Trial Outcomes & Findings for Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors (NCT NCT02756845)
NCT ID: NCT02756845
Last Updated: 2024-02-20
Results Overview
All toxicities were graded using the Common Terminology Criteria for Adverse Events version 4.0: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe/medically significant but not immediately life-threatening * Grade 4: Life-threatening * Grade 5: Death related to adverse event The occurrence of any of the below was considered a DLT, if judged to be related to talimogene laherparepvec: * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity that lasted \> 3 days despite optimal supportive care * Any ≥ grade 3 non-hematologic laboratory value if medical intervention was required, the abnormality led to hospitalization or the abnormality persisted for \> 1 week unless deemed not clinically important per both investigator \& sponsor * Febrile neutropenia grade 3/4 * Thrombocytopenia \< 25 x 10\^9/L associated with bleeding event that required intervention * Serious herpetic event * Grade 5 toxicity * Any intolerable toxicity that led to permanent discontinuation of talimogene laherparepvec
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Day 1 to Day 35
Results posted on
2024-02-20
Participant Flow
A total of 15 participants were enrolled across 11 centers in Belgium, Canada, France, Spain, Switzerland and the United States from August 2017 to November 2022.
Participant milestones
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
2
|
|
Overall Study
Received Talimogene Laherparepvec
|
13
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
2
|
Reasons for withdrawal
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Overall Study
Death
|
12
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
Baseline characteristics by cohort
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
9.0 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 35Population: DLT Analysis Set: all DLT evaluable participants defined as participants who had the opportunity to be followed for at least 35 days from the initial dosing of talimogene laherparepvec and received at least two treatments of talimogene laherparepvec (except participants who had a DLT after the first dose).
All toxicities were graded using the Common Terminology Criteria for Adverse Events version 4.0: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe/medically significant but not immediately life-threatening * Grade 4: Life-threatening * Grade 5: Death related to adverse event The occurrence of any of the below was considered a DLT, if judged to be related to talimogene laherparepvec: * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity that lasted \> 3 days despite optimal supportive care * Any ≥ grade 3 non-hematologic laboratory value if medical intervention was required, the abnormality led to hospitalization or the abnormality persisted for \> 1 week unless deemed not clinically important per both investigator \& sponsor * Febrile neutropenia grade 3/4 * Thrombocytopenia \< 25 x 10\^9/L associated with bleeding event that required intervention * Serious herpetic event * Grade 5 toxicity * Any intolerable toxicity that led to permanent discontinuation of talimogene laherparepvec
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=11 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Experienced a DLT
|
0.0 Percent of participants
Interval 0.0 to 28.5
|
0.0 Percent of participants
Interval 0.0 to 84.2
|
|
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Did Not Experience a DLT
|
100.0 Percent of participants
Interval 71.5 to 100.0
|
100.0 Percent of participants
Interval 15.8 to 100.0
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec.
ORR was defined as the percentage of participants who experienced either complete response (CR) or partial response (PR) per modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) response criteria. CR was defined as the disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as the decrease in tumor burdena ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
0.0 Percentage of participants
Interval 0.0 to 24.71
|
0.0 Percentage of participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec.
DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA Days
No participants experienced a response of CR or PR, so DOR could not be calculated.
|
NA Days
No participants experienced a response of CR or PR, so DOR could not be calculated.
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec.
TTR was defined as the number of days from the first dose of talimogene laherparepvec to the first objective assessment of response as per modified irRC-RECIST.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Time to Response (TTR)
|
NA Days
No participants experienced a response of CR or PR, so TTR could not be calculated.
|
NA Days
No participants experienced a response of CR or PR, so TTR could not be calculated.
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety analysis set: all participants who received at least one dose of talimogene laherparepvec.
TTP was defined as the time from the first dose of talimogene laherparepvec until objective tumor progression per irRC-RECIST. TTP was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Time to Progression (TTP)
|
2.50 Months
Interval 0.0 to 9.0
|
NA Months
Interval 1.6 to 3.5
Insufficient participants experienced disease progression, so the median could not be calculated.
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety analysis set: all participants who received at least one dose of talimogene laherparepvec.
PFS was defined as the time from the first dose to the earlier of disease progression per modified irRC-RECIST or death from any cause. PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.32 Months
Interval 1.1 to 11.6
|
6.42 Months
Interval 1.6 to 11.2
|
SECONDARY outcome
Timeframe: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 monthsPopulation: Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec.
OS was defined as as the time from first dose to the event of death from any cause. OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 Participants
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 Participants
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months.
Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Overall Survival (OS)
|
9.40 Months
Interval 1.1 to 54.5
|
8.02 Months
Interval 4.8 to 11.2
|
Adverse Events
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
Serious events: 5 serious events
Other events: 13 other events
Deaths: 12 deaths
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 participants at risk
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 participants at risk
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Vascular device infection
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma metastatic
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Vascular disorders
Hypovolaemic shock
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
Other adverse events
| Measure |
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
n=13 participants at risk
Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
n=2 participants at risk
Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Cardiac disorders
Sinus tachycardia
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Dry mouth
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
6/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Asthenia
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Chest pain
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Chills
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Face oedema
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Fatigue
|
30.8%
4/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Influenza like illness
|
23.1%
3/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Injection site inflammation
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Injection site pain
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Malaise
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Oedema peripheral
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Pyrexia
|
69.2%
9/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
100.0%
2/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Immune system disorders
Drug hypersensitivity
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Influenza
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Mastitis
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Nail infection
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Injury, poisoning and procedural complications
Heat cramps
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Investigations
Gamma-glutamyltransferase increased
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
4/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Nervous system disorders
Headache
|
38.5%
5/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Nervous system disorders
Neuralgia
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Nervous system disorders
Paraesthesia
|
15.4%
2/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Vascular disorders
Embolism
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Vascular disorders
Hot flush
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
General disorders
Disease progression
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
50.0%
1/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Investigations
General physical condition abnormal
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
0.00%
0/2 • Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Adverse events and serious adverse event are reported for all participants who received at least one dose of talimogene laherparepvec. Duration of treatment = ((The date of last dose of study drug - The date of first dose of study drug + 1)/365.25 \* 12).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER