist; 
Nephrologist; 
Accident and 
Emergency; 
Nurse;  
Other, etc.} 
 
If Other, specify: 
_____ 
 AE; specify: 
___ 
 
  
 Other 
 Temporary Sutent® interruption 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical 
specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending 
physician 
 Emergency department.  
       Date: __/__/____ 
(DD/MM/YYYY) 
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
       Date: __/__/____ 
(DD/MM/YYYY) 

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       Location: ________ 
 Hygiene and nutrition advice 
 Other, specify: _________ 
 Not applicable 
 
Instruction: if Adverse event is ticked, the AE declaration table appears for data input. New 
AEs are added to the table in section D.5. AE collection 
Table 4' - History of consultations with a healthcare professional 
Date 
Type of 
consultation 
Specialist field of the 
healthcare 
professional 
Reason for 
consultation 
Action implemented 
Overview of previous consultations 
 /  / 
 
(DD/MM/YYYY) 
 Scheduled  
 Unscheduled 
List {General 
practitioner; 
Oncologist; 
Cardiologist; 
Nephrologist; 
Accident and 
Emergency; 
Nurse; 
Other, etc.} 
 
If Other, specify: 
_____ 
 AE; If yes, 
specify which 
one: ___  
 Scheduled 
examination  
 Other 
 Sutent® dose modification 
 Temporary Sutent® interruption 
 Termination of Sutent® 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending physician 
 Emergency department.  
      Date: __/__/____ (DD/MM/YYYY) 
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
      Date: __/__/____ (DD/MM/YYYY) 
       Location: ________ 
 Hygiene and nutrition advice 
 Other, specify: _________ 
 Not applicable 
 
Instruction: if Adverse event is ticked, the AE declaration table appears for data input. New 
AEs are added to the table in section D.5. AE collection 
 
 
D.3.3. Hospitalisations or visits to accident and emergency  
 Have you been hospitalised, or have you been to accident and emergency since our 
previous interview (or since the start of treatment for the first call)?  Yes  No 
 If Yes, [Report a new hospitalisation – Table 5] 
 If Yes, Did the hospitalisation lead to a temporary interruption of treatment??  
Yes  No 
 If Yes, have we discussed this previously?  Yes  No 
 If No, [Report a new treatment interruption – Table 3] 
 
 
 
 
 
 
 

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Table 5 - Hospitalisations or visits to accident and emergency 
Date 
Type of 
hospitalisation 
Duration (days) 
Location 
Reason 
Action implemented 
Overview of previous hospitalisations 
__/__/___ 
(DD/MM/Y
YYY) 
 Scheduled 
 Unscheduled 
_ _ day 
 
 Not available 
 Day hospital 
 Hospital / 
University 
Hospital 
 CLCC 
 Private clinic 
 Other: ______ 
 
 Hospital (no 
details) 
Adverse 
event 
Other: 
____ 
 Sutent® dose modification 
 Temporary Sutent® interruption 
 Termination of Sutent® 
 Treatment prescribed 
           Specify: ______ 
 Consultation with medical 
specialist 
            Nephrologist        
            Cardiologist 
            Other: ______ 
 Consultation with attending 
physician 
 Emergency department.  
      Date: __/__/____ 
(DD/MM/YYYY) 
       Location: ________  
       Hospitalisation: Yes No 
 Hospitalisation. 
      Date: __/__/____ 
(DD/MM/YYYY) 
       Location: ________ 
 Other, specify: _________ 
 Hygiene and nutrition advice 
 Not applicable 
Instruction: if Adverse event is ticked, the AE declaration table appears for data input. New 
AEs are added to the table in section D.5. AE collection 
D.3.4. Monitoring additional examinations 
 If cycle-start call for cycle 1, 2, 3 or 4 (post oncologist visit) 
Did your oncologist ask you to perform additional examinations over the coming 
weeks of treatment?  Yes  No 
 If Yes, What examinations did he/she recommend carrying out? When do you 
need to do them? [Add an examination – Table 6] 
 If you have these examinations before the next call, do not hesitate to 
have your results with you so we can discuss them.  
 Amongst these examinations, have you already had any? Which ones?  
o If Yes, Are there any points you would like to talk about?  [AE report 
depending on results] 
 If mid-cycle call: 
 During our previous calls, you stated having one or more additional examinations. Did 
you do them?  Yes  No 
 If Yes, When did you have it? [update Table 6] 
o If Yes, Are there any points you would like to talk about?  [AE report 
depending on results] 
 If No, The examination results that you notify to the medical team in charge of 
following you may, if your physician deems necessary, lead to an adaptation of 
your treatment. It is thus important that you undergo the examinations 
requested by your physician in order to help him/her care for you.  
 

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Table 6 - Additional examinations 
Type of examination 
Recommended date Status  
Result 
Biological examination, blood 
sample 
Urine analysis 
Hypertension monitoring 
Cardiovascular profile 
Thyroid function profile 
Liver profile 
Oral profile 
Skin clinical examination 
Other: …. 
Date: __/__/____ 
(DD/MM/YYYY) 
Frequency: __/wk 
 
 Not applicable 
Done, date: __/__/____ 
(DD/MM/YYYY) 
Appointment made, Date: 
__/__/____ 
(DD/MM/YYYY) 
To do 
Don't know 
Normal 
Abnormal: AE 
D.4. Tolerance and actions implemented 
Monitoring of the outcome of previously reported adverse events 
 During the last call of [date], we spoke of your problems concerning [event]. 
 What is the current situation? [Update Table 7] 
 We had determined that you could do [action] to prevent / relieve [event]. Did 
you do it? Did it provide relief? [Update Table 7] 
 
 Adverse event follow-up 
 If the AE is resolved and where applicable, inform the patient of 
actions to implement to prevent the recurrence of symptoms 
 
In the event of AE progression, new estimation of grade and of medical 
actions to implement [see section D.5. New AE collection]  
Table 7 - Adverse events (past and current) 
Type of 
event 
Descrip
tion of 
the 
event 
Start 
date 
Severity 
Grade 
(CTCAE 
v4.03) 
Impact 
on 
activities 
of daily 
living 
Causal 
relation
ship 
Change 
Corrective 
medical action 
Action on 
suspected 
treatment 
Overview of all previous AEs (e-CRF + CATI) and follow-ups 
 
(list 
choice) 
……
…….. 
……
…….. 
……
…….. 
--/--/-- 
(DD/M
M/YYY
Y) 
 Non-serious 
 Serious 
If serious, severity 
criteria (several possible 
answers): 
 Caused death 
If death, specify:  
Date of death: --/--/---- 
(DD/MM/YYYY) 
Cause of death: ___ 
 Life-threatening 
 Hospitalization / 
prolonged 
hospitalization 
 Permanent or major 
invalidity or disability 
 Anomaly / congenital 
malformation 
 Medically significant 
event 
 Grade 0    
 Grade 1    
 Grade 2    
 Grade 3    
 Grade 4 
 
  Does not 
affect daily 
life 
 Makes 
certain 
actions 
difficult to 
accomplish 
 Affect 
activities of 
daily life 
 
Related 
to taking 
Sutent
® 
 
Related 
to a 
concomi
tant 
medicin
e; 
Specify 
the 
treatmen
t: __ 
 Recovered  
If recovered, 
recovery date: --
/--/--
(DD/MM/YYY
Y) 
 
 Recovered 
with sequelae 
If recovered, 
recovery date: --
/--/--
(DD/MM/YYY
Y) 
 
 Recovering 
 Not recovered 
 Unknown 
 Prescription 
of a treatment, 
specify:  
 Medical 
consultation 
(general 
practitioner, 
specialist, 
emergency 
department) 
 
Hospitalisation.  
 Nurse's 
advice, specify: 
_____ 
 Other, 
specify:  
 Not 
 Interruption 
(temporary, 
permanent, or 
delayed) 
 Dose 
reduction 
 
Dose 
increase 
 Dose 
unchanged 
 Unknown 
  Not 
applicable 

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applicable 
Instruction: for all current AEs, check AE outcome. If the AE is unresolved, a new row will be 
generated and linked to the source row. AEs reported by the physicians via the e-CRF are 
distinguished from AEs reported by the nurses using CATI.  
D.5. New AE collection  
Intro: as the interview progresses the nurse will gain access to the various screens 
concerning the adverse events described by the patient at any time during the telephone 
conversation; moreover, at this stage of the interview, the nurse will check for any other AEs 
that may not have been mentioned before.   
 
Since the last interview, since starting taking Sutent® (for the first call), have you had any 
discomfort, or have you experienced unexpected effects related to your Sutent® treatment 
other than those we have already discussed?  Yes  No  
 If Yes, [Go to AE information collection questionnaire] 
 Once the patient has finished describing the AE: Have you experienced any 
other discomfort or adverse reactions?  
 If not, check for the absence of AEs: Do not hesitate to report any problems you might 
encounter, even the mildest such as for example:  
 Changes to skin, nail or hair 
 Digestive disorders 
 Breathing difficulties 
 Heart disorders or change in blood pressure  
  Mouth or gum problems 
 Other adverse events such as tiredness or fever, etc. 
 
 
Ongoing grade 3 / 4 AE: Recommendation for temporary interruption of Sutent® treatment 
pending oncologist's medical opinion:    Yes 
 No 

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 If Yes, In this situation, I recommend that you temporarily interrupt your Sutent® 
treatment until further notice. Your oncologist will be alerted and his/her medical 
opinion requested. We will contact you to inform you of his/her decision.  
 
 
 
Activities of daily life: preparing meals, shopping, using a telephone, paying.  
Major daily activity: Showering, dressing and undressing, eating, going to the toilet.  
 
Instruction: any report of a grade 3 or 4 AE, except for a biological AE, will trigger an email 
alert for the oncologist + Level 3 TEC. Other alerts are generated on a case by case basis for 
certain grade 2 AEs. 

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Table 8 - AE / Grade / Action look-up table for Sutent®-related AEs 
Adverse event 
CTCAE grade estimation 
Recommendations and Actions to implement 
Skin toxicity 
- 
Skin irritation 
- 
 Dry skin 
- 
Cracked skin 
- 
Nail fissures  
- 
Hyperkeratosis (corn, 
psoriasis, warts) 
- 
Intensity of dryness?  
o Asymptomatic <10% of body area and not 
associated with erythema or pruritus (Grade 
1) 
o Symptomatic 10 to 30 % of body area and 
associated with erythema or pruritus (Grade 
2) 
o >30% of body area and associated with 
erythema or pruritus (Grade 3) 
- 
Impact on daily life  
o Does not affect activities of daily life 
(Grade 1 / 2) 
o Affects activities of daily life (Grade 2 > 
Grade ) 
 
- 
No event / prevention: moisturising cream to 
prevent dryness, Dexeryl or Biafine emollient 
cream, pedicure and manicure at start of 
treatment 
- 
Grade 1: antiseptic foot bath, bepanthren / 
moisturising cream for relief, salicylic acid 
officinal formula (apply a thick layer of cream 
after evening ablutions, then put on socks).  Use 
gentle and scent-free soap. 
- 
Grades 2 and 3: consultation with dermatologist 
or chiropodist (rapid care required as difficult to 
estimate / manage over the phone) 
- 
Hand and foot 
syndrome 
- 
Minor skin 
o Alterations or dermatitis (Grade 1) 
o Desquamation, blisters, haemorrhagic 
lesions, oedema (Grade 2) 
o Ulcerative lesions (Grade 3) 
- 
Sensitivity / pain / discomfort 
o Painless (Grade 1) 
o Pain with no functional impairment (Grade 
2) 
o Functional impairment with no pain (Grade 
2) 
- 
Grade 1: urea-based daily use keratolytic emollients, 
e.g.: Xerial® 30 or 50 (labo SVR), Akerat S® (Avène). 
- 
Grade 2: consultation with oncologist or GP if 
involved in patient follow-up and good 
relationship with patient + alert oncologist in 
report. 
- 
Grade 3: patient's condition requires consultation 
with oncologist  

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o Pain and functional impairment (Grade 3) 
- 
Skin colouration 
- 
Dermal alteration 
 
- 
Intensity of discolouration 
o Mild: < 10% of body area   No 
psychological impact. (Grade 1) 
o Pronounced: >10% of body area + 
psychological impact (Grade 2) 
- 
Dermal alteration 
o Mild thickening (Grade 1) 
o Leathery appearance; papillary formation 
(Grade 2) 
- 
No event / prevention to grade 2: temporary non-
contagious alteration, without consequences. No 
direct care required. 
- 
Alopecia 
- 
Intensity of hair loss  
o Thinning or localised <50%, wig not 
needed. (Grade 1) 
o Total (Grade 2) 
- 
Grades 1 and 2: no treatment or action to 
implement, but reversible in most cases 
Digestive disorders 
- 
Acid reflux 
- 
Heartburn 
- 
Description of intensity 
o Mild (Grade 1) 
o Moderate or mild, but frequent (Grade 2) 
o Severe or moderate, but frequent (Grade 3) 
- 
Grade 1: Gaviscon for initial reflux episodes. 
Avoid food causing reflux 
- 
Grade 2: continue Gaviscon + Inexium (IPP) as 
self-medication if reflux too frequent 
- 
Grade 3: contact oncologist 
- 
Diarrhoea 
- 
stool frequency 
o stools more frequent, but < 4/day compared 
to usual, not necessarily liquid (grade 1) 
o very frequent stools < 4-6/day, liquid (grade 
2) 
o >7 stools/day, incontinence, impact on 
activities of daily living. 
- 
Accompanied by vomiting?  
o Yes (Grade 3) 
- 
Grade 1: Dietary advice (drink often and in small 
amounts; low-fibre diet) + take antidiarrhoeal 
agents prescribed by physician: smecta, the 
imodium, then tiofan according to intensity 
(reassess the grade) 
- 
Grade 2: if treatments no longer sufficient, 
contact attending physician.  
- 
Grade 3: vomiting + diarrhoea: consult GP 
rapidly as need to be examined 
- 
Nausea 
- 
Vomiting 
- 
Nausea:  
o loss of appetite with no change in eating 
- 
Grade 1: antinauseant / preventive anti-emetic; 
nutritional advice (eat slowly, fractionate meals, 

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habits (Grade 1) 
o Reduction in food intake, without 
significant weight loss, dehydration or 
malnutrition. (Grade 2) 
o Reduced calorie intake or tube feeding 
(Grade 3) 
Vomiting:  
- 
 Frequency / 24 hours 
o 1 to 2 episodes (at least 5 min. apart).   
(Grade 1) 
o 3 to 5 episodes (at least 5 min. apart) (Grade 
2) 
o >6 episodes, reduced calorie intake or tube 
feeding  
- 
Other factors?  
o Persistence over 48h or combined with 
diarrhoea (Grade 1 → 2, 2 → 3) 
avoid fatty or spicy meals, drink between meals)  
- 
Grade 2, 3: persistent or vomiting + diarrhoea: 
consult GP rapidly as need to be examined 
 
- 
Abdominal pain 
- 
Pain level  
o Mild (Grade 1) 
o Moderate + impact on activities of daily 
living.  (Grade 2) Severe ++ major impact 
on activities of daily living (Grade 3) 
- 
Blood in stools (Grade 2 > 3) 
- 
Grade 2: alert oncologist in report 
- 
Grade 3: contact oncologist by phone + alert 
oncologist by email 
Heart disorders 
- 
Hypertension 
- 
Have you measured your blood pressure, or had it 
measured recently?  
o 120-139  / 80-89  (Grade 1) 
o 140-159 / 90-99  (Grade 2) 
o ≥ 160 / ≥100 (Grade 3) 
o Malignant HTN, transient or permanent 
neurological deficit (Grade 4) 
- 
Grade 1: Continue regular monitoring and taking 
treatment if prescribed. Contact oncologist 
preventively as nurse does not have all necessary 
information to determine severity 
- 
Grades 2 and 3: Contact oncologist rapidly, 
he/she will decide whether treatment should be 
initiated  

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- 
Other concomitant symptoms?  
o Dizziness, tiredness (Grade 1 > Grade 2) 
o Pre-existing heart disease, kidney failure, 
single kidney (Grade 1> Grade 2, Grade 2 > 
Grade 3) 
Haemorrhagic and endocrine disorders 
- 
Anaemia 
- 
STANDARD Man: 13 – 17 g/dL; Woman: 12 – 15 
g/dL 
- 
Grade 1: < 10 g/dL (6.2 mmol/L or 100g/L) 
- 
Grade 2: 8 – 10 g/dL (6.2- 4.9 mmol/l or 100-
80g/L) 
- 
Grade 3: <8 g/dL (≤ 4.9 mmol/L or 80 g/L) 
- 
Grade 1: no action 
- 
Grade 2: oncologist email alert 
- 
Grade 3: patient contacts oncologist 
- 
Haematuria 
 
- 
Alert oncologist by email as soon as haematuria 
observed 
- 
Neutropenia 
- 
Grade 0: 1,8 – 7 *109/L  
- 
Grade 1: 1,5 – 1.8 *109/L 
- 
Grade 2: 1,0 – 1.5 *109/L 
- 
Grade 3: 0.5 – 1.0 *109/L  ( 1000 mm3 + fever) 
- 
Grade 4: <0,5 *109/L 
 
Presence of fever?  
Yes (Grade 2 > 3, 3 > 4) 
- 
Grade 1: no prescription of GCSF, talk to 
oncologist at next visit 
- 
Grade 2: alert oncologist in report 
- 
Grade 3: alert oncologist by email; if fever: 
Fever management advice + rapidly contact 
oncologist by phone 
- 
Grade 4: rapidly contact oncologist by phone 
- 
Thrombocytopaenia 
- 
STANDARD   > 150 * 109/L 
- 
Grade 1: 75,0 – 150 *109/L 
- 
Grade 2: 50,0 – 75.0 *109/L 
- 
Grade 3: 25,0 – 50.0 *109/L 
- 
Grade 1: no action recommended 
- 
Grade 2: oncologist email alert 
- 
Grade 3: rapidly contact oncologist + alert 
oncologist by email 
- 
Increased 
creatininaemia 
- 
STANDARD:  7 to 13 mg/L  
- 
Grade 1: 1 to 1.5* previous value 
- 
Grade 2: 1.5 to 3* previous value 
- 
Grade 3: 3 to 6* previous value 
- 
Grade 4: >10 * previous value 
- 
No grade 1 event, recommend drinking to avoid 
dehydration. Creatinine drops during the 2 weeks 
of break.  
- 
Grade 2: oncologist email alert 
- 
Grade 3: rapidly contact oncologist + alert 

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- 
 
oncologist by email 
- 
Hypothyroidism 
- 
Grade 1: TSH 5 to 10 μU/mL 
- 
Grade 2: TSG > 10 μU/mL 
- 
Grade 1: asymptomatic, does not require 
management 
- 
Grade 2: general practitioner, additional tests to 
implement appropriate treatment 
- 
Hyperthyroidism 
- 
Grade 1: TSH 0.30 to 0.10 μU/mL 
- 
Grade 2: TSH < 0.10 μU/mL 
 
- 
Grade 1: asymptomatic, does not require 
management 
- 
Grade 2: general practitioner, additional tests to 
implement appropriate treatment 
Infectious problems 
- 
Mucositis 
- 
Stomatitis 
- 
Ulcers 
- 
Infections of the oral 
mucosa 
- 
Intensity and location  
o Asymptomatic (Grade 1) 
o Localised ulceration, swallowing 
difficulties, dry mouth (Grade 2) 
o Confluent ulcers, mild bleeding (Grade 3) 
o Tissue necrosis, significant spontaneous 
bleeding (Grade 4) 
- 
Diffuse pain? (Grade 2) 
- 
No grade 2 event: systematic treatment by 
sodium bicarbonate mouth wash + Kéal; oral 
hygiene advice (regular tooth brushing with a 
soft toothbrush) 
o If ulcers present, fungal treatment and/or 
viscous xylocaine treatment 
o If pain, Efferalgan® codeine mouthwash 
- 
Grade 3: Contact oncologist / emergency 
department rapidly 
- 
Grade 4: Emergency department / hospitalisation 
- 
Gingivitis 
 
- 
How intense is the pain?  
o Mild (Grade 1) 
o Moderate (Grade 2): 
o Severe (Grade 3) 
- 
Do you experience discomfort when eating meals?  
o Mild (Grade 1) 
o  Strong discomfort with oral meals (Grade 
2) 
o Oral feeding impossible (Grade 3) 
- 
Diffuse pain? (Grade 2) 
- 
Grade 1: treatment with pansoral, talk to 
oncologist at next visit 
- 
Grade 2: efferalgan codeine mouthwash for pain. 
Talk to oncologist at next visit. Alert oncologist 
by email.    
- 
Grade 3: Alert oncologist by email + call 
oncologist 
- 
Diffuse oral pain 
o - Moderate pain (Grade 1)  
- 
Grade 1: treatment with pansoral, talk to 

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o - Moderate and limits activities of daily 
living (Grade 2) 
o - Severe + Major daily impact  
oncologist at next visit 
- 
Grade 2: efferalgan codeine mouthwash for pain. 
Talk to oncologist at next visit. Alert oncologist 
by email.    
- 
Grade 3: Alert oncologist by email + call 
oncologist 
- 
Fever  
- 
Ignition  
o 38-39 °C (Grade 1) 
o 39-10 °C (Grade 2)  
o > 40 °C for less than 24 hours (Grade 3) 
o > 40 °C for more than 24 hours (Grade 4) 
- 
Other symptoms?  
o Burning sensation when urinating, cough, 
diarrhoea, chills, sweats (Grade 1 > 2, 
Grade 2 > 3) 
- 
No event / prevention: antibiotics not 
systematically prescribed.  
- 
Grade 1: monitor. Paracetamol if <38.2 °C 
without symptoms / If persistent, change to grade 
2 
- 
Grade 2: if 38.2 °C or more after 1h, direct to 
physician, sign of infection. Alert oncologist by 
email.  
- 
Grade 3: If ~40 °C + sign of an infection, direct 
to oncologist + alert oncologist by email. 
- 
Grade 4: emergency department 
Other symptoms 
- 
Headaches 
 
- 
What is the intensity of your headaches?  
o Mild (Grade 1) 
o Moderate (Grade 2): 
o Severe (Grade 3) 
- 
Do your headaches impact the activities of your 
daily life?  
o Does not affect daily life (Grade 1) 
o Makes certain actions difficult to 
accomplish (Grade 2) 
o Affect activities of daily living (Grade 3) 
- 
Presence of dizziness? tinnitus? hypertension or 
risk of hypertension?  (Grade 3) 
- 
Grade 1: treatment with paracetamol 
(Efferalgan®, Doliprane®) or aspirin 
(Aspegic®). Reassure the patient as there is no 
problem of drug interaction.  
- 
Grade 2: redirect to general practitioner. Notify 
during next oncologist visit, particularly if 
several episodes.  
- 
Grade 3: contact oncologist + alert oncologist by 
email. 
- 
Tiredness (asthenia, 
- 
What is the intensity of your tiredness?  
- 
Grades 1 and 2: try to maintain a healthy lifestyle 

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apathy, malaise) 
o Mild (Grade 1) 
o Moderate (Grade 2): 
o Severe (Grade 3) 
o Totally incapacitating (Grade 4) 
- 
Does your tiredness impact the activities of your 
daily life?  
o Does not affect daily life (Grade 1) 
o Makes certain actions difficult to 
accomplish (Grade 2) 
o Affects major daily activities (Grade 3) 
(eat and drink correctly); take as many naps as 
necessary; exercise a little and relax as much as 
possible.  
Stop work during cycle 1 to manage cumulative 
fatigue over the treatment period  
- 
Grade 3: if persistent tiredness / rapid onset, alert 
oncologist by email.  
- 
Weight loss 
- 
Intensity of weight loss 
o 5 to 10% of starting weight (Grade 1) 
o 10 to 20% of starting weight (Grade 2) 
o > 20% of starting weight (Grade 3) 
- 
Grade 1: no care required. Eliminate mucositis, 
heartburn, dysgeusia.  
- 
Grade 2: Implementation of nutritional support 
by general practitioner. Eliminate mucositis, 
heartburn, dysgeusia. 
- 
Grade 3: Inform oncologist rapidly, requires total 
secondary nutrition.  
- 
Other 
cf: CTCAE classification to estimate grade and to determine actions to implement 
 
 

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D.6. Overview of advice and preventive actions to implement 
Instructions: This section is an overview of the advice and preventive actions 
recommendations that the nurse declares to have given the patient throughout the 
questionnaire. The purpose of this summary is to underline the actions to implement 
before ending the call.  
 
Overview of advice given during the interview:  
Before finishing, I would like to go over the important points that we spoke of today: 
[tick the information issued to the patient and perform a brief recap] 
 
Treatment management advice 
 Advice on taking Sutent® (once daily at set times, without opening the capsule. In the event 
of omission, do not double intake. Observe the physician's decisions in the event of interruption 
or termination. etc.) 
 Advice on using the Sutent® follow-up notebook (treatment calendar, appointment 
management, adverse event follow-up, etc.) 
 Report all adverse events (onset, change or increase, etc.) 
General preventive advice:  
 
Advice 
on 
taking 
systematic 
preventive 
treatments 
(identification of preventive treatments to initiate rapidly) 
 Healthy lifestyle advice (healthy eating and drinking, maintaining appropriate physical 
activity, sleeping and relaxing when necessary, etc.) 
 Dietary advice (grapefruit prohibited, healthy and varied diet, etc.) 
 Oral hygiene advice (regular mouthwashes, very gently toothbrush, avoid mint-flavoured 
toothpaste, etc.) 
AE-specific preventive advice: 
 Prevention of skin toxicity (gentle, fragrance-free soap, hypoallergenic moisturising cream 
and products, consultation with a chiropodist at the start of treatment, etc.) 
 Prevention of digestive disorders (drink sufficiently in small amounts; low-fibre diet; avoid 
coffee, alcohol, greasy, spicy or acidic food, etc.) 
 Prevention of cardiac disorders (frequent blood pressure measurements, limit salt and 
alcohol intake, etc.) 
 Prevention of infectious/inflammatory problems (avoid high-risk contacts, regular hand 
disinfection, etc.) 
 Other preventive advice (fatigue management, pain management, regular appropriate 
activity, etc.)  
Actions recommended to the patient:  
 Do not forget the scheduled consultation with the oncologist  
 Perform the requested additional examinations (blood pressure monitoring, blood profile, 
additional examinations requested by the oncologist, etc.)

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E. END OF INTERVIEW AND NEW APPOINTMENT 
 
 I would like to thank you for your time and answers.  
 As agreed, I would like to propose contacting you again between [theoretical date -1 
day] and [theoretical date + 1 day] to go over the management of your treatment and 
any adverse events. Would you like to make an appointment now?  
 Yes: agree on an appointment between [theoretical date -1 day] and 
[theoretical date + 1 day] 
 No: check the preferred call times 
 Note any unavailable periods 
 Have a nice day.  
 
F. PHARMACOVIGILANCE DECLARATION 
Instruction: After finishing the call with the patient, the nurse will be directed to the CATI 
tool Report section in order to issue any reports of adverse events (new AE or AE follow-up) 
identified during the call. A new sheet is generated for each AE. 
At the end of the call, the sheets are sent to Pfizer's PV department and to the physician via 
the e-CRF for validation.  
 
G. SUMMARY OF THE INTERVENTION AND ORGANISATION OF PHONE 
CALLS 
Instruction: A summary note will be generated automatically and sent to the physician via 
the e-CRF. It shall comprise: 
- 
A box with the salient points to be taken into consideration by the physician  
- 
The phone call details (automatic: number of attempts, date and duration of the call) 
- 
A summary of events declared by the patient (new or follow-up) 
- 
Actions undertaken by the patient and actions recommended to the patient.  
- 
Main advice given to the patient  
 
Validation of any discrepancies between patient and e-CRF data will be requested.  
 
 
 

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14.8. Appendix 8: Adverse event report form 
 
Non-interventional study: 
Adverse event report form  
For Pfizer use 
AER number 
 
Date reported to Pfizer 
 
Enter all dates in DD/MM/YYYY format 
A 
6 
1 
8 
1 
2 
1 
3 
 
0 
0 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL / STUDY NUMBER 
 CENTRE NO.          
PATIENT ID/RANDOMISATION NUMBER 
Protocol title: RENACALL STUDY: Evaluation of the impact of a therapy management platform on the management of patients 
suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sunitinib, versus standard follow-up 
 Initial report
 Follow-up report 
 
Country in which the event occurred:  
Patient data 
Age: _________ 
Height:_________ cm 
Ethnic origin: 
 Man 
 Woman 
Weight: _________ 
kg 
  Local regulations forbid asking the question 
If the patient is 
deceased: 
Date of death: ___/_____/______ 
Cause of death: 
____________________ 
Autopsy performed 
 YES 
 NO 
 UNKNOWN 
If yes, what is the cause of death as determined by 
the autopsy: ___/_____/______   
Patient's history 
□
  None□
 
Unknown 
Note any relevant medical history below. Include any other diseases present at the time of the event, along with pre-existing 
medical conditions. If there is not enough space, use additional copies of the page.. 
Disease (specify) 
Onset date 
End date 
Tick if disease 
is current 
Relevant information including surgical 
procedures and dates 
 
___/____/______ 
___/____/______ 
 
 
 
___/____/______ 
___/____/______ 
 
 
Test drug, 
Dosage form, 
route of 
administration 
Tick if 
Pfizer 
product 
Assay 
Units 
Frequency 
Start date 
End date 
Tick if 
current drug 
 
 
 
 
 
___/____/______ 
___/____/______ 
 
 
 
 
 
 
___/____/______ 
___/____/______ 
 
Concomitant drugs 
 
None 
Unknown 
Report below any concomitant medicines taken during the 2 weeks preceding onset of the event. Exclude any medicines taken only more than 2 weeks 
prior to onset of the event, along with any medicines taken to treat the event, or taken after onset of the event. If you do not have enough space, use 
several copies of this page. 
Drug name  
(registered trademark and 
INN) 
Indication 
Route of 
administration 
Start date 
End date 
Tick if 
current drug 
 
 
 
___/____/______ 
___/____/______ 
 
 
 
 
___/____/______ 
___/____/______ 
 
Relevant additional 
examinations 
Note only those additional examination results that are relevant to the event(s); for example, laboratory analysis and imaging result. If you do 
not have enough space, use several copies of this page. 
Examination 
Date 
Result 
Units 
Normal values 
Comments 
Lower 
limit 
Upper 
limit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-interventional study: Adverse event report form  
For Pfizer use 

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AER number 
      
Enter all dates in DD/MM/YYYY format 
A 
6 
1 
8 
1 
2 
1 
3 
 
0 
0 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL / STUDY NUMBER 
 CENTRE NO.          
PATIENT ID/RANDOMISATION NUMBER 
SERIOUS ADVERSE EVENTS (if more than 2, use additional copies of this page) 
If known, specify the diagnosis rather than the signs and symptoms. 
Adverse event: __________________________________ 
 
Adverse event: ________________________________ 
 
Onset date: ___/____/______ 
 
Onset date: ___/____/______ 
 
Is the event serious? : 
 YES 
 NO 
Is the event serious? : 
 YES 
 NO 
If yes, specify the seriousness criteria below:  
If yes, specify the seriousness criteria below:  
Seriousness criterion (several choices possible): 
 Caused death 
 Life-threatening 
 Hospitalisation/extension of hospitalisation 
 Permanent or major invalidity or disability 
 Anomaly / congenital malformation 
 Medically significant event 
Seriousness criterion (several choices possible): 
 Caused death 
 Life-threatening 
 Hospitalisation/extension of hospitalisation 
 Permanent or major invalidity or disability 
 Anomaly / congenital malformation 
 Medically significant event 
Progress at the time of this report, or at the time of death: 
Progress at the time of this report, or at the time of death: 
 Recovered 
 Recovery date: ___/____/______    
 Recovered with sequelae 
 Recovering 
 Not recovered 
 Unknown 
 Recovered 
Recovery date: ___/____/______         
 Recovered with sequelae 
 Recovering 
 Not recovered 
 Unknown 
Is there a reasonable possibility that the event was linked to the test 
drug:      
 YES 
 NO 
Is there a reasonable possibility that the event was linked to the test 
drug:      
 YES 
 NO 
 
If yes, specify the test drug: 
____________________________________________           
 
 
If yes, specify the test drug: 
_______________________________________________              
 
Is there a reasonable possibility that the event was linked to a 
concomitant drug:      
 YES 
 NO 
If yes, specify the concomitant drug: _________________        
Is there a reasonable possibility that the event was linked to a 
concomitant drug:      
 YES 
 NO 
If yes, specify the concomitant drug: ________________ 
Last action undertaken during the event(s), specify the name of the 
drug: 
Last action undertaken during the event(s), specify the name of the 
drug: 
__________________________ 
__________________________ 
__________________________  
__________________________  
 Interruption (temporary, 
permanent, or delayed) 
 Dose reduction 
 Dose increase 
 Dose unchanged 
 Unknown 
 Not applicable 
 Interruption (temporary, 
permanent, or delayed) 
 Dose reduction 
 Dose increase 
 Dose unchanged 
 Unknown 
 Not applicable 
 Interruption (temporary, 
permanent, or delayed) 
 Dose reduction 
 Dose increase 
 Dose unchanged 
 Unknown 
 Not applicable 
 Interruption (temporary, 
permanent, or delayed) 
 Dose reduction 
 Dose increase 
 Dose unchanged 
 Unknown 
 Not applicable 
Did an AE/SAE re-appear during re-administration of the drug? 
  Yes   
 No   
 Unknown  
 Not applicable  
If yes, which AE(s)/SAE(s):  
Event history (narrative): Please provide any relevant information concerning this event and that is not reported in another field of this form (circumstances, chronology; diagnosis 
and symptomatic treatment). If you do not have enough space, use several copies of this page. 
Centre employee in charge of notification 
for the centre:  
 
 
 
 
 
 
Last and first names IN BLOCK CAPITALS 
 
 
Date 
 
Address: 
 
 
 
 
 
 
 
 
 
Street 
 
Town 
 
Post code 
 
Country 
 
Phone no.: 
 
Fax no.: 
 
Email: 
 
Investigator's name if different: 
 
Date investigator (or notifier) informed: 
_____-_____-_____ 
Investigator's signature: 
 
 DD 
MMM 
YYYY 

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14.9. Appendix 9: "Morisky" patient self-questionnaire (Sutent® treatment 
compliance) 
 
 
Questionnaire concerning your treatment  
 
(tick a single answer per question) 
 
 
Yes 
 
No 
 
 Do you ever forget to take your medicines? 
 
 
 
 
 
 Do you even have problems remembering to take your 
medicines?  
 
 
 When you feel better, do you sometimes stop taking your 
medicines? 
 
 
 Sometimes, if you feel worse after taking your medicines, do you 
stop taking them?  
 
 
 
 
 
 
 
 
Additional question concerning adverse events 
 
 
Yes 
 
No 
 
 When you suffer an adverse event, do you ever reduce or adapt 
the treatment?  
 
 
 
 
 
 

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14.10. Appendix 10: "Physician" call centre satisfaction evaluation questionnaire 
- 
Collected via the e-CRF at the end of the last follow-up visit (end-of-study visit) 
- 
3 dimensions evaluated 
 
Very satisfied 
Satisfied 
Not very 
satisfied
Not satisfied 
No opinion 
Satisfaction concerning advice 
 Do you consider that your patient's support by a call centre helped 
reduce the number and/or frequency of grade 3 and 4 AEs thanks 
to the advice provided?  
 
 
 
 
 
 Do you consider that your patient's support by a call centre helped 
improve treatment compliance? 
 
 
 
 
 
 How satisfied or dissatisfied are you with your patient's change in 
quality of life thanks to the advice provided by the call centre?  
 
 
 
 
 
Satisfaction concerning management 
 
 
 
 
 
 Do you consider that your patient's support by a call centre helped 
reduce your workload?  
 
 
 
 
 
Overall satisfaction 
 
 
 
 
 
 Overall, how satisfied or dissatisfied are you with the management 
of your patient by the call centre?  
 
 
 
 
 
Do you have any comment to make  
□1   Yes  □0   No 
 
 
 
Where possible, would you wish to continue this type of support? 
□1   yes, absolutely 
□2   maybe 
□3   not really 
□4   not at all  
□5   no opinion 
14.11. Appendix 11: "Patient" call centre satisfaction evaluation questionnaire 
- 
Collected via a self-questionnaire at the end of the last follow-up visit (end-of-study 
visit) 
- 
4 dimensions evaluated 
 
Very satisfied 
Satisfied 
Not very 
satisfied
Not satisfied 
No opinion 

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Satisfaction concerning advice 
 How satisfied or dissatisfied were you with the prevention advice 
you received from the call centre to avoid serious adverse events 
associated with your Sutent® treatment? 
 How satisfied or dissatisfied were you with the treatments 
recommended by the call centre to reduce / limit the side effects 
associated with your Sutent® treatment? 
 
 
 
 
 
 How satisfied or dissatisfied were you with the call centre's ability 
to direct you to a general practitioner / oncologist when your 
situation required it?  
 
 
 
 
 
Satisfaction concerning management 
 How satisfied or dissatisfied were you with the explanations given 
by the call centre concerning your disease, your treatment and/or 
their side effects?  
 
 
 
 
 
Satisfaction concerning the service 
 Were you satisfied or dissatisfied with the interest shown by the 
call centre nurses in what you were saying, in your problems and in 
yourself? 
 
 
 
 
 
 Do you consider that the frequency, duration and number of 
follow-up calls that you received from the call centre were adapted 
to your situation?  
 
 
 
 
 
 How satisfied or dissatisfied were you with the availability of the 
call centre nurses via the freephone number provided - ease of 
contacting the freephone number, answer speed, recall if message 
on voice mail, wait time, etc.? 
 
 
 
 
 
Overall satisfaction 
 Overall, how satisfied or dissatisfied are you with the support you 
received by the call centre supporting you in management of your 
Sutent® treatment?  
 
 
 
 
 
 
Do you have any comment to make  
□1   Yes  □0   No 
 
 
 
 
 
 
Where possible, would you wish to continue this type of support? 
 □1   yes, absolutely 

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□2   maybe 
□3   not really 
□4   not at all  
□5   no opinion 
 
 
Would you recommend this type of follow-up to a friend or family member? 
 □1   yes, absolutely 
□2   maybe 
□3   not really 
□4   not at all  
□5   no opinion 
 
Do you consider that you needed the advice and actions proposed by the call centre 
throughout the duration of your participation in this study?  
 
 Yes No 
If not: When do you think you became independent concerning management of your treatment and its side 
effects?  ___________________