An observational study in Metastatic/Advanced Renal Cell Carcinoma, sponsored by Pfizer. Completed at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-24.
Sponsored by Pfizer · Observational
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center
Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).
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)..
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 70 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The 100 metastatic and/or advanced patients of the study will come from the population of patients under the care of French renal cell carcinoma oncologists
Inclusion Criteria:
Man or woman aged 18 or over;
Non-inclusion criteria
Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
Other: Best supportive care · Other: call center
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.
Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.
Time frame: Baseline up to 6 months
Number of Participants With at Least 1 Sunitinib Dose Reduction
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.
Time frame: Baseline up to 6 months
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.
Time frame: Baseline up to 6 months
Average Sunitinib Dose Reduction
Time frame: Baseline up to 6 months
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
Time frame: Baseline up to 6 months
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
Time frame: Baseline up to 6 months
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.
Time frame: Baseline up to 6 months
Number of Participants Who Permanently Discontinued Sunitinib Treatment
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
Time frame: Baseline up to 6 months
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
Time frame: Baseline up to 6 months
Mean Duration of Sunitinib Treatment
Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
Time frame: Baseline up to 6 months
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles
Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped
Time frame: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Hospitalization
Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.
Time frame: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Consultation
Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.
Time frame: Baseline up to 6 months
Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.
Time frame: Baseline up to 6 months
Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.
Time frame: Baseline up to 6 months
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response
ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimetre \[mm\]). No new lesions. Partial response (PR) was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Baseline up to 6 months
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
Time frame: At the end of the study (At Month 6)
Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
Time frame: At the end of the study (At Month 6)
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
Time frame: At the end of the study (At Month 6)
Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
Time frame: Baseline up to 6 months
Total Number of Calls (Planned and Unplanned)
1 participant can call more than once during the study.
Time frame: Baseline up to 6 months
Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call
Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.
Time frame: First call made anytime from baseline up to 6 months
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call
Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.
Time frame: First call made anytime from baseline up to 6 months
Number of Telephone Calls Describing Actions Taken by Call Center
In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.
Time frame: Baseline up to 6 months
Number of Telephone Calls Where Participants Declared Adverse Events
In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.
Time frame: Baseline up to 6 months
| Milestone | Call Center | Standard of Care |
|---|---|---|
| Started | 42 | 27 |
| Completed | 29 | 13 |
| Not completed | 13 | 14 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Toxicity | 6 | 5 |
| Withdrew: Participant choice | 1 | 0 |
| Withdrew: Doctor choice | 1 | 0 |
| Withdrew: Progressive disease | 4 | 8 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | 34 | 14 |
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Number of Participants With at Least 1 Sunitinib Dose Reduction | 12 | 4 |
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Adverse Event | 12 | 3 |
| Unknown | 0 | 1 |
| milligram per day (mg/day) | Call Center | Standard of Care |
|---|---|---|
| Average Sunitinib Dose Reduction | 12.5 ± 0 | 12.5 ± 0 |
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | 27 | 8 |
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
| days | Call Center | Standard of Care |
|---|---|---|
| Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment | 10.5 ± 11.5 | 16.6 ± 19.4 |
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.
| Participants | Call Center | Standard of Care |
|---|---|---|
| AE | 19 | 7 |
| Surgery | 1 | 0 |
| Omission | 4 | 0 |
| Doctor choice | 6 | 1 |
| Other | 2 | 1 |
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Number of Participants Who Permanently Discontinued Sunitinib Treatment | 13 | 14 |
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Progressive Disease | 4 | 8 |
| Toxicity | 6 | 5 |
| Participant Choice | 1 | 0 |
| Doctor's Choice | 1 | 0 |
| Death | 1 | 1 |
Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
| Months | Call Center | Standard of Care |
|---|---|---|
| Mean Duration of Sunitinib Treatment | 4.8 ± 1.9 | 4.2 ± 1.9 |
Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped
| Participants | Call Center | Standard of Care |
|---|---|---|
| 1 Cycle | 6 | 3 |
| 2 Cycles | 1 | 7 |
| 3 Cycles | 7 | 5 |
| 4 Cycles | 28 | 12 |
Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.
| Participants | Call Center |
|---|---|
| Number of Participants With At Least 1 Unplanned Hospitalization | 9 |
Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.
| Participants | Call Center |
|---|---|
| Number of Participants With At Least 1 Unplanned Consultation | 16 |
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.
| Participants | Call Center | Standard of Care |
|---|---|---|
| Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | 30 | 15 |
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.
| Units on a scale | Call Center | Standard of Care |
|---|---|---|
| Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | 0.1 ± 0.5 | 0.2 ± 0.4 |
ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimetre \[mm\]). No new lesions. Partial response (PR) was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
| Percentage of participants | Call Center |
|---|---|
| Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response | 33.3 |
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
| Units on a scale | Call Center |
|---|---|
| Satisfaction with the advice | 1.2 ± 0.9 |
| Satisfaction with care | 1.1 ± 1.1 |
| Satisfaction with the service | 1.2 ± 0.9 |
| Overall satisfaction with support in management | 1.2 ± 0.9 |
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
| Participants | Call Center |
|---|---|
| Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | 19 |
Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
| Units on a scale | Physicians |
|---|---|
| Satisfaction with the advice | 0.4 ± 1.1 |
| Satisfaction with care | -0.6 ± 1.2 |
| Overall satisfaction of participant care | 0.1 ± 1.4 |
Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
| Physicians | Physicians |
|---|---|
| Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | 7 |
1 participant can call more than once during the study.
| Calls | Call Center |
|---|---|
| Total Number of Calls (Planned and Unplanned) | 431 |
Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.
| Participants | Call Center |
|---|---|
| Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call | 33 |
Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.
| Participants | Call Center |
|---|---|
| Doctor clearly explained how to take treatment | 31 |
| Participants given documentation about treatment | 31 |
| Doctor explain manage side effect due to treatment | 27 |
| Prescriptions for supportive medical treatments | 27 |
In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.
| Telephone calls | Call Center |
|---|---|
| Advice about managing treatment: taking Sunitinib | 266 |
| Advice about managing treatment:Sunitinib followup | 281 |
| Advice about managing treatment: Reporting any AE | 341 |
| General preventative advice: taking treatments | 263 |
| General preventative advice: Lifestyle advice | 278 |
| General preventative advice: Food/dietetic advice | 222 |
| General preventative advice: Orodental hygiene | 272 |
| Specific advice for type of AE: skin toxicities | 270 |
| Specific advice for type of AE: GI disorders | 271 |
| Specific advice for type of AE: cardiac disorders | 317 |
| Specific advice for type of AE: infectious problem | 233 |
| Specific advice for type of AE:preventative advice | 289 |
| Actions to participants:Do not forget consultation | 134 |
| Actions to participants: additional investigation | 137 |
In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.
| Telephone calls | Call Center |
|---|---|
| Number of Telephone Calls Where Participants Declared Adverse Events | 280 |
Collected over Baseline up to 6 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Call Center | 2/42 (4.8%) | 12/42 (28.6%) | 42/42 (100%) |
| Standard of Care | 3/27 (11.1%) | 15/27 (55.6%) | 27/27 (100%) |
| Event | Call Center | Standard of Care |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/42 | 4/27 |
| Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/42 | 2/27 |
| HaematuriaRenal and urinary disorders | 1/42 | 2/27 |
| HypertensionVascular disorders | 3/42 | 0/27 |
| PyrexiaGeneral disorders | 2/42 | 0/27 |
| Cerebrovascular AccidentNervous system disorders | 2/42 | 0/27 |
| Renal FailureRenal and urinary disorders | 2/42 | 0/27 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/42 | 1/27 |
| Adrenal InsufficiencyEndocrine disorders | 0/42 | 1/27 |
| AstheniaGeneral disorders | 1/42 | 1/27 |
| Event | Call Center | Standard of Care |
|---|---|---|
| HypertensionVascular disorders | 33/42 | 10/27 |
| Decreased AppetiteMetabolism and nutrition disorders | 27/42 | 7/27 |
| DysgeusiaNervous system disorders | 27/42 | 5/27 |
| FatigueGeneral disorders | 26/42 | 4/27 |
| DiarrhoeaGastrointestinal disorders | 24/42 | 5/27 |
| NauseaGastrointestinal disorders | 24/42 | 4/27 |
| AstheniaGeneral disorders | 22/42 | 15/27 |
| Mucosal InflammationGeneral disorders | 16/42 | 10/27 |
| VomitingGastrointestinal disorders | 15/42 | 3/27 |
| Weight DecreasedInjury, poisoning and procedural complications | 15/42 | 1/27 |
Safety population included participants treated with Sunitinib.
| Age, Continuous(years) | Call Center | Standard of Care | Total |
|---|---|---|---|
| Mean | 67.2 ± 10.3 | 65.6 ± 9.2 | 66.6 ± 9.8 |
| Sex: Female, Male(Participants) | Call Center | Standard of Care | Total |
|---|---|---|---|
| Female | 12 | 5 | 17 |
| Male | 30 | 22 | 52 |
| Race and Ethnicity Not Collected(Participants) | Call Center | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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