Trial Outcomes & Findings for A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters (NCT NCT00395876)
NCT ID: NCT00395876
Last Updated: 2010-08-10
Results Overview
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
120 minutes after first dose
Results posted on
2010-08-10
Participant Flow
Three patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 97.
Participant milestones
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Baseline characteristics by cohort
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 2 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
≥ 2 to < 17 years
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
≥ 17 to < 65 years
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Age Continuous
|
42.2 years
STANDARD_DEVIATION 28.3 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 26.6 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 minutes after first dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug
|
23.4 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 minutes after first dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
|
10.6 percentage of participants
|
22.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 minutes after first dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
|
19.1 Percentage of patients
|
44.0 Percentage of patients
|
SECONDARY outcome
Timeframe: 15 minutes after second dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
|
42.6 percentage of participants
Interval 28.4 to 56.7
|
70.0 percentage of participants
Interval 57.3 to 82.7
|
SECONDARY outcome
Timeframe: 30 minutes after second dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
|
63.8 Percentage of patients
Interval 50.1 to 77.6
|
82.0 Percentage of patients
Interval 71.4 to 92.6
|
SECONDARY outcome
Timeframe: 120 minutes after second dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
|
72.3 Percentage of patients
Interval 59.6 to 85.1
|
88.0 Percentage of patients
Interval 79.0 to 97.0
|
SECONDARY outcome
Timeframe: 15 minutes after third dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
|
83.0 percentage of participants
Interval 72.2 to 93.7
|
88.0 percentage of participants
Interval 79.0 to 97.0
|
SECONDARY outcome
Timeframe: 30 minutes after third dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
|
85.1 Percentage of patients
Interval 74.9 to 95.3
|
88.0 Percentage of patients
Interval 79.0 to 97.0
|
SECONDARY outcome
Timeframe: 120 minutes after third dosePopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
|
85.1 Percentage of patients
Interval 74.9 to 95.3
|
88.0 Percentage of patients
Interval 79.0 to 97.0
|
SECONDARY outcome
Timeframe: Up to 120 minutes post-treatmentPopulation: Modified intent to treat (MITT) population
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase
Through first tenecteplase instillation
|
72.3 percentage of participants
Interval 59.6 to 85.1
|
60.0 percentage of participants
Interval 46.4 to 73.6
|
|
Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase
Through second tenecteplase instillation
|
85.1 percentage of participants
Interval 74.9 to 95.3
|
88.0 percentage of participants
Interval 79.0 to 97.0
|
SECONDARY outcome
Timeframe: Up to 7 days post-treatmentPopulation: Number of patients (from MITT population) with restored CVC function during the treatment period
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Outcome measures
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=27 Participants
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=29 Participants
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase
|
81.5 Percentage of patients
Interval 66.8 to 96.1
|
79.3 Percentage of patients
Interval 64.6 to 94.1
|
Adverse Events
Placebo + Tenecteplase + Tenecteplase (PTT)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Tenecteplase + Tenecteplase + Placebo (TTP)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 participants at risk
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 participants at risk
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Psychiatric disorders
Mental Status Changes
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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 |
Placebo + Tenecteplase + Tenecteplase (PTT)
n=47 participants at risk
Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
Tenecteplase + Tenecteplase + Placebo (TTP)
n=50 participants at risk
Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
1/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Bradypnoea
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Laryngospasm
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Pneumothorax
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Dry Skin
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Rash
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
|
2.1%
1/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Haematoma
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Syncope
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Cardiac disorders
Tachycardia
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
|
2.1%
1/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
4.0%
2/50
Modified intent to treat (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
Abdonimal Pain
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Abdominal Pain Upper
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Epigastric Discomfort
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Nausea
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Stomatitis
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
4.0%
2/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Axillary Pain
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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 Oedema
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Fatigue
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Escherichia Sepsis
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Blood Lactate Dehydrogenase Increased
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Platelet Count Decreased
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
Weight Decreased
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Metabolism and nutrition disorders
Hypertriglycerideaemia
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Bone Pain
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Neck Pain
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Pain in Extremity
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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
Dizziness
|
0.00%
0/47
Modified intent to treat (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.
|
4.0%
2/50
Modified intent to treat (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
Burning Sensation
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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.
|
|
Psychiatric disorders
Agitation
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/47
Modified intent to treat (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.
|
2.0%
1/50
Modified intent to treat (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.
|
|
Renal and urinary disorders
Glycosuria
|
2.1%
1/47
Modified intent to treat (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.
|
0.00%
0/50
Modified intent to treat (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