Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy (NCT NCT02013206)
NCT ID: NCT02013206
Last Updated: 2014-12-19
Results Overview
Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
COMPLETED
PHASE2
52 participants
Week 8
2014-12-19
Participant Flow
Participant milestones
| Measure |
Current/Former Smokers
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
23
|
|
Overall Study
Received Study Drug
|
26
|
23
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
27
|
22
|
Reasons for withdrawal
| Measure |
Current/Former Smokers
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Progressive disease (PD)
|
14
|
17
|
|
Overall Study
Symptomatic deterioration
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Patient refusal
|
2
|
0
|
|
Overall Study
Patient non-compliance
|
1
|
0
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Other reasons off treatment
|
5
|
2
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
Baseline characteristics by cohort
| Measure |
Current/Former Smokers
n=29 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
66 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Intent-to-Treat Population included all registered participants.
Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Current/Former Smokers
n=29 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Non-Progression Rate (NPR) at 8 Weeks
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
65.2 percentage of participants
Interval 42.7 to 83.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Intent-to-Treat Population included all registered participants.
Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
Outcome measures
| Measure |
Current/Former Smokers
n=29 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate
|
17 percentage of participants
Interval 5.9 to 35.8
|
35 percentage of participants
Interval 16.4 to 57.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Intent-to-Treat Population included all registered participants.
Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
Outcome measures
| Measure |
Current/Former Smokers
n=29 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease Control Rate
|
41 percentage of participants
Interval 23.5 to 61.1
|
65 percentage of participants
Interval 42.7 to 83.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants from the Intent-to-Treat (ITT) Population, that included all participants, with CR or PR. Patients still responding to treatment at the time of analysis were treated as censored observations for duration of response on the date of the last tumour assessment.
Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Current/Former Smokers
n=5 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=8 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response
|
13.1 months
Interval 4.6 to 13.1
|
5.7 months
Interval 4.0 to
95% Confidence Interval Upper limit was not estimated due to the small number of participants.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population included all registered patients who received at least 1 dose of study treatment and had at least 1 safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.
Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Current/Former Smokers
n=26 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Progression
|
1.9 months
Interval 1.0 to 5.6
|
5.5 months
Interval 3.4 to 7.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population included all registered participants who received at least one study treatment and had at least one safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.
Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.
Outcome measures
| Measure |
Current/Former Smokers
n=26 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival
|
1.9 months
Interval 1.0 to 5.6
|
4.1 months
Interval 3.4 to 5.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population included all participants with at least one study treatment and had at least one safety follow-up. Patients who had not died at the time of the final analysis were censored at the date of last contact.
Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.
Outcome measures
| Measure |
Current/Former Smokers
n=26 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
9.9 months
Interval 5.6 to 14.0
|
13.9 months
Interval 8.9 to 18.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population included all registered participant who received at least one study treatment and had at least one safety follow-up.
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Outcome measures
| Measure |
Current/Former Smokers
n=26 Participants
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 Participants
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse Events
|
26 participants
|
23 participants
|
|
Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Serious Adverse Events
|
14 participants
|
7 participants
|
Adverse Events
Current/Former Smokers
Never Smokers
Serious adverse events
| Measure |
Current/Former Smokers
n=26 participants at risk
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 participants at risk
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
General disorders
Performance status decreased
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Infections and infestations
Pseudomonas infection
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Nervous system disorders
Cerebral ischaemia
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Nervous system disorders
Transient ischaemic attack
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Renal and urinary disorders
Anuria
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Reproductive system and breast disorders
Ovarian disorder
|
3.8%
1/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Infections and infestations
Abscess
|
0.00%
0/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Investigations
Biopsy muscle
|
0.00%
0/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
Other adverse events
| Measure |
Current/Former Smokers
n=26 participants at risk
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
|
Never Smokers
n=23 participants at risk
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
4/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Cardiac disorders
Tachycardia
|
7.7%
2/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Eye disorders
Conjunctivitis
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Eye disorders
Dry Eye
|
7.7%
2/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Eye disorders
Growth of eyelashes
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
6/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.5%
3/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
53.8%
14/26 • Up to 2 Years
|
47.8%
11/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
4/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Up to 2 Years
|
47.8%
11/23 • Up to 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Up to 2 Years
|
17.4%
4/23 • Up to 2 Years
|
|
General disorders
Asthenia
|
30.8%
8/26 • Up to 2 Years
|
34.8%
8/23 • Up to 2 Years
|
|
General disorders
Chest pain
|
19.2%
5/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
General disorders
Fatigue
|
15.4%
4/26 • Up to 2 Years
|
17.4%
4/23 • Up to 2 Years
|
|
General disorders
Mucosal inflammation
|
11.5%
3/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
General disorders
Oedema
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
General disorders
Pyrexia
|
26.9%
7/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
General disorders
Xerosis
|
7.7%
2/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Infections and infestations
Paronychia
|
7.7%
2/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Infections and infestations
Respiratory tract infection
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complication
|
3.8%
1/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Investigations
Weight decreased
|
30.8%
8/26 • Up to 2 Years
|
30.4%
7/23 • Up to 2 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
8/26 • Up to 2 Years
|
52.2%
12/23 • Up to 2 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
4/26 • Up to 2 Years
|
17.4%
4/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
1/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
2/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Nervous system disorders
Dysgeusia
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Psychiatric disorders
Anxiety
|
7.7%
2/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
11.5%
3/26 • Up to 2 Years
|
13.0%
3/23 • Up to 2 Years
|
|
Renal and urinary disorders
Dysuria
|
11.5%
3/26 • Up to 2 Years
|
0.00%
0/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Up to 2 Years
|
30.4%
7/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
8/26 • Up to 2 Years
|
21.7%
5/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
5/26 • Up to 2 Years
|
34.8%
8/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.1%
6/26 • Up to 2 Years
|
17.4%
4/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
5/26 • Up to 2 Years
|
17.4%
4/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
73.1%
19/26 • Up to 2 Years
|
82.6%
19/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
11.5%
3/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Congenital, familial and genetic disorders
Trichomegaly
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Eye disorders
Blepharitis
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
General disorders
Mucosal dryness
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Investigations
Blood bilirubin increased
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Nervous system disorders
Lethargy
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/26 • Up to 2 Years
|
8.7%
2/23 • Up to 2 Years
|
|
Infections and infestations
Subcutaneous abscess
|
3.8%
1/26 • Up to 2 Years
|
4.3%
1/23 • Up to 2 Years
|
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