Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)

ClinicalTrials.gov ID

NCT01934452

Acronym / sponsor ID

APERCU / NRA6180080

Conditions

Complete Remission in Renal Cell Carcinoma

Keywords

complete remission

Study type

Observational

Recruitment status

Completed

Enrolment

77 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

21 May 2015 (actual)

Primary completion

19 Jan 2022 (actual)

Study completion

19 Jan 2022 (actual)

First posted

4 Sep 2013 (estimated)

Results

Posted 13 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case-control

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

18 to 99 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Time to Diagnose Metastatic Renal Cell Carcinoma

   Time frame: Baseline (at inclusion Visit)

   Time to diagnose metastatic renal cell carcinoma was defined as the duration between date of diagnosis of mRCC to date of inclusion visit.

2. Number of Participants Categorized According to Presence of Nephrectomy

   Time frame: Baseline (at inclusion Visit)

   In this outcome measure, participants were categorized according to presence of nephrectomy as yes or no.

3. Number of Participants Categorized According to Type of Nephrectomy

   Time frame: Baseline (at inclusion Visit)

   In this outcome measure, participants were categorized according to type of nephrectomy. Various types of nephrectomies included: extended or partial, nephrectomy with or without adrenalectomy, nephrectomy with or without curettage and open or laparoscopic nephrectomy.

4. Time to Nephrectomy From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)

   Time frame: Baseline (at inclusion Visit)

   In this outcome measure, time from diagnosis of mRCC to nephrectomy was reported.

5. Number of Participants Categorized According to Pathological Classification

   Time frame: Baseline (at inclusion Visit)

   In this outcome measure, participants were categorized according to pathological classification. Pathological classification included: clear cell carcinoma (yes or no), multilocular cystic renal clear cell carcinoma (yes or no), papillary cell carcinoma (yes or no), chromophobe cell carcinoma(yes or no), Bellini's collecting duct carcinoma(yes or no), medullary cell carcinoma (yes or no), sarcomatoid contingent (yes or no), and other (yes or no).

6. Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification

   Time frame: Baseline (at inclusion Visit)

   In this outcome measure, participants were categorized according to TNM classification. TNM classification included: T class (1, 2, 3, 4), N (0,1,2, x) and M class (0, 1). TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor (less than or equal to) <=20 millimeters (mm), T2: tumor >20 mm to <=50 mm, T3: >50 mm, T4: tumor invading other structures. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm.

7. Tumour Size

   Time frame: Baseline (at Inclusion Visit)

   Tumour size of participants was reported in this outcome measure.

8. Number of Participants Categorized According to Fuhrman Nuclear Grade

   Time frame: Baseline (at Inclusion Visit)

   In this outcome measure, participants were categorized according to Fuhrman nuclear grade. The grades were classified as: grade 1, 2, 3, and 4. The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells.

9. Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component

   Time frame: Baseline (at Inclusion Visit)

   In this outcome measure, participants were categorized according to presence of necrosis, pulmonary embolism and sarcomatoid component.

10. Time to Initiation of Sunitinib From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)

    Time frame: Diagnosis of mRCC to Sunitinib Initiation (at Inclusion Visit)

11. Number of Participants Categorized According to Location of Metastases

    Time frame: At initiation of sunitinib (at Inclusion Visit)

    In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal gland, pancreas, brain and lymph nodes). Participant can have more than 1 location of metastases.

12. Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site

    Time frame: At initiation of sunitinib (at Initiation Visit)

    In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site.

13. Number of Participants Categorized According to Recurrence at Nephrectomy Site

    Time frame: At initiation of sunitinib (at Inclusion Visit)

    In this outcome measure, participants were categorized according to recurrence at nephrectomy site were reported.

14. Number of Participants Categorized According to Recurrence at Other Site

    Time frame: At initiation of sunitinib (at Inclusion Visit)

    In this outcome measure, participants were categorized according to recurrence at any other site than nephrectomy site were reported.

15. Number of Metastatic Sites

    Time frame: At initiation of sunitinib (at Initiation Visit)

    In this outcome measure, median of metastatic sites were reported.

16. Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification

    Time frame: At initiation of sunitinib (at Inclusion Visit)

    In this outcome measure, participants were categorized according MSKCC prognostic classification. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <lower limit of normal (LLN); lactate dehydrogenase >1.5*upper limit of normal (ULN); corrected serum calcium >10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: good prognosis (0 factor), intermediate prognosis (1-2 factors), poor prognosis (>=2 factors).

17. Time to Achieve Complete Remission (CR) After Sunitinib Initiation: mRCC Participants With CR

    Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

    In this outcome measure, time taken by participants to achieve the complete remission after sunitinib initiation were reported. As per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to size of <10 millimeter (mm).

18. Number of Participants Categorized According to Method of Achieving CR: mRCC Participants With CR

    Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

    In this outcome measure, participants were categorized according to the method of achieving the CR. Different methods included: treatment combined with local treatment and medical treatment alone. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

19. Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR

    Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

    In this outcome measure, participants were categorized according to the type of medical treatment alone as method of achieving the CR. Medical treatment alone included: surgery, radiotherapy, radiofrequency, cryoablation and metastasectomy. Only those categories in which at least 1 participant had data were reported. Participant could have received more than 1 type of medical treatment. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

20. Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR

    Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

    In this outcome measure, participants were categorized according to the type of treatment Combined With local treatment alone as method of achieving the CR. Type of treatment combined with local treatment included: surgery, surgery + radiotherapy + radiofrequency + metastasectomy, metastasectomy, metastasectomy + other, radiofrequency + metastasectomy + other and radiotherapy. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

21. Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR

    Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

    In this outcome measure, participants were categorized according to radiological assessment of the CR. It included: disappearance of all known target lesions, disappearance of all non-target lesions, no new lesions and all target and non-target lymph nodes. Only those categories with at least 1 participant as result are reported. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

22. Number of Participants Categorized According to Therapeutic Strategy After CR: mRCC Participants With CR

    Time frame: After achieving CR with sunitinib treatment (data collected at Inclusion Visit)

    In this outcome measure, participants were categorized according to therapeutic strategy after CR. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). It included discontinuation and continuation of sunitinib treatment.

23. Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up visit

    DE included:complete response, progression, stabilization and not assessed. Disease progression (PD):per RECIST v1.1: at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm.Appearance of 1 or more new lesions was also considered progression. CR:disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis) and stable disease (SD): absence of sufficient reduction for a partial response (PR): at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

24. Number of Participants With Ongoing Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, participants with ongoing sunitinib treatment were reported.

25. Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, participants with ongoing sunitinib treatment according to dose (25, 37.5 and 50 mg) and regimen (4/2 [4 weeks dosing then 2 weeks off] and 2/1 [4 weeks dosing then 2 weeks off]) were reported.

26. Number of Participants Who Discontinued Sunitinib Temporarily at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, participants who temporarily discontinued sunitinib were reported.

27. Number of Participants Categorized According to Number of Temporary Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, participants were categorized according to number (1 and 2) of temporary discontinuations of sunitinib.

28. Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, number of instances when different types of reasons led to temporary discontinuations like intolerance, local treatment and other reasons were reported. Participant could have temporarily discontinued sunitinib treatment more than once.

29. Number of Instances When Participants Resumed Sunitinib Treatment After Temporary Discontinuation at Month 12: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, number of instances when participants resumed sunitinib treatment were reported. Participant could have temporarily discontinued sunitinib treatment more than once and likewise resumed treatment more than once.

30. Duration of Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, duration of temporary discontinuation of sunitinib treatment were reported.

31. Number of Participants Who Discontinued Sunitinib Permanently at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, number of participants who permanently discontinued sunitinib were reported.

32. Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up visit

    In this outcome measure, participants were categorized according to reasons for permanent discontinuation of sunitinib.

33. Duration of Treatment With Sunitinib Since Complete Remission at Month 12 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 12 follow-up study visit

    In this outcome measure, duration of treatment with sunitinib since complete remission was reported.

34. Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

    DE included: CR, PD, SD and not assessed. PD: per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).SD: absence of sufficient reduction for PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

35. Number of Participants With Ongoing Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

    In this outcome measure, participants with ongoing sunitinib treatment were reported.

36. Number of Participants Who Discontinued Sunitinib Temporarily at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

    In this outcome measure, number of participants who temporarily discontinued sunitinib were reported.

37. Number of Participants Who Resumed Treatment at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

    In this outcome measure, participants who resumed sunitinib were reported.

38. Number of Days of Temporary Discontinuation of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

39. Number of Participants Who Discontinued Sunitinib Permanently at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

40. Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

41. Duration of Treatment With Sunitinib Since Complete Remission at Month 24 Follow-up Visit: mRCC Participants With CR

    Time frame: Month 24 follow-up study visit

    CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

42. Time to Progression With Sunitinib Treatment From Complete Remission: mRCC Participants With CR

    Time frame: From achieving CR with Sunitinib treatment (before inclusion in the study, participants recruited for 3 years) to Visit at progression (during study); [post inclusion follow-up in the study was maximum of 39.8 months for Cases]

    CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PD: =>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =>1 new lesions.

43. Duration of Additional Treatment With Sunitinib Since Complete Remission: mRCC Participants With CR

    Time frame: From complete remission (before inclusion in the study, participants recruited for 3 years) till discontinuation of additional treatment during this study; [post inclusion follow-up in the study was maximum of 39.8 months for Cases]

    CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

44. Number of Participants Categorized According to Types of Progression: mRCC Participants With CR

    Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

    As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

45. Number of Participants Categorized According to Site of Progression: mRCC Participants With CR

    Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

    As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

46. Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR

    Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

    In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal glands, pancreas, brain, lymph nodes, recurrence at nephrectomy site and other). Participant could have more than 1 location of metastases.

47. Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR

    Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

    In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site were reported.

48. Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR

    Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

    In this outcome measure, participants were categorized according to number of metastatic sites (1, 2 and 3).

49. Number of Participants Who Received Systemic Treatment After Progression: mRCC Participants With CR

    Time frame: After progression, during follow up period maximum of 39.8 months for Cases

    In this outcome measure, participants who received systemic treatment after progression were reported.

50. Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR

    Time frame: After progression, during follow up period maximum of 39.8 months for Cases

    In this outcome measure, participants who received systemic treatment after progression were categorized according to type of treatment. Different types of treatment were tyrosine kinase inhibitor- sunitinib restart, radiotherapy and other systemic treatment. Participant could have more than 1 type of treatment.

51. Number of Participants With Best Objective Response After Progression: mRCC Participants With CR

    Time frame: At the end of study visit follow-up (during follow up period maximum of 39.8 months for Cases)

    Participants with best objective response after progression were evaluated here. It included complete, partial, stabilized and not applicable. PD per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR:disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis) \& SD: absence of sufficient reduction for a PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

52. Duration of Treatment With First Line Sunitinib Till Progression: mRCC Participants With CR

    Time frame: Sunitinib initiation (before inclusion, participants recruited for 3 years) till progression (follow up period maximum of 39.8 months for Cases)

    CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

53. Number of Participants Who Were Early Terminated: mRCC Participants With CR

    Time frame: From inclusion in the study till termination (during follow up period maximum of 39.8 months for Cases)

    Participants who terminated study early were reported in this outcome measure.

54. Number of Participants Who Achieved Response: mRCC Participants With CR

    Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

55. Number of Participants Categorized According to Number of Subsequent Treatment Lines From Progression/Post Complete Remission: mRCC Participants With CR

    Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

56. Number of Participants Who Died: mRCC Participants With CR

    Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

    In this outcome measure, participants who died during the study were reported.

57. Progression Free Survival: mRCC Participants With CR

    Time frame: At the end of the study (inclusion period was of 3 years and follow up period maximum of 39.8 months for Cases)

    PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method.

58. Number of Participants With Adverse Events and Serious Adverse Events

    Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

59. Number of Participants With Adverse Events and Serious Adverse Events Possibly Related to Drug Exposure

    Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, possibly considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

60. Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs

    Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

14 sites in 1 country: see every site and its status.