Trial Outcomes & Findings for Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma (NCT NCT03064763)
NCT ID: NCT03064763
Last Updated: 2023-08-09
Results Overview
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 Events were considered DLTs, if judged by the investigator to be related to study treatment: Grade 4 non-hematologic toxicity Grade 3 non-hematologic toxicity lasting \> 3 days despite optimal supportive care (grade 3 fatigue not a DLT) Grade 3 or higher non-hematologic laboratory value reported as an adverse event if: medical intervention is required, or abnormality leads to hospitalization, or abnormality persists for \> 1 week (Laboratory values that persist for \> 1 week but are deemed not clinically important per both investigator and sponsor were not considered DLTs) Febrile neutropenia grade 3 or 4 Thrombocytopenia \< 25 x 10\^9/L associated with bleeding event requiring intervention Serious herpetic event (eg, herpetic encephalitis, encephalomyelitis, or disseminated herpetic infection) Grade 5 toxicity Any other intolerable toxicity leading to permanent discontinuation of study treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day 1 to Day 35
Results posted on
2023-08-09
Participant Flow
A total of 18 participants were enrolled at 8 centers in Japan from March 2017 until January 2023.
Participant milestones
| Measure |
Talimogene Laherparepvec
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Received Treatment
|
18
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Talimogene Laherparepvec
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Death
|
8
|
Baseline Characteristics
Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
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Age, Continuous
|
57.2 years
STANDARD_DEVIATION 18.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 35Population: The DLT Analysis Set: all participants who had the opportunity to be followed for at least 35 days on treatment from the initial dosing (unless discontinued due to DLT) and received at least 1 dose of talimogene laherparepvec.
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 Events were considered DLTs, if judged by the investigator to be related to study treatment: Grade 4 non-hematologic toxicity Grade 3 non-hematologic toxicity lasting \> 3 days despite optimal supportive care (grade 3 fatigue not a DLT) Grade 3 or higher non-hematologic laboratory value reported as an adverse event if: medical intervention is required, or abnormality leads to hospitalization, or abnormality persists for \> 1 week (Laboratory values that persist for \> 1 week but are deemed not clinically important per both investigator and sponsor were not considered DLTs) Febrile neutropenia grade 3 or 4 Thrombocytopenia \< 25 x 10\^9/L associated with bleeding event requiring intervention Serious herpetic event (eg, herpetic encephalitis, encephalomyelitis, or disseminated herpetic infection) Grade 5 toxicity Any other intolerable toxicity leading to permanent discontinuation of study treatment
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
|
Number of Participants Who Experienced One or More Dose Limiting Toxicities (DLTs)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to the maximum time on treatment or follow-up at primary data cutoff date (03 August 2020): 89.1 weeks of treatment and 37 months of follow-upPopulation: Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec.
DRR using WHO response criteria was defined as the percentage of participants who experienced objective response (complete response \[CR\] or partial response \[PR\]) lasting continuously for ≥ 6 months that starting any time within 12 months of initiating treatment. CR: Complete disappearance of all index lesions, including any new tumors which might have appeared. PR: Achieving a 50% or greater reduction in the SPD of the perpendicular diameters of all index lesions at the time of assessment as compared to the sum of the products of the perpendicular diameters of all index lesions at baseline (Day 1).
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
Durable Response Rate (DRR) Using Modified World Health Organization (WHO) Response Criteria
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
SECONDARY outcome
Timeframe: Day 1 to end of study, maximum time to end of study was 212.6 weeksPopulation: Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec.
ORR was defined as the percentage of participants who experienced an objective response of CR or PR per modified WHO response criteria among the set of participants analyzed.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
Overall Response Rate (ORR) Using Modified World Health Organization (WHO) Response Criteria
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
SECONDARY outcome
Timeframe: Day 1 to end of study, maximum time to end of study was 212.6 weeksPopulation: Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec.
TTR was defined as the time from the first treatment administration to the first incidence of a confirmed CR or PR according to modified WHO response criteria among the set of participants analyzed. TTR was estimated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
Time to Response (TTR) Using Modified World Health Organization (WHO) Response Criteria
|
NA Months
Interval 8.08 to
The median TTR or upper limit could not be estimated due to insufficient number of participants who experienced either CR or PR.
|
SECONDARY outcome
Timeframe: Day 1 to end of study, maximum time to end of study was 212.6 weeksPopulation: Responders among Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec who experienced a response of either CR or PR.
DOR was defined as the time from the date of an initial response (CR or PR) to the earlier of progressive disease (PD) or death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment. PD: A \> 25% increase in the sum of the products of the perpendicular diameters of all index tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point. DOR was estimated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=2 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
Duration of Response (DOR) Using Using Modified World Health Organization (WHO) Response Criteria
|
NA Months
Interval 11.07 to
The median DOR or upper limit could not be estimated due to insufficient number of participants who experienced either CR or PR.
|
SECONDARY outcome
Timeframe: Day 1 to end of study, maximum time to end of study was 212.6 weeksPopulation: Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec.
PFS was defined as the interval from the first dose to the earlier of PD per modified WHO response criteria or death from any cause; otherwise, PFS was censored at the last evaluable tumor assessment. PFS was estimated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
|
Progression Free Survival (PFS) Using Using Modified World Health Organization (WHO) Response Criteria
|
3.07 Months
Interval 2.56 to 5.78
|
SECONDARY outcome
Timeframe: Day 1 to end of study, maximum time to end of study was 212.6 weeksPopulation: Safety Analysis Set: all enrolled participants who received at least 1 dose of talimogene laherparepvec.
OS was defined as the interval from first dose to the event of death from any cause; otherwise, OS was censored at the date the participant was last known to be alive. OS was estimated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 17.51 to
The median OS or upper limit could not be estimated due to insufficient number of participants who experienced death.
|
Adverse Events
Talimogene Laherparepvec
Serious events: 6 serious events
Other events: 17 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Talimogene Laherparepvec
n=18 participants at risk
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
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|---|---|
|
General disorders
Malaise
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Enteritis infectious
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Epiglottitis
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Vascular disorders
Haemorrhage
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
Other adverse events
| Measure |
Talimogene Laherparepvec
n=18 participants at risk
Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.
On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10\^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10\^8 or 10\^7 PFU/mL. The second dose was administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were given every 2 weeks (+ 3 days). Participants could receive talimogene laherparepvec for a maximum treatment duration of 48 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Gastrointestinal disorders
Gingival pain
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Chills
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Fatigue
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Injection site reaction
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Malaise
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Pain
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
General disorders
Pyrexia
|
50.0%
9/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Bacterial infection
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Nasopharyngitis
|
27.8%
5/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Subcutaneous abscess
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
11.1%
2/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Immune system disorders
Contrast media allergy
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.6%
1/18 • Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks
|
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