Trial Outcomes & Findings for PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A (NCT NCT02492984)
NCT ID: NCT02492984
Last Updated: 2017-04-04
Results Overview
Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).
COMPLETED
PHASE4
85 participants
From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).
2017-04-04
Participant Flow
As there were 2 participants who rolled over from the surgical prophylaxis group to the on-demand group should be counted once in total column, the total number of baseline participants was 85.
Participant milestones
| Measure |
On-Demand Group
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
14
|
|
Overall Study
COMPLETED
|
70
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
On-Demand Group
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
Baseline characteristics by cohort
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.2 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
21.0 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
9.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).Population: The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).
Outcome measures
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Percentage of Participants With Factor VIII (FVIII) Inhibitors
|
8.22 percentage of participants
Interval 3.08 to 17.04
|
7.14 percentage of participants
Interval 0.18 to 33.87
|
SECONDARY outcome
Timeframe: From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).Population: The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Outcome measures
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants with AEs
|
65 participants
|
10 participants
|
|
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants with SAEs
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.Population: Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.
Outcome measures
| Measure |
On-Demand Group
n=2568 infusions
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Response Assessment of On-Demand Treatment of Bleeds
Excellent
|
46.9 percentage of infusions
|
—
|
|
Response Assessment of On-Demand Treatment of Bleeds
Good
|
40.0 percentage of infusions
|
—
|
|
Response Assessment of On-Demand Treatment of Bleeds
Moderate
|
12.7 percentage of infusions
|
—
|
|
Response Assessment of On-Demand Treatment of Bleeds
No Response
|
0.3 percentage of infusions
|
—
|
|
Response Assessment of On-Demand Treatment of Bleeds
Data Not Recorded
|
0.1 percentage of infusions
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.Population: Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).
Outcome measures
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment
|
1.6 infusions
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.Population: Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
The number of bleeds resolved with 1, 2, 3, 4, or \>4 infusions was reported for each of the categories (1, 2, 3, 4, or \>4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all participants.
Outcome measures
| Measure |
On-Demand Group
n=1610 bleeds
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
1 Infusion
|
63.0 percentage of bleeds
|
—
|
|
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
2 Infusions
|
21.9 percentage of bleeds
|
—
|
|
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
3 Infusions
|
8.6 percentage of bleeds
|
—
|
|
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
4 Infusions
|
6.0 percentage of bleeds
|
—
|
|
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
>4 Infusions
|
0.5 percentage of bleeds
|
—
|
SECONDARY outcome
Timeframe: From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)Population: Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group".
Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.
Outcome measures
| Measure |
On-Demand Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Day of Surgery: Excellent
|
71.4 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Day of Surgery: Good
|
28.6 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Day of Surgery: Moderate
|
0 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Day of Surgery: None
|
0 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Post-Operative: Excellent
|
75.5 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Post-Operative: Good
|
24.5 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Post-Operative: Moderate
|
0 percentage of observations
|
—
|
|
Hemostatic Efficacy for Surgical Prophylaxis Treatment
Post-Operative: None
|
0 percentage of observations
|
—
|
SECONDARY outcome
Timeframe: From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)Population: Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group". Number of participants analyzed signifies participants evaluable for this outcome measure.
Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant.
Outcome measures
| Measure |
On-Demand Group
n=13 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Actual Estimated Blood Loss for Surgical Prophylaxis Treatment
Abnormal
|
0 partcipants
|
—
|
|
Actual Estimated Blood Loss for Surgical Prophylaxis Treatment
Normal
|
13 partcipants
|
—
|
|
Actual Estimated Blood Loss for Surgical Prophylaxis Treatment
Absence
|
0 partcipants
|
—
|
SECONDARY outcome
Timeframe: From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)Population: Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group".
Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable.
Outcome measures
| Measure |
On-Demand Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints.Population: All participants who received at least one dose of Xyntha during the study
The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).
Outcome measures
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment
Average Infusion Dose
|
674.68 International Unit (IU)
Standard Deviation 357.613
|
1245.07 International Unit (IU)
Standard Deviation 494.268
|
|
Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment
Total FVIII Consumption per Participant
|
25211.0 International Unit (IU)
Standard Deviation 22035.35
|
39860.7 International Unit (IU)
Standard Deviation 27546.15
|
SECONDARY outcome
Timeframe: From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first.Population: The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
LETE occurred in the on-demand setting if 2 successive "No Response" ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included.
Outcome measures
| Measure |
On-Demand Group
n=1610 bleeding episodes
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting
|
0.06 percentage of bleeding episodes
Interval 0.0 to 0.35
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.Population: The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.
Outcome measures
| Measure |
On-Demand Group
n=73 Participants
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 Participants
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
|---|---|---|
|
Number of Confirmed LETE in the Low Recovery Setting
|
0 LETE bleeds
|
0 LETE bleeds
|
Adverse Events
On-Demand Group
Surgical Prophylaxis Group
Total
Serious adverse events
| Measure |
On-Demand Group
n=73 participants at risk
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 participants at risk
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
Total
n=85 participants at risk
Treatment Group Description TBD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
8.2%
6/73
|
7.1%
1/14
|
8.2%
7/85
|
|
Injury, poisoning and procedural complications
Gingival injury
|
1.4%
1/73
|
0.00%
0/14
|
1.2%
1/85
|
Other adverse events
| Measure |
On-Demand Group
n=73 participants at risk
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
|
Surgical Prophylaxis Group
n=14 participants at risk
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
|
Total
n=85 participants at risk
Treatment Group Description TBD
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
5.5%
4/73
|
0.00%
0/14
|
4.7%
4/85
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/73
|
14.3%
2/14
|
2.4%
2/85
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/73
|
7.1%
1/14
|
2.4%
2/85
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
General disorders
Local swelling
|
5.5%
4/73
|
0.00%
0/14
|
4.7%
4/85
|
|
General disorders
Peripheral swelling
|
20.5%
15/73
|
0.00%
0/14
|
17.6%
15/85
|
|
General disorders
Pyrexia
|
20.5%
15/73
|
14.3%
2/14
|
20.0%
17/85
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Infections and infestations
Nasopharyngitis
|
24.7%
18/73
|
0.00%
0/14
|
21.2%
18/85
|
|
Infections and infestations
Tonsillitis
|
8.2%
6/73
|
7.1%
1/14
|
8.2%
7/85
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
7/73
|
0.00%
0/14
|
8.2%
7/85
|
|
Injury, poisoning and procedural complications
Contusion
|
8.2%
6/73
|
0.00%
0/14
|
7.1%
6/85
|
|
Injury, poisoning and procedural complications
Fall
|
12.3%
9/73
|
0.00%
0/14
|
10.6%
9/85
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/73
|
28.6%
4/14
|
4.7%
4/85
|
|
Injury, poisoning and procedural complications
Joint injury
|
6.8%
5/73
|
0.00%
0/14
|
5.9%
5/85
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.5%
4/73
|
0.00%
0/14
|
4.7%
4/85
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.9%
24/73
|
14.3%
2/14
|
30.6%
26/85
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
4.1%
3/73
|
7.1%
1/14
|
4.7%
4/85
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.5%
4/73
|
0.00%
0/14
|
4.7%
4/85
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
46.6%
34/73
|
21.4%
3/14
|
43.5%
37/85
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
15.1%
11/73
|
0.00%
0/14
|
12.9%
11/85
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.7%
18/73
|
0.00%
0/14
|
21.2%
18/85
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/73
|
14.3%
2/14
|
2.4%
2/85
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.7%
10/73
|
0.00%
0/14
|
11.8%
10/85
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.3%
9/73
|
0.00%
0/14
|
10.6%
9/85
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/73
|
7.1%
1/14
|
1.2%
1/85
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
8.2%
6/73
|
0.00%
0/14
|
7.1%
6/85
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from completion/termination at all participating sties. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER