Trial Outcomes & Findings for A Rollover Protocol of Dacomitinib For Patients In Japan (NCT NCT02382796)
NCT ID: NCT02382796
Last Updated: 2020-07-02
Results Overview
To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
4 years
Results posted on
2020-07-02
Participant Flow
It is a multi-center,treatment extension study open in Japan only.Eligible participants were those with advanced non-small cell lung cancer who received and tolerated dacomitinib in studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and had the potential to derive continued clinical benefit based on investigator judgment.
Participant milestones
| Measure |
Dacomitinib
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Dacomitinib
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Overall Study
Global deterioration of health status
|
1
|
|
Overall Study
Objective progression or relapse
|
3
|
|
Overall Study
Commercial dacomitinib became available
|
3
|
Baseline Characteristics
A Rollover Protocol of Dacomitinib For Patients In Japan
Baseline characteristics by cohort
| Measure |
Dacomitinib
n=7 Participants
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese) · 7
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: All participants who received any study medication.
To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.
Outcome measures
| Measure |
Dacomitinib
n=7 Participants
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study
7
|
7 Participants
|
SECONDARY outcome
Timeframe: Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeksPopulation: All participants who received any study medication.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.
Outcome measures
| Measure |
Dacomitinib
n=7 Participants
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs · 7
|
7 Participants
|
|
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs · 7
|
2 Participants
|
Adverse Events
Dacomitinib
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dacomitinib
n=7 participants at risk
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Dacomitinib
n=7 participants at risk
Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Blepharitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Corneal erosion
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Posterior capsule opacification
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Swelling of eyelid
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Face oedema
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung infection
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Paronychia
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pleural infection
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
28.6%
2/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
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