Trial Outcomes & Findings for Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT NCT00865098)
NCT ID: NCT00865098
Last Updated: 2014-03-12
Results Overview
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks
Results posted on
2014-03-12
Participant Flow
Subjects were enrolled in this study at 4 centers in Japan. The first subject was enrolled on 06 March 2009 and the last on 04 January 2010.
27 subjects were enrolled and 5 were ineligible, not treated, and excluded from the Intention To Treat (ITT)/Safety Population. Reasons: investigator's decision (1 subject), withdrawal of consent (1 subject), inability to perform radiation therapy according to protocol (2 subjects) and inclusion/exclusion criteria not fulfilled (1 subject).
Participant milestones
| Measure |
Cetuximab With Radiotherapy
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
|
Overall Study
STARTED
|
22
|
Reasons for withdrawal
| Measure |
Cetuximab With Radiotherapy
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Overall Study
Progressive disease
|
1
|
Baseline Characteristics
Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 6.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeksPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Completion Rate
|
100 percentage of participants
Interval 84.6 to 100.0
|
SECONDARY outcome
Timeframe: best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was requiredPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (\>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Best Response Rate
|
81.8 percentage of participants
Interval 59.7 to 94.8
|
SECONDARY outcome
Timeframe: time from first dose up to 60 days after last dose of study treatment, ≤18 weeksPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Please refer to Adverse Events section for further details
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
22 participants
|
SECONDARY outcome
Timeframe: time from first dose up to 60 days after last dose of study treatment, ≤18 weeksPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Safety - Number of Patients Experiencing Any Grade 4 Adverse Event
|
2 participants
|
SECONDARY outcome
Timeframe: time from first dose up to 60 days after last dose of study treatment, ≤18 weeksPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction
|
3 participants
|
SECONDARY outcome
Timeframe: time from first dose up to 60 days after last dose of study treatment, ≤18 weeksPopulation: ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment
Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Outcome measures
| Measure |
Cetuximab With Radiotherapy
n=22 Participants
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction
|
0 participants
|
Adverse Events
Cetuximab With Radiotherapy
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab With Radiotherapy
n=22 participants at risk
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Nervous system disorders
Altered state of consciousness
|
4.5%
1/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
Other adverse events
| Measure |
Cetuximab With Radiotherapy
n=22 participants at risk
Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
31.8%
7/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Cheilitis
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Constipation
|
68.2%
15/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.5%
10/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Dry mouth
|
77.3%
17/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Dysphagia
|
40.9%
9/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
4/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Odynophagia
|
18.2%
4/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Stomatitis
|
27.3%
6/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
General disorders
Fatigue
|
18.2%
4/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
General disorders
Mucosal inflammation
|
86.4%
19/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
General disorders
Pyrexia
|
50.0%
11/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Infections and infestations
Infection
|
22.7%
5/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Infections and infestations
Paronychia
|
22.7%
5/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Infections and infestations
Pharyngitis
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
45.5%
10/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Blood albumin decreased
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Blood urea increased
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Investigations
Weight decreased
|
40.9%
9/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.5%
10/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
22.7%
5/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Nervous system disorders
Dysgeusia
|
68.2%
15/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Psychiatric disorders
Delirium
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Psychiatric disorders
Insomnia
|
22.7%
5/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
27.3%
6/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
4/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Acne
|
63.6%
14/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
50.0%
11/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
36.4%
8/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
68.2%
15/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
45.5%
10/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
13.6%
3/22 • Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.
Treatment emergent Adverse Events (TEAEs) were defined as AEs that emerge or worsen on or after the first dosing day of trial treatment until 60 days after the last trial treatment administration.
|
Additional Information
Masataka Ota
Merck Serono Co., Ltd, Tokyo, Japan
Phone: +81 0 3 6853 8611
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER