Trial Outcomes & Findings for Study Investigating Rapamune For Post-Marketing Surveillance (NCT NCT00484094)
NCT ID: NCT00484094
Last Updated: 2017-01-16
Results Overview
All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
Recruitment status
COMPLETED
Target enrollment
209 participants
Primary outcome timeframe
Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
Results posted on
2017-01-16
Participant Flow
Participants were enrolled between July 2011 and June 2015 from Korean health care centers.
Participant milestones
| Measure |
Rapamune
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Overall Study
STARTED
|
209
|
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Overall Study
COMPLETED
|
167
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Rapamune
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Overall Study
Discontinued
|
39
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Overall Study
Other
|
3
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Baseline Characteristics
Study Investigating Rapamune For Post-Marketing Surveillance
Baseline characteristics by cohort
| Measure |
Rapamune
n=209 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Age, Continuous
|
47.93 Years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
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Gender
Female
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81 Participants
n=5 Participants
|
|
Gender
Male
|
128 Participants
n=5 Participants
|
|
Type of Transplantation
Primary Transplantation
|
199 Participants
n=5 Participants
|
|
Type of Transplantation
Secondary Transplantation
|
10 Participants
n=5 Participants
|
|
Type of Donation
Cadaveric
|
76 Participants
n=5 Participants
|
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Type of Donation
Living
|
132 Participants
n=5 Participants
|
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Type of Donation
Unknown
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.Population: Safety Analysis Set
All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
Outcome measures
| Measure |
Rapamune
n=209 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
AEs
|
54.07 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
ADRs
|
43.06 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
SAEs
|
7.66 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
SADRs
|
2.87 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Unexpected SAEs
|
2.39 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Unexpected SADRs
|
0.48 Percentage of participants
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PRIMARY outcome
Timeframe: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.Population: This analysis was not performed because laboratory data were not collected during the study.
Laboratory test was not mandatory because this study was a non-interventional study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.Population: Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.
Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.
Outcome measures
| Measure |
Rapamune
n=209 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
|
3.35 Percentage of participants
Interval 0.91 to 5.79
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SECONDARY outcome
Timeframe: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.Population: Efficacy Analysis Set; Participants who had available data.
The investigator recorded the participant's survival status and evaluation date on the CRF.
Outcome measures
| Measure |
Rapamune
n=206 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Percentage of Participants Alive
|
99.51 Percentage of participants
Interval 98.57 to 100.0
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SECONDARY outcome
Timeframe: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.Population: Efficacy Analysis Set; Participants who had available data.
Graft survival was defined as not showing graft loss at the time of evaluation.
Outcome measures
| Measure |
Rapamune
n=206 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Percentage of Participants With Survived Graft
|
99.51 Percentage of participants
Interval 98.57 to 100.0
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SECONDARY outcome
Timeframe: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.Population: Efficacy Analysis Set.
Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.
Outcome measures
| Measure |
Rapamune
n=209 Participants
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula
|
67.07 mL/min
Interval 4.8 to 113.27
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Adverse Events
Rapamune
Serious events: 16 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapamune
n=209 participants at risk
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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General disorders
Ascites
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
2/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Plasma osmolality increased
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Angina pectoris aggravated
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Transplant rejection
|
0.96%
2/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Azotaemia
|
1.9%
4/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.96%
2/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Polyomavirus infection
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Cystitis
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Infection susceptibility increased
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.48%
1/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Rapamune
n=209 participants at risk
Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
4/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
10/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
3/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
3.3%
7/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis ulcerative
|
3.3%
7/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
3/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
11.5%
24/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
1.4%
3/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.8%
10/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.9%
4/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
1.4%
3/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Transplant rejection
|
1.9%
4/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.4%
5/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
4/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Azotaemia
|
2.9%
6/209 • Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60