Trial Outcomes & Findings for Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer (NCT NCT02499120)
NCT ID: NCT02499120
Last Updated: 2023-09-08
Results Overview
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Baseline up to primary completion date (PCD) (about 34 months)
Results posted on
2023-09-08
Participant Flow
A total of 125 participants were randomized; among them, 124 participants received study treatments. One (1) participant in the palbociclib + cetuximab treatment group was randomized but not treated.
Participant milestones
| Measure |
Palbociclib + Cetuximab
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
60
|
|
Overall Study
Received Treatment
|
64
|
60
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
65
|
60
|
Reasons for withdrawal
| Measure |
Palbociclib + Cetuximab
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Overall Study
Death
|
52
|
43
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Participant refused further follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Other
|
9
|
10
|
Baseline Characteristics
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Baseline characteristics by cohort
| Measure |
Palbociclib + Cetuximab
n=65 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to primary completion date (PCD) (about 34 months)Population: The analysis population was intent-to-treat (ITT) population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=65 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Overall Survival (OS)
|
9.7 months
Interval 7.3 to 13.9
|
7.8 months
Interval 6.7 to 10.6
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: The analysis population was intent-to-treat (ITT) population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
PFS was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever was earlier. Estimates of the PFS curves from the Kaplan Meier method were presented.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=65 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.9 months
Interval 3.6 to 5.6
|
4.6 months
Interval 2.3 to 5.5
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: The analysis population was ITT population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
OR was defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate was defined as the proportion of participants with best overall response (BOR) of CR or PR relative to all randomized.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=65 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR)
|
27.7 Percentage of participants
Interval 17.3 to 40.2
|
25.0 Percentage of participants
Interval 14.7 to 37.9
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: The analysis population was ITT population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
CBR was defined as the overall CR, PR, or stable disease\>=24 weeks according to the RECIST version 1.1. Clinical benefit response rate was defined as the proportion of participants with CR, PR, or stable disease\>= 24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=65 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit Response (CBR)
|
36.9 Percentage of participants
Interval 25.3 to 49.8
|
36.7 Percentage of participants
Interval 24.6 to 50.1
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: DR was only calculated for the subgroup of all ITT participants with an objective tumor response.
DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the date response ended (ie, date of PD or death) - first CR or PR date + 1\]/30.4.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=18 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=15 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Duration of Response (DR)
|
7.6 months
Interval 3.7 to 7.7
|
7.4 months
Interval 3.6 to
Number of participants with confirmed objective response was too small to provide such summary statistics (upper limit of 95% CI).
|
SECONDARY outcome
Timeframe: From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)Population: The analysis population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. TEAEs were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=64 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
Grade 5 AEs (all causality)
|
15 Participants
|
11 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
Grade 3 or 4 AEs (treatment-related)
|
34 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
Grade 5 AEs (treatment-related)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
AEs (all causality)
|
61 Participants
|
56 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
AEs (treatment-related)
|
58 Participants
|
48 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
SAEs (all causality)
|
25 Participants
|
19 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
SAEs (treatment-related)
|
7 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
Grade 3 or 4 AEs (all causality)
|
33 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From the Screening (Day -28) through and including 28 calendar days after the last administration of the study treatment (up to 7 years)Population: The analysis population included all participants with at least 1 observation of the laboratory test while on study treatment or during lag time.
The hematology, chemistry and coagulation tests were included in the laboratory examination. Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes. Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate and hemoglobin A1c (HbA1c). Coagulation evaluation included activated partial thromboplastin time/partial thromboplastin time, international normalized ratio (INR) or prothrombin time.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=62 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=59 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
61 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: The analysis population included all ITT participants, who had both baseline and at least 1 follow-up patient reported outcome (PRO) assessment before treatment discontinuation.
The EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=57 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=55 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Functional scale: Physical functioning
|
0.74 units on a scale
Interval -3.26 to 4.73
|
-0.46 units on a scale
Interval -4.59 to 3.66
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Functional scale: Social functioning
|
1.24 units on a scale
Interval -4.43 to 6.9
|
2.08 units on a scale
Interval -3.76 to 7.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Nausea and vomiting
|
-0.87 units on a scale
Interval -2.63 to 0.9
|
-1.04 units on a scale
Interval -2.82 to 0.74
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Pain
|
-5.98 units on a scale
Interval -11.06 to -0.9
|
-6.10 units on a scale
Interval -11.32 to -0.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status / QOL
|
2.82 units on a scale
Interval -1.49 to 7.13
|
2.69 units on a scale
Interval -1.7 to 7.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Functional scale: Role functioning
|
-0.41 units on a scale
Interval -5.91 to 5.09
|
-1.60 units on a scale
Interval -7.28 to 4.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Functional scale: Emotional functioning
|
4.16 units on a scale
Interval 0.13 to 8.18
|
3.56 units on a scale
Interval -0.57 to 7.69
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Functional scale: Cognitive functioning
|
-1.47 units on a scale
Interval -5.14 to 2.21
|
-1.23 units on a scale
Interval -5.06 to 2.59
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Fatigue
|
-2.79 units on a scale
Interval -7.04 to 1.46
|
-5.12 units on a scale
Interval -9.5 to -0.75
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Dyspnoea
|
3.07 units on a scale
Interval -2.15 to 8.3
|
5.09 units on a scale
Interval -0.27 to 10.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Insomnia
|
-4.62 units on a scale
Interval -10.33 to 1.08
|
-5.02 units on a scale
Interval -10.88 to 0.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Appetite loss
|
2.25 units on a scale
Interval -3.89 to 8.38
|
-0.69 units on a scale
Interval -7.04 to 5.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Constipation
|
-4.12 units on a scale
Interval -10.3 to 2.06
|
-1.33 units on a scale
Interval -7.72 to 5.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Diarrhoea
|
4.26 units on a scale
Interval 1.34 to 7.17
|
1.74 units on a scale
Interval -1.24 to 4.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Symptom scale/item: Financial difficulties
|
-5.26 units on a scale
Interval -11.61 to 1.1
|
-0.27 units on a scale
Interval -6.83 to 6.29
|
SECONDARY outcome
Timeframe: Baseline up to PCD (about 34 months)Population: The analysis population included all ITT participants, who had both baseline and at least 1 follow-up PRO assessment before treatment discontinuation.
The EORTC QLQ-H\&N35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much"). Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms.Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=57 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=55 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Swallowing
|
-4.34 units on a scale
Interval -8.79 to 0.1
|
-1.47 units on a scale
Interval -6.03 to 3.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Teeth
|
-1.59 units on a scale
Interval -8.91 to 5.74
|
-1.88 units on a scale
Interval -9.29 to 5.53
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Nutritional supplements
|
0.351 units on a scale
Interval -7.19 to 7.89
|
-4.37 units on a scale
Interval -12.23 to 3.49
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Pain
|
-3.57 units on a scale
Interval -8.56 to 1.43
|
-0.41 units on a scale
Interval -5.54 to 4.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Senses problems
|
-1.58 units on a scale
Interval -7.22 to 4.05
|
-1.88 units on a scale
Interval -7.72 to 3.96
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Speech problems
|
-4.54 units on a scale
Interval -9.21 to 0.13
|
-2.69 units on a scale
Interval -7.51 to 2.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Trouble with social eating
|
-5.55 units on a scale
Interval -10.14 to -0.96
|
-0.71 units on a scale
Interval -5.42 to 4.01
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Trouble with social contact
|
-1.27 units on a scale
Interval -5.68 to 3.15
|
3.45 units on a scale
Interval -1.14 to 8.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Less sexuality
|
-3.32 units on a scale
Interval -11.44 to 4.8
|
4.90 units on a scale
Interval -3.72 to 13.53
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Opening mouth
|
0.35 units on a scale
Interval -5.29 to 5.99
|
0.22 units on a scale
Interval -5.56 to 5.99
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Dry mouth
|
-6.30 units on a scale
Interval -10.5 to -2.1
|
3.44 units on a scale
Interval -0.82 to 7.71
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Sticky saliva
|
-3.91 units on a scale
Interval -9.7 to 1.88
|
4.68 units on a scale
Interval -1.22 to 10.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Coughing
|
-3.99 units on a scale
Interval -8.67 to 0.69
|
-1.72 units on a scale
Interval -6.48 to 3.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Felt ill
|
1.320 units on a scale
Interval -4.22 to 6.86
|
0.12 units on a scale
Interval -5.45 to 5.7
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Pain killers
|
-13.18 units on a scale
Interval -24.49 to -1.88
|
-11.39 units on a scale
Interval -23.02 to 0.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Feeding tube
|
-6.36 units on a scale
Interval -9.58 to -3.15
|
-0.11 units on a scale
Interval -3.3 to 3.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Weight loss
|
-17.72 units on a scale
Interval -27.23 to -8.21
|
-9.47 units on a scale
Interval -19.16 to 0.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Symptom scale/item: Weight gain
|
-3.03 units on a scale
Interval -10.08 to 4.02
|
5.16 units on a scale
Interval -1.96 to 12.27
|
SECONDARY outcome
Timeframe: ScreeningPopulation: The analysis population included all participants treated with cetuximab in combination with placebo or palbociclib who had at least 1 baseline biomarker assessment.
A central test was defined as the tumor tissue-based p16 IHC test performed at a central laboratory (Ventana). The analysis of concordance between HPV status as assessed by local or central laboratory included the number and percentage of participants with p16 detected or not detected at the central laboratory, given that all local testing must have been negative for HPV in order for the patient to be eligible for the study. Initial analysis of the p16 status was based on the conventional cutoff of 70% p16-positive tumor cells to call out cases that might be considered HPV-positive. P16 expression was scored as positive if strong and diffuse nuclear and cytoplasmic staining was present in at least 70% of the tumor cells.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=54 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=48 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%)
PFS
|
3.7 months
Interval 3.2 to 5.6
|
5.0 months
Interval 3.3 to 7.2
|
|
Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%)
OS
|
9.9 months
Interval 7.1 to 13.9
|
8.0 months
Interval 7.0 to 14.7
|
SECONDARY outcome
Timeframe: ScreeningPopulation: The analysis population included all participants treated with cetuximab in combination with placebo or palbociclib who had at least 1 baseline biomarker assessment.
Rb expression in the palbociclib and cetuximab treatment group, the relationship of the biomarker (individually) with PFS and OS were explored using graphical methods such as box plots, at baseline. The tumors of participants were Rb-positive, which was defined by Rb IHC with\>=1% positive tumor cells.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=57 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=53 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1%
PFS
|
3.9 months
Interval 3.5 to 6.2
|
4.6 months
Interval 2.6 to 5.6
|
|
Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1%
OS
|
10.5 months
Interval 7.1 to 15.6
|
7.8 months
Interval 6.9 to 11.8
|
SECONDARY outcome
Timeframe: Pre-dose of Day 15 in Cycle 1 and Cycle 2Population: The analysis population included all as-treated participants, who were treated with the study treatments and had at least measured plasma concentration for at least 1 analyte (palbociclib and/or cetuximab)
Ctrough is steady-state pre-dose concentration, which was observed directly from data. WPM-Ctrough is within-participant mean steady-state pre-dose concentration. For palbociclib, a steady-state trough was to be defined as a pre-dose plasma concentration following at least 7 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 24 hr +/- 2 hr and 24 min post-dose the day prior to PK collection and no more than 1 hr post-dose on the day of PK collection.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=57 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib
Ctrough Cycle 2 Day 15
|
67.8 nanograms per milliliter (ng/ml)
Standard Deviation 28.905
|
—
|
|
Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib
Ctrough Cycle 1 Day 15
|
69.8 nanograms per milliliter (ng/ml)
Standard Deviation 28.208
|
—
|
|
Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib
WPM-Ctrough
|
71.6 nanograms per milliliter (ng/ml)
Standard Deviation 30.183
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and end-of infusion of Day 15 in Cycle 1 and Cycle 2Population: The analysis population included all as-treated participants, who were treated with the study treatments and had at least measured plasma concentration for at least 1 analyte (palbociclib and/or cetuximab)
Ctrough is steady-state pre-dose concentration. Cendinf is steady-state end-of-infusion concentration. Ctrough and Cendinf were observed directly from data. WPM-Ctrough and WPM-Cendinf are within-participant mean steady-state pre-dose concentration and end-of-infusion concentration. Acceptance criteria for a steady-state Cendinf was defined as a PK sample that was 1) collected after at least 3 consecutive weeks of cetuximab IV infusions without interruption or prior dose reduction and 2) was collected at the end of cetuximab infusion time +/- 10% of the actual duration of the cetuximab infusion.
Outcome measures
| Measure |
Palbociclib + Cetuximab
n=57 Participants
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=57 Participants
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Ctrough Cycle 1 Day 15
|
39706.4 ng/ml
Geometric Coefficient of Variation 92
|
42914.1 ng/ml
Geometric Coefficient of Variation 62
|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
WPM-Ctrough
|
45605.9 ng/ml
Geometric Coefficient of Variation 83
|
46796.5 ng/ml
Geometric Coefficient of Variation 63
|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Cendinf Cycle 1 Day 15
|
145748.3 ng/ml
Geometric Coefficient of Variation 43
|
137185.5 ng/ml
Geometric Coefficient of Variation 61
|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Cendinf Cycle 2 Day 15
|
149155.7 ng/ml
Geometric Coefficient of Variation 38
|
153310.1 ng/ml
Geometric Coefficient of Variation 39
|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Ctrough Cycle 2 Day 15
|
51005.3 ng/ml
Geometric Coefficient of Variation 74
|
52995.7 ng/ml
Geometric Coefficient of Variation 71
|
|
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
WPM-Cendinf
|
149119.2 ng/ml
Geometric Coefficient of Variation 36
|
148063.3 ng/ml
Geometric Coefficient of Variation 39
|
Adverse Events
Palbociclib + Cetuximab
Serious events: 25 serious events
Other events: 55 other events
Deaths: 52 deaths
Placebo + Cetuximab
Serious events: 19 serious events
Other events: 53 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Palbociclib + Cetuximab
n=64 participants at risk
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 participants at risk
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
2/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Death
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Disease progression
|
10.9%
7/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
6/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
General physical health deterioration
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Abscess
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Lung abscess
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.3%
2/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Coma
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Seizure
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.3%
2/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Palbociclib + Cetuximab
n=64 participants at risk
Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
Placebo + Cetuximab
n=60 participants at risk
Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m\^2 initial dose as a 120-minute IV infusion followed by 250 mg/m\^2 weekly infused over 60 minutes.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
21.9%
14/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
21.7%
13/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.1%
9/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.3%
2/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.9%
7/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.2%
27/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
35.0%
21/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypertension
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.3%
2/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypotension
|
4.7%
3/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Asthenia
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.7%
7/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
12.5%
8/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pyrexia
|
14.1%
9/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.9%
23/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.3%
13/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.9%
7/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.7%
19/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
10.9%
7/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.1%
9/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
14.1%
9/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
8/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
6/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Paronychia
|
3.1%
2/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
6/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
2/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood creatinine increased
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
3/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Neutrophil count decreased
|
14.1%
9/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Platelet count decreased
|
15.6%
10/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Weight decreased
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
3/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
White blood cell count decreased
|
17.2%
11/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
12/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
10/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
3/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.4%
6/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.4%
6/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
1.7%
1/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.2%
11/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.8%
5/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
4.7%
3/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
6/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
3/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
5/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
4/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
13.3%
8/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.4%
6/64 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.7%
4/60 • From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER