Trial Outcomes & Findings for A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters (NCT NCT00396253)
NCT ID: NCT00396253
Last Updated: 2017-01-12
Results Overview
Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to -280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.
Results posted on
2017-01-12
Participant Flow
Participant milestones
| Measure |
Tenecteplase
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
|
Overall Study
STARTED
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223
|
|
Overall Study
COMPLETED
|
210
|
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Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Tenecteplase
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Overall Study
Protocol Violation
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1
|
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Overall Study
Withdrawal by Subject
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7
|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Change in eligibility status
|
1
|
Baseline Characteristics
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
Baseline characteristics by cohort
| Measure |
Tenecteplase
n=223 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Age, Customized
< 17 years
|
1 participants
n=5 Participants
|
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Age, Customized
>= 17 years to < 65 years
|
120 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
102 participants
n=5 Participants
|
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Age, Continuous
|
61.2 years
STANDARD_DEVIATION 16.3 • n=5 Participants
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Gender
Female
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124 Participants
n=5 Participants
|
|
Gender
Male
|
99 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.Population: Modified intent to treat (MITT) population, consisting of all enrolled patients who received at least one dose of study drug (tenecteplase).
Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to -280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.
Outcome measures
| Measure |
Tenecteplase
n=223 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
|
Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
|
34.1 Percentage of participants
|
PRIMARY outcome
Timeframe: From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2.Population: Modified intent to treat (MITT) population
The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.
Outcome measures
| Measure |
Tenecteplase
n=223 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Intracranial hemorrhage
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0 Events
|
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Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Major bleeding
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0 Events
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|
Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Embolic event
|
0 Events
|
|
Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Thrombosis
|
1 Events
|
|
Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Catheter-related blood stream infection
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2 Events
|
|
Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase
Catheter-related complication
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0 Events
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SECONDARY outcome
Timeframe: Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2).Population: Modified intent to treat (MITT) population, who had treatment success at Visit 1. The n equals the number of subjects who had treatment success at Visit 1 and had assessment of catheter function for the given visit or who had a missing assessment due to starting the Retreatment course.
For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).
Outcome measures
| Measure |
Tenecteplase
n=76 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3
Visit 2 (n=72)
|
69.4 percentage of participants
Interval 58.8 to 80.1
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Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3
Visit 3 (n=71)
|
62.0 percentage of participants
Interval 50.7 to 73.3
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SECONDARY outcome
Timeframe: At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed.Population: Modified intent to treat (MITT) population
The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows: (Pre-treatment BUN) - (Post-HD BUN) \* 100% / (Pre-treatment BUN) Pre-treatment URR was assessed within 30-60 minutes after the initiation of HD and does not represent a true baseline value.
Outcome measures
| Measure |
Tenecteplase
n=223 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1
|
23.8 percentage of participants
Interval 18.2 to 29.4
|
SECONDARY outcome
Timeframe: At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed.Population: Modified intent to treat (MITT) population who did not receive extended-dwell tenecteplase at Visit 1.
The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows: (Pre-HD BUN) - (Post-HD BUN) \* 100% / (Pre-HD BUN)
Outcome measures
| Measure |
Tenecteplase
n=107 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2
|
34.6 percentage of participants
Interval 25.6 to 43.6
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SECONDARY outcome
Timeframe: Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1.Population: Modified intent to treat (MITT) population
Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 - BFR at Baseline.
Outcome measures
| Measure |
Tenecteplase
n=223 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1
|
81.9 mL/min
Standard Deviation 123.84
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SECONDARY outcome
Timeframe: BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1.Population: Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.
Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to -280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.
Outcome measures
| Measure |
Tenecteplase
n=116 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2
|
49.1 percentage of participants
Interval 40.0 to 58.2
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SECONDARY outcome
Timeframe: Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2)Population: Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.
Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following: (Pre-HD BUN) - (Post-HD BUN) \* 100% / (Pre-HD BUN)
Outcome measures
| Measure |
Tenecteplase
n=116 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3
URR ≥ 65% at Visit 2
|
42.2 percentage of participants
Interval 33.3 to 51.2
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|
Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3
URR ≥ 65% at Visit 3
|
33.6 percentage of participants
Interval 25.0 to 42.2
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SECONDARY outcome
Timeframe: Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1).Population: Subjects in the MITT Population Treated with Extended-Dwell Tenecteplase at Visit 1
Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 - BFR at Baseline.
Outcome measures
| Measure |
Tenecteplase
n=116 Participants
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Change in Blood Flow Rate From Baseline to the End of HD at Visit 2
|
117.1 mL/minute
Standard Deviation 139.96
|
Adverse Events
Tenecteplase
Serious events: 9 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenecteplase
n=223 participants at risk
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
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|
General disorders
Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Bacteraemia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
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|
Infections and infestations
Catheter Bacteraemia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Gangrene
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Sepsis
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Hypertension
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
Other adverse events
| Measure |
Tenecteplase
n=223 participants at risk
At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
1.8%
4/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Asthenia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Catheter Site Erythema
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Catheter Site Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Chest Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Chills
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Feeling Hot
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Oedema Peripheral
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
General disorders
Pyrexia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Bacteraemia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Gangrene
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Abdominal Abscess
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Central Line Infection
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Injury, poisoning and procedural complications
Device Breakage
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Investigations
Body Temperature Increased
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.90%
2/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Nervous system disorders
Headache
|
1.8%
4/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.90%
2/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Hypertension
|
0.90%
2/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Hypotension
|
1.3%
3/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Haemodynamic Instability
|
0.90%
2/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Hot Flush
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.45%
1/223 • Begins at initiation of study treatment and ends upon completion of the second visit following the last administration of study treatment or at early termination from the study, whichever is earlier.
MITT population. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER