Trial Outcomes & Findings for Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma (NCT NCT00198133)
NCT ID: NCT00198133
Last Updated: 2019-07-22
Results Overview
The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2019-07-22
Participant Flow
This protocol was based on getting 27 evaluable patients through a two-stage design
Participant milestones
| Measure |
Thymoma
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
|
Overall Study
COMPLETED
|
11
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Thymoma
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Overall Study
Disease progression
|
2
|
5
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Baseline characteristics by cohort
| Measure |
Thymoma
n=16 Participants
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=11 Participants
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All patients with at least one post baseline measurement. (26 evaluable - 15 T and 11 TC patients)
The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
Outcome measures
| Measure |
Thymoma
n=15 Participants
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=11 Participants
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Objective Response Rate (Complete and Partial Response)
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
SECONDARY outcome
Timeframe: Time from the date of remission until progression or death, assessed up to 3 yearsPopulation: All patients with at least one post baseline measurement who had a response of CR or PR
Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
Outcome measures
| Measure |
Thymoma
n=4 Participants
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=1 Participants
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Duration of Remission
|
4.0 months
Interval 3.3 to 6.3
|
3.8 months
Since there was only one patient with an objective response, the confidence interval was not estimable.
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All patients enrolled and received treatment
To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).
Outcome measures
| Measure |
Thymoma
n=16 Participants
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=11 Participants
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Grade 3/4 Treatment Related Adverse Events
|
1 participants
|
1 participants
|
Adverse Events
Thymoma
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Thymic Carcinoma
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thymoma
n=16 participants at risk
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=11 participants at risk
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Cardiac disorders
SUPERIOR VENA CAVA SYNDROME (SVC)
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPNEA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
FATIGUE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
FEVER
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
BLOOD INFECTION (STAPHLOCOCCUS HOMINIS)
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
ACHALASIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
Other adverse events
| Measure |
Thymoma
n=16 participants at risk
Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
Thymic Carcinoma
n=11 participants at risk
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
|
|---|---|---|
|
Psychiatric disorders
IRRITIABLE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Psychiatric disorders
MOOD - DEPRESSION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
ANC (NEUTROPENIA)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
ANKLE EDEMA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
BILATERAL ANKLE EDEMA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
EDEMA +1
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
EDEMA - ANKLES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
EDEMA-LEFT ARM
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Blood and lymphatic system disorders
SWOLLEN FACE/RED
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Cardiac disorders
ARRHYTHIA (TACHYCARDIA)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Cardiac disorders
PERICARDIAL TAMPONADE
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Ear and labyrinth disorders
VERTIGO
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Endocrine disorders
DIABETES
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Endocrine disorders
HYPOTHYROID
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Eye disorders
BLURRY VISION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Eye disorders
DRY EYES
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Eye disorders
EYE DRAINAGE/ REDNESS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
ANOREXIA (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
BLOATING
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
CANDIDA ESOPHAGITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
54.5%
6/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DIARRHEA
|
31.2%
5/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DIARRHEA (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA (HEARTBURN)/REFLUX
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA (STOMACH ACHE)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPNEA
|
56.2%
9/16 • Beginning of treatment until the end of the study, up to 3 years
|
72.7%
8/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
DYSPNEA (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
GAS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
GERD
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
HEARTBURN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INCONTINENCE
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTEMITTENT DYSPEPSIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT CONSTIPATION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT DIARRHEA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT DYSPEPSIA
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT NAUSEA
|
18.8%
3/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT STOMACH PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
INTERMITTENT VOMITTING
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
MUCOSITIS
|
31.2%
5/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
MUCOSITIS (THRUSH)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
MUCOSITIS - ORAL CAVITY (MOUTH ULCERS)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
54.5%
6/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
NAUSEA (INTERMITTENT)
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
NAUSEA INTERMITTENT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
STOMATITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
TASTE ALTERATION
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Gastrointestinal disorders
VOMITING
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
36.4%
4/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
FATIGUE
|
75.0%
12/16 • Beginning of treatment until the end of the study, up to 3 years
|
90.9%
10/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
FEVER
|
18.8%
3/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INSOMNIA
|
50.0%
8/16 • Beginning of treatment until the end of the study, up to 3 years
|
45.5%
5/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INTERMITTENT ARTHRALGIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INTERMITTENT CHEST PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INTERMITTENT INSOMNIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INTERMITTENT MIGRAINES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
INTERMITTENT SORE THROAT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
JOINT PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
LEFT SHOULDER PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
LIMBIC ENCEPHALITIS (CHARACTERIZED BY DROWSINESS, HALLUCINATIONS, LOSS OF SHORT TERM MEMORY, CONFUSI
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
LT SHOULDER PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
MUSCULOSKELATAL CHEST PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
NIGHT SWEATS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PAIN (CHEST)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PAIN - RIGHT CHEST INCISIONAL
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PAIN - RIGHT LUNG
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PAIN - RIGHT SHOULDER
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PAIN - RIGHT UPPER CHEST
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
PANIC ATTACK INTERMITENT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
RIGHT HIP PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
RIGHT SHOULDER AND BACK PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
RIGHT-SIDED CHEST PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
RUNNING NOSE
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
RUNNY NOSE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
SHOULDER PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
SINUS CONGESTION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
SINUS DRAINAGE
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
SORE THROAT
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
General disorders
STOMACH PAIN
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
BRONCHITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
FLUSHING (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
FUNGAL INFECTION ON ANKLES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
INFECTION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
PHARGNGITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
SINUS INFECTIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
SINUS INFECTION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
SINUSITIS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
SINUSITIS (SINUS INFECTION)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
STAPH INFECTION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Infections and infestations
STREP INFLUENZA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
ELEVATED AST
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
ELEVATED LFT'S
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
ELEVATED LIVER ENZYMES
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
ELEVATED LIVER FUNC. TEST
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
ELEVATED LIVER FUNCTION TEST
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
HYPERBILIRUBINEMIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
HYPERBILRUBEMIA
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
HYPERGLYCEMIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Investigations
HYPERLIPIDEMIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
43.8%
7/16 • Beginning of treatment until the end of the study, up to 3 years
|
54.5%
6/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
ANKLE/KNEE PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIC PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN (INTERMITTENT FOR YEARS)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN (LEGS)
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
CHEST PAIN (MUSCULOSKELATAL)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
CHEST TIGHTNESS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
CYST ON LEFT BUTTOCK
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
GOUT
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK MIDDLE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - HANDS - INTERMITTAT BURNING SENSATION
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
HEADACHE
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
HEADACHES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
HEADACHES - INTERMITTENT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
INTERMITTENT TINGLING IN FINGERS AND TOES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
LEG WEAKNESS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY (FEET, TOES, & ELBOW NUMB)
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY (FINGERTIPS)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY - FINGERS
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY - FINGERS AND TOES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY - HANDS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY - TOES
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY, SENSORY: TOES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NEUROPATHY-SENSORY- BALL OF FEET
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NUMBNESS - FEET
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NUMBNESS - LEFT CHEST INCISIONAL
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
NUMBNESS OF BOTH LEGS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
RIGHT FOOT TREMOR
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
RIGHT HAND TREMOR
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Nervous system disorders
SENSORY NEUROPATHY - BOTTOM OF FEET NUMB
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Psychiatric disorders
ANXIETY
|
31.2%
5/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Psychiatric disorders
ANXIETY (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Renal and urinary disorders
NOCTURIA
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Renal and urinary disorders
PAIN - KIDNEY AREA LEFT AND RIGHT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Renal and urinary disorders
POLYURIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA (BRONCHIOSPASM)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ATCLECTASIS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
8/16 • Beginning of treatment until the end of the study, up to 3 years
|
54.5%
6/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
27.3%
3/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
INTERMITTENT HICCUPS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA - THINNING
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BILATERALLY
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
HIVES
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION OF PALMS OF HANDS
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITIUS/ITCHING
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
25.0%
4/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
18.8%
3/16 • Beginning of treatment until the end of the study, up to 3 years
|
18.2%
2/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING (INTERMITTENT)
|
12.5%
2/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
37.5%
6/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH (INFUSION SITE)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH (INTERMITTENT)
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH (LEFT CHEST)
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH (NECK) INTERMITTENT
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH - NECK AND ABDOMEN AREA
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH - RED FACE AND ARMS
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN - RED, RAISED RASH ON NECK AND UPPER CHEST
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
SURGERY (REMOVAL SKIN CANCER) FACE & RIGHT ARM
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
UPPER CHEST ITCHING
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Vascular disorders
BLOOD CLOT-LEFT ARM
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/16 • Beginning of treatment until the end of the study, up to 3 years
|
9.1%
1/11 • Beginning of treatment until the end of the study, up to 3 years
|
|
Vascular disorders
INTERMITTENT BLOODY NOSE
|
6.2%
1/16 • Beginning of treatment until the end of the study, up to 3 years
|
0.00%
0/11 • Beginning of treatment until the end of the study, up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place