Trial Outcomes & Findings for A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters (NCT NCT00396318)
NCT ID: NCT00396318
Last Updated: 2011-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
251 participants
Primary outcome timeframe
120 minutes after first dose
Results posted on
2011-04-27
Participant Flow
Five patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 246.
Participant milestones
| Measure |
Tenecteplase
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
At Least One Dose of Tenecteplase (MITT)
STARTED
|
246
|
|
At Least One Dose of Tenecteplase (MITT)
COMPLETED
|
241
|
|
At Least One Dose of Tenecteplase (MITT)
NOT COMPLETED
|
5
|
|
48- to 96-Hour Follow-Up Period
STARTED
|
246
|
|
48- to 96-Hour Follow-Up Period
COMPLETED
|
241
|
|
48- to 96-Hour Follow-Up Period
NOT COMPLETED
|
5
|
|
7-Day Post-Treatment Contact
STARTED
|
241
|
|
7-Day Post-Treatment Contact
COMPLETED
|
240
|
|
7-Day Post-Treatment Contact
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tenecteplase
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
At Least One Dose of Tenecteplase (MITT)
Subject withdrew consent
|
5
|
Baseline Characteristics
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Baseline characteristics by cohort
| Measure |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Age Continuous
|
43.6 Years
STANDARD_DEVIATION 26.4 • n=5 Participants
|
|
Age, Customized
< 2 years
|
10 participants
n=5 Participants
|
|
Age, Customized
≥ 2 to < 17 years
|
62 participants
n=5 Participants
|
|
Age, Customized
≥ 17 to < 65 years
|
111 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
63 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 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 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase
|
72.0 percentage of participants
Interval 66.3 to 77.6
|
SECONDARY outcome
Timeframe: 15 minutes after first dosePopulation: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase
|
29.3 percentage of participants
Interval 23.6 to 35.0
|
SECONDARY outcome
Timeframe: 30 minutes after first dosePopulation: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase
|
53.3 percentage of participants
Interval 47.0 to 59.5
|
SECONDARY outcome
Timeframe: 15 minutes after second dosePopulation: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase
|
76.4 percentage of participants
Interval 71.1 to 81.7
|
SECONDARY outcome
Timeframe: 30 minutes after second dosePopulation: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase
|
78.5 percentage of participants
Interval 73.3 to 83.6
|
SECONDARY outcome
Timeframe: 120 minutes after second dosePopulation: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase
|
81.3 percentage of participants
Interval 76.4 to 86.2
|
SECONDARY outcome
Timeframe: Up to 120 minutes post-treatment (Dose 1 or Dose 2)Population: 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 |
Tenecteplase
n=246 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase
Through first tenecteplase instillation
|
72.0 percentage of participants
Interval 66.3 to 77.6
|
|
Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase
Through second tenecteplase instillation
|
81.3 percentage of participants
Interval 76.4 to 86.2
|
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 |
Tenecteplase
n=137 Participants
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
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Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates 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
|
81.0 percentage of participants
Interval 74.5 to 87.6
|
Adverse Events
Tenecteplase
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenecteplase
n=246 participants at risk
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
General disorders
Pyrexia
|
0.81%
2/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Immune system disorders
Hypersensitivity
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Catheter Related Infection
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Dehydration
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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 |
Tenecteplase
n=246 participants at risk
2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
3/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Febrile Neutropenia
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Eye disorders
Conjunctivitis
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Eye disorders
Eye Discharge
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.81%
2/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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 Distension
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Constipation
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
1.6%
4/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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 Related Complication
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Injection Site Erythema
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Pain
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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.
|
|
Immune system disorders
Graft Versus Host Disease
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Nasopharyngitis
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Otitis Media
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Rash Pustular
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Streptococcal Bacteraemia
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Muscle Spasms
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Dysuria
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Urinary Retention
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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
Increased Upper Airway Secretion
|
0.41%
1/246 • The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
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