Trial Outcomes & Findings for A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer (NCT NCT00412217)
NCT ID: NCT00412217
Last Updated: 2016-11-25
Results Overview
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
From inclusion in the study until disease progression (maximum up to 3 years overall)
Results posted on
2016-11-25
Participant Flow
Participant milestones
| Measure |
Erlotinib
Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
48
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
46
|
48
|
Reasons for withdrawal
| Measure |
Erlotinib
Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Overall Study
Insufficient Data Available
|
8
|
3
|
|
Overall Study
Death
|
5
|
4
|
|
Overall Study
Disease Progression
|
2
|
3
|
|
Overall Study
Investigator Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
26
|
33
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib
n=46 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 Years or Older
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From inclusion in the study until disease progression (maximum up to 3 years overall)Population: ITT Population.
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.
Outcome measures
| Measure |
Erlotinib
n=46 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Number of Participants With Disease Progression
|
15 participants
|
11 participants
|
PRIMARY outcome
Timeframe: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)Population: ITT Population.
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
Outcome measures
| Measure |
Erlotinib
n=46 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Time to Progression (TTP)
|
NA months
Interval 13.6259 to
The median and upper limit of the 95% CI for PFS were not reached during the study period and could not be calculated.
|
NA months
Interval 18.411 to
The median and upper limit of the 95% CI for PFS were not reached during the study period and could not be calculated.
|
SECONDARY outcome
Timeframe: From inclusion in the study until death from any cause (maximum up to 3 years overall)Population: ITT Population.
The number of participants who died from any cause was reported.
Outcome measures
| Measure |
Erlotinib
n=46 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Number of Participants Who Died
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From inclusion in the study until death from any cause (maximum up to 3 years overall)Population: ITT Population.
OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.
Outcome measures
| Measure |
Erlotinib
n=46 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 Participants
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
The lower limit of the 95% CI for OS was not reached during the study period and therefore no values could be calculated.
|
NA months
The lower limit of the 95% CI for OS was not reached during the study period and therefore no values could be calculated.
|
Adverse Events
Erlotinib
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=46 participants at risk
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 participants at risk
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
2.1%
1/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Surgical and medical procedures
Dental extraction
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Vascular disorders
Aneurism
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Resection of right cervical tumor
|
0.00%
0/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
2.1%
1/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
Other adverse events
| Measure |
Erlotinib
n=46 participants at risk
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
|
Placebo
n=48 participants at risk
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
8.3%
4/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Ear and labyrinth disorders
Acufenos
|
4.3%
2/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
6.2%
3/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Ear and labyrinth disorders
Earache
|
8.7%
4/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
4.2%
2/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Dry mouth
|
26.1%
12/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
37.5%
18/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
12/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Dysphagia
|
13.0%
6/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
14.6%
7/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Dyspesia
|
6.5%
3/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
4.2%
2/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Stomatitus
|
4.3%
2/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
6.2%
3/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Gastrointestinal disorders
Odynophagia
|
2.2%
1/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
18.8%
9/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
General disorders
Asthenia
|
32.6%
15/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
22.9%
11/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
General disorders
Edema
|
6.5%
3/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
10.4%
5/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
General disorders
Localized edema
|
8.7%
4/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
8.3%
4/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
General disorders
Mucosa inflammation
|
15.2%
7/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
10.4%
5/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
General disorders
Pyrexia
|
10.9%
5/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Infections and infestations
Folliculitis
|
15.2%
7/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
2.1%
1/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.9%
5/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
14.6%
7/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
4/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
8.3%
4/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.9%
5/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
10.4%
5/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.9%
5/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
6.2%
3/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal rigidity
|
6.5%
3/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
6.2%
3/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
8.3%
4/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
4/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
10.4%
5/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.0%
6/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
15.2%
7/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
2.1%
1/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
8/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
2.1%
1/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
10.9%
5/46 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
0.00%
0/48 • From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER