Trial Outcomes & Findings for Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer (NCT NCT04533451)
NCT ID: NCT04533451
Last Updated: 2025-06-13
Results Overview
Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
Up to 7 days of last day of treatment, up to 6 months
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
Group A (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\>\> \>\> Pembrolizumab: Given IV\>\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>\>
\>\> Questionnaire Administration: Ancillary studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\>\> \>\> Pembrolizumab: Given IV\>\>
\>\> Pemetrexed: Given IV\>\>
\>\> Carboplatin: Given IV\>\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>\>
\>\> Questionnaire Administration: Ancillary studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
56
|
|
Overall Study
COMPLETED
|
43
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Group A (Pembrolizumab)
n=45 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\>\> \>\> Pembrolizumab: Given IV\>\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>\>
\>\> Questionnaire Administration: Ancillary studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
n=56 Participants
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\>\> \>\> Pembrolizumab: Given IV\>\>
\>\> Pemetrexed: Given IV\>\>
\>\> Carboplatin: Given IV\>\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>\>
\>\> Questionnaire Administration: Ancillary studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.0 years
STANDARD_DEVIATION 5.85 • n=93 Participants
|
76.1 years
STANDARD_DEVIATION 4.21 • n=4 Participants
|
77.8 years
STANDARD_DEVIATION 5.35 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
ECOG Performance Status
0
|
11 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
ECOG Performance Status
1
|
25 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
ECOG Performance Status
2
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
ECOG Performance Status
3
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Concomitant Chemo
No
|
45 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Concomitant Chemo
Yes
|
0 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Prior Adjuvant Chemo
No
|
40 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Prior Adjuvant Chemo
Yes
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Prior Radiotherapy
No
|
34 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Prior Radiotherapy
Yes
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Any Prior Cancer Diagnosed
No
|
34 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Any Prior Cancer Diagnosed
Yes
|
11 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Cancer Treatment started prior to enrollment
No
|
39 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Cancer Treatment started prior to enrollment
Yes
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Smoking History
No
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Smoking History
Yes
|
42 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
|
PD-L1 Expression
|
54.1 Tumor Proportion Score (%)
STANDARD_DEVIATION 37.35 • n=93 Participants
|
13.6 Tumor Proportion Score (%)
STANDARD_DEVIATION 25.84 • n=4 Participants
|
32.1 Tumor Proportion Score (%)
STANDARD_DEVIATION 37.43 • n=27 Participants
|
|
Diagnosis of Non-Small Cell Lung Cancer
Recurrent Metastatic
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Diagnosis of Non-Small Cell Lung Cancer
Stage IV
|
39 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days of last day of treatment, up to 6 monthsAssessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.
Outcome measures
| Measure |
Group A (Pembrolizumab)
n=43 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pemetrexed: Given IV\>
\>\>
\>
\>\> Carboplatin: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Grade 3 or Worse Adverse Events Post Registration
|
11 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From study registration to death or the last follow-up whichever occurs first, assessed up to 3 yearsWill be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.
Outcome measures
| Measure |
Group A (Pembrolizumab)
n=43 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pemetrexed: Given IV\>
\>\>
\>
\>\> Carboplatin: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Survival (OS)
|
16.4 months
Interval 10.1 to
Not enough events after median
|
29.9 months
Interval 16.4 to
Not enough events after median
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: There were 60 patients who had QOL change from baseline to week 9. Per the protocol section 13.5, quality of life would be examined combined by arm.
The overall quality of life score (the first question of the Linear Analogue Self-Assessment \[LASA\] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better.
Outcome measures
| Measure |
Group A (Pembrolizumab)
n=60 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pemetrexed: Given IV\>
\>\>
\>
\>\> Carboplatin: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire
|
0.0 score on a scale
Interval -1.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.Population: Analyzed with both arms combined
The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.
Outcome measures
| Measure |
Group A (Pembrolizumab)
n=95 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pemetrexed: Given IV\>
\>\>
\>
\>\> Carboplatin: Given IV\>
\>\>
\>
\>\> Comprehensive Geriatric Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Comprehensive Geriatric Assessment Risk Score
High Risk Group
|
4 Participants
|
—
|
|
Comprehensive Geriatric Assessment Risk Score
Low Risk Group
|
14 Participants
|
—
|
|
Comprehensive Geriatric Assessment Risk Score
Medium Risk Group
|
15 Participants
|
—
|
Adverse Events
Group A (Pembrolizumab)
Serious events: 8 serious events
Other events: 43 other events
Deaths: 8 deaths
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
Serious events: 6 serious events
Other events: 53 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Group A (Pembrolizumab)
n=43 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
n=54 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Cardiac disorders
Heart failure
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
General disorders
Death NOS
|
11.6%
5/43 • Number of events 5 • Up to 3 years
|
9.3%
5/54 • Number of events 5 • Up to 3 years
|
|
General disorders
Disease progression
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Group A (Pembrolizumab)
n=43 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group B (Pembrolizumab, Pemetrexed, Carboplatin)
n=54 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
53.5%
23/43 • Number of events 173 • Up to 3 years
|
85.2%
46/54 • Number of events 338 • Up to 3 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.3%
1/43 • Number of events 17 • Up to 3 years
|
1.9%
1/54 • Number of events 39 • Up to 3 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.7%
2/43 • Number of events 3 • Up to 3 years
|
3.7%
2/54 • Number of events 13 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43 • Up to 3 years
|
7.4%
4/54 • Number of events 4 • Up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/43 • Number of events 3 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 12 • Up to 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.7%
2/43 • Number of events 31 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.3%
1/43 • Number of events 12 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
5.6%
3/54 • Number of events 8 • Up to 3 years
|
|
Endocrine disorders
Hypophysitis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
16.3%
7/43 • Number of events 87 • Up to 3 years
|
27.8%
15/54 • Number of events 71 • Up to 3 years
|
|
Eye disorders
Blurred vision
|
11.6%
5/43 • Number of events 24 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Cataract
|
2.3%
1/43 • Number of events 14 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Eye disorders
Dry eye
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Flashing lights
|
2.3%
1/43 • Number of events 6 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.6%
11/43 • Number of events 22 • Up to 3 years
|
24.1%
13/54 • Number of events 23 • Up to 3 years
|
|
Gastrointestinal disorders
Belching
|
2.3%
1/43 • Number of events 20 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
32.6%
14/43 • Number of events 94 • Up to 3 years
|
53.7%
29/54 • Number of events 175 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
32.6%
14/43 • Number of events 35 • Up to 3 years
|
44.4%
24/54 • Number of events 58 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
3/43 • Number of events 12 • Up to 3 years
|
5.6%
3/54 • Number of events 14 • Up to 3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/43 • Number of events 4 • Up to 3 years
|
1.9%
1/54 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43 • Number of events 6 • Up to 3 years
|
3.7%
2/54 • Number of events 9 • Up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.3%
1/43 • Number of events 19 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.7%
2/43 • Number of events 3 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/43 • Up to 3 years
|
7.4%
4/54 • Number of events 7 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
32.6%
14/43 • Number of events 31 • Up to 3 years
|
64.8%
35/54 • Number of events 109 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
7/43 • Number of events 14 • Up to 3 years
|
20.4%
11/54 • Number of events 13 • Up to 3 years
|
|
General disorders
Chills
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
1.9%
1/54 • Number of events 6 • Up to 3 years
|
|
General disorders
Edema face
|
2.3%
1/43 • Number of events 9 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
General disorders
Edema limbs
|
9.3%
4/43 • Number of events 22 • Up to 3 years
|
9.3%
5/54 • Number of events 30 • Up to 3 years
|
|
General disorders
Facial pain
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 4 • Up to 3 years
|
|
General disorders
Fatigue
|
76.7%
33/43 • Number of events 215 • Up to 3 years
|
92.6%
50/54 • Number of events 376 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/43 • Up to 3 years
|
9.3%
5/54 • Number of events 5 • Up to 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
1.9%
1/54 • Number of events 3 • Up to 3 years
|
|
General disorders
Generalized edema
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
9.3%
4/43 • Number of events 17 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
General disorders
Pain
|
9.3%
4/43 • Number of events 17 • Up to 3 years
|
7.4%
4/54 • Number of events 12 • Up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.3%
1/43 • Number of events 3 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
9.3%
4/43 • Number of events 5 • Up to 3 years
|
7.4%
4/54 • Number of events 5 • Up to 3 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
4.7%
2/43 • Number of events 7 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Thrush
|
0.00%
0/43 • Up to 3 years
|
7.4%
4/54 • Number of events 4 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 3 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Infections and infestations
Wound infection
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
3/43 • Number of events 3 • Up to 3 years
|
3.7%
2/54 • Number of events 4 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
4/43 • Number of events 5 • Up to 3 years
|
29.6%
16/54 • Number of events 47 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
14.0%
6/43 • Number of events 12 • Up to 3 years
|
22.2%
12/54 • Number of events 44 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.3%
7/43 • Number of events 8 • Up to 3 years
|
16.7%
9/54 • Number of events 21 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
11.6%
5/43 • Number of events 5 • Up to 3 years
|
7.4%
4/54 • Number of events 13 • Up to 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.0%
3/43 • Number of events 9 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Investigations
CPK increased
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Investigations
Cardiac troponin I increased
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Investigations
Creatinine increased
|
16.3%
7/43 • Number of events 21 • Up to 3 years
|
14.8%
8/54 • Number of events 22 • Up to 3 years
|
|
Investigations
Investigations - Other, specify
|
4.7%
2/43 • Number of events 23 • Up to 3 years
|
3.7%
2/54 • Number of events 7 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
11.6%
5/43 • Number of events 27 • Up to 3 years
|
33.3%
18/54 • Number of events 65 • Up to 3 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
29.6%
16/54 • Number of events 44 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
9.3%
4/43 • Number of events 12 • Up to 3 years
|
35.2%
19/54 • Number of events 50 • Up to 3 years
|
|
Investigations
Thyroid stimulating hormone increased
|
4.7%
2/43 • Number of events 4 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Investigations
Weight loss
|
16.3%
7/43 • Number of events 18 • Up to 3 years
|
5.6%
3/54 • Number of events 16 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
25.9%
14/54 • Number of events 24 • Up to 3 years
|
|
Metabolism and nutrition disorders
Acidosis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
55.8%
24/43 • Number of events 93 • Up to 3 years
|
48.1%
26/54 • Number of events 104 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
9.3%
5/54 • Number of events 5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.6%
8/43 • Number of events 56 • Up to 3 years
|
29.6%
16/54 • Number of events 68 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
4.7%
2/43 • Number of events 5 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.0%
6/43 • Number of events 22 • Up to 3 years
|
18.5%
10/54 • Number of events 36 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.3%
1/43 • Number of events 3 • Up to 3 years
|
7.4%
4/54 • Number of events 9 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.6%
5/43 • Number of events 8 • Up to 3 years
|
18.5%
10/54 • Number of events 21 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
11.1%
6/54 • Number of events 14 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.6%
5/43 • Number of events 31 • Up to 3 years
|
18.5%
10/54 • Number of events 24 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 4 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.2%
19/43 • Number of events 125 • Up to 3 years
|
24.1%
13/54 • Number of events 70 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.0%
3/43 • Number of events 14 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
6/43 • Number of events 22 • Up to 3 years
|
13.0%
7/54 • Number of events 28 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.7%
2/43 • Number of events 2 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.0%
6/43 • Number of events 14 • Up to 3 years
|
13.0%
7/54 • Number of events 14 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.7%
2/43 • Number of events 6 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.7%
2/43 • Number of events 10 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
5.6%
3/54 • Number of events 5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/43 • Number of events 3 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.3%
7/43 • Number of events 21 • Up to 3 years
|
1.9%
1/54 • Number of events 6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
11.6%
5/43 • Number of events 15 • Up to 3 years
|
18.5%
10/54 • Number of events 53 • Up to 3 years
|
|
Nervous system disorders
Dysarthria
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
4.7%
2/43 • Number of events 5 • Up to 3 years
|
7.4%
4/54 • Number of events 5 • Up to 3 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • Number of events 7 • Up to 3 years
|
16.7%
9/54 • Number of events 23 • Up to 3 years
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Paresthesia
|
2.3%
1/43 • Number of events 4 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.2%
13/43 • Number of events 66 • Up to 3 years
|
22.2%
12/54 • Number of events 80 • Up to 3 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Tremor
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43 • Number of events 20 • Up to 3 years
|
11.1%
6/54 • Number of events 21 • Up to 3 years
|
|
Psychiatric disorders
Confusion
|
7.0%
3/43 • Number of events 31 • Up to 3 years
|
9.3%
5/54 • Number of events 31 • Up to 3 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
5.6%
3/54 • Number of events 6 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
18.6%
8/43 • Number of events 12 • Up to 3 years
|
16.7%
9/54 • Number of events 26 • Up to 3 years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.0%
3/43 • Number of events 5 • Up to 3 years
|
1.9%
1/54 • Number of events 7 • Up to 3 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
9.3%
5/54 • Number of events 15 • Up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.3%
1/43 • Number of events 9 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
67.4%
29/43 • Number of events 215 • Up to 3 years
|
66.7%
36/54 • Number of events 207 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
69.8%
30/43 • Number of events 199 • Up to 3 years
|
74.1%
40/54 • Number of events 228 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
7.4%
4/54 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.3%
4/43 • Number of events 23 • Up to 3 years
|
5.6%
3/54 • Number of events 3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.6%
5/43 • Number of events 6 • Up to 3 years
|
7.4%
4/54 • Number of events 9 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.7%
2/43 • Number of events 4 • Up to 3 years
|
9.3%
5/54 • Number of events 6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.3%
1/43 • Number of events 12 • Up to 3 years
|
3.7%
2/54 • Number of events 9 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.6%
5/43 • Number of events 22 • Up to 3 years
|
3.7%
2/54 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
7.0%
3/43 • Number of events 11 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.3%
1/43 • Number of events 4 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
3.7%
2/54 • Number of events 6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • Number of events 9 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/43 • Up to 3 years
|
3.7%
2/54 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.3%
4/43 • Number of events 15 • Up to 3 years
|
13.0%
7/54 • Number of events 16 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.7%
2/43 • Number of events 24 • Up to 3 years
|
16.7%
9/54 • Number of events 10 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.3%
1/43 • Number of events 2 • Up to 3 years
|
3.7%
2/54 • Number of events 8 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
1.9%
1/54 • Number of events 2 • Up to 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/43 • Up to 3 years
|
1.9%
1/54 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
20.9%
9/43 • Number of events 48 • Up to 3 years
|
20.4%
11/54 • Number of events 51 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
9.3%
4/43 • Number of events 10 • Up to 3 years
|
7.4%
4/54 • Number of events 5 • Up to 3 years
|
|
Vascular disorders
Phlebitis
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
0.00%
0/54 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Number of events 1 • Up to 3 years
|
5.6%
3/54 • Number of events 3 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place