Trial Outcomes & Findings for Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00660816)
NCT ID: NCT00660816
Last Updated: 2015-10-12
Results Overview
From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
18 months after enrollment of last patient
Results posted on
2015-10-12
Participant Flow
Participant milestones
| Measure |
Active Comparator
Alimta or Taxotere alone
|
Experimental
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
Reasons for withdrawal
| Measure |
Active Comparator
Alimta or Taxotere alone
|
Experimental
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Disease Progression
|
16
|
12
|
|
Overall Study
Complicating Disease
|
0
|
1
|
Baseline Characteristics
Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Active Comparator
n=24 Participants
Alimta or Taxotere alone
|
Experimental
n=22 Participants
Alimta or Taxotere and Tarceva
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
FULL_RANGE 11.08 • n=39 Participants
|
63.6 years
FULL_RANGE 10.62 • n=41 Participants
|
65.3 years
FULL_RANGE 10.78 • n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=39 Participants
|
22 participants
n=41 Participants
|
46 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 18 months after enrollment of last patientFrom the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.
Outcome measures
| Measure |
Active Comparator
n=24 Participants
Alimta or Taxotere alone
|
Experimental
n=22 Participants
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Progression-free Survival
|
5.5 Months
Interval 2.6 to 6.6
|
4.4 Months
Interval 2.9 to 7.5
|
SECONDARY outcome
Timeframe: 36 months after enrollment of last patientMeasured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors
Outcome measures
| Measure |
Active Comparator
n=24 Participants
Alimta or Taxotere alone
|
Experimental
n=22 Participants
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Overall Survival
|
16.4 Months
Interval 6.6 to 39.0
|
14.2 Months
Interval 7.0 to 23.9
|
SECONDARY outcome
Timeframe: 36 months after enrollment of last evaluable patientPopulation: Patients with a complete response, partial response, stable disease, or progressive disease
Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution
Outcome measures
| Measure |
Active Comparator
n=15 Participants
Alimta or Taxotere alone
|
Experimental
n=18 Participants
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Response Rate
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 36 months after enrollment of last patientPopulation: Patients with a complete response, partial response, stable disease, or progressive disease
Estimated based on number of evaluable patients with complete response, partial response or stable disease
Outcome measures
| Measure |
Active Comparator
n=15 Participants
Alimta or Taxotere alone
|
Experimental
n=18 Participants
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)
|
15 participants
|
16 participants
|
Adverse Events
Active Comparator
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Experimental
Serious events: 17 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator
n=24 participants at risk
Alimta or Taxotere alone
|
Experimental
n=22 participants at risk
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/24
|
4.5%
1/22
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24
|
4.5%
1/22
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/24
|
4.5%
1/22
|
|
Gastrointestinal disorders
Crohn's exacerbation
|
0.00%
0/24
|
4.5%
1/22
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
|
4.5%
1/22
|
|
General disorders
Fatigue
|
0.00%
0/24
|
4.5%
1/22
|
|
General disorders
Multi-organ failure
|
0.00%
0/24
|
4.5%
1/22
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24
|
0.00%
0/22
|
|
Infections and infestations
Lung infection
|
4.2%
1/24
|
9.1%
2/22
|
|
Infections and infestations
Sepsis
|
0.00%
0/24
|
4.5%
1/22
|
|
Infections and infestations
Skin infection
|
0.00%
0/24
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/24
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24
|
4.5%
1/22
|
|
Psychiatric disorders
Confusion
|
0.00%
0/24
|
9.1%
2/22
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/24
|
4.5%
1/22
|
|
Vascular disorders
Thromboembolic event
|
8.3%
2/24
|
0.00%
0/22
|
Other adverse events
| Measure |
Active Comparator
n=24 participants at risk
Alimta or Taxotere alone
|
Experimental
n=22 participants at risk
Alimta or Taxotere and Tarceva
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
12/24 • Number of events 17
|
36.4%
8/22 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
41.7%
10/24 • Number of events 16
|
36.4%
8/22 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
6/24 • Number of events 7
|
50.0%
11/22 • Number of events 17
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 4
|
27.3%
6/22 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
4/24 • Number of events 5
|
4.5%
1/22 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • Number of events 6
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/24
|
9.1%
2/22 • Number of events 5
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's exacerbation
|
0.00%
0/24
|
4.5%
1/22 • Number of events 5
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
45.8%
11/24 • Number of events 25
|
68.2%
15/22 • Number of events 64
|
|
Investigations
White blood cell decreased
|
41.7%
10/24 • Number of events 37
|
54.5%
12/22 • Number of events 43
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
9/24 • Number of events 11
|
27.3%
6/22 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
33.3%
8/24 • Number of events 24
|
31.8%
7/22 • Number of events 21
|
|
Investigations
Alkaline phosphatase increased
|
20.8%
5/24 • Number of events 7
|
31.8%
7/22 • Number of events 8
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
3/24 • Number of events 3
|
31.8%
7/22 • Number of events 9
|
|
Investigations
Platelet count decreased
|
16.7%
4/24 • Number of events 10
|
27.3%
6/22 • Number of events 19
|
|
Investigations
Weight loss
|
4.2%
1/24 • Number of events 1
|
22.7%
5/22 • Number of events 8
|
|
Investigations
Creatinine increased
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Lymphocyte count increased
|
4.2%
1/24 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Weight gain
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
|
Investigations
INR increased
|
0.00%
0/24
|
4.5%
1/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
9/24 • Number of events 16
|
50.0%
11/22 • Number of events 27
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
8/24 • Number of events 14
|
36.4%
8/22 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
6/24 • Number of events 8
|
27.3%
6/22 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
3/24 • Number of events 4
|
22.7%
5/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
2/24 • Number of events 3
|
22.7%
5/22 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
2/24 • Number of events 2
|
18.2%
4/22 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1
|
18.2%
4/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
4/24 • Number of events 4
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/24
|
13.6%
3/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
1/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Fatigue
|
58.3%
14/24 • Number of events 29
|
59.1%
13/22 • Number of events 28
|
|
General disorders
Edema limbs
|
25.0%
6/24 • Number of events 10
|
13.6%
3/22 • Number of events 4
|
|
General disorders
Non-cardiac chest pain
|
20.8%
5/24 • Number of events 5
|
18.2%
4/22 • Number of events 4
|
|
General disorders
Pain
|
8.3%
2/24 • Number of events 3
|
22.7%
5/22 • Number of events 6
|
|
General disorders
Fever
|
12.5%
3/24 • Number of events 3
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Chills
|
8.3%
2/24 • Number of events 2
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Flu like symptoms
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Localized edema
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
6/24 • Number of events 14
|
50.0%
11/22 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
6/24 • Number of events 7
|
31.8%
7/22 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.2%
1/24 • Number of events 1
|
9.1%
2/22 • Number of events 3
|
|
Reproductive system and breast disorders
Epistaxis
|
0.00%
0/24
|
13.6%
3/22 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/24
|
4.5%
1/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
3/24 • Number of events 3
|
31.8%
7/22 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
2/24 • Number of events 4
|
31.8%
7/22 • Number of events 46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • Number of events 2
|
27.3%
6/22 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
2/24 • Number of events 2
|
18.2%
4/22 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/24
|
9.1%
2/22 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
"Skin and subcutaneous tissue disorders - Other, specify"
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24
|
4.5%
1/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
45.8%
11/24 • Number of events 29
|
50.0%
11/22 • Number of events 23
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 5
|
9.1%
2/22 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
2/24 • Number of events 2
|
13.6%
3/22 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1
|
13.6%
3/22 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Number of events 5
|
4.5%
1/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
"Musculoskeletal and connective tissue disorder - Other, specify"
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
6/24 • Number of events 10
|
31.8%
7/22 • Number of events 13
|
|
Psychiatric disorders
Anxiety
|
16.7%
4/24 • Number of events 4
|
18.2%
4/22 • Number of events 4
|
|
Psychiatric disorders
Depression
|
12.5%
3/24 • Number of events 3
|
13.6%
3/22 • Number of events 4
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
4/24 • Number of events 5
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • Number of events 5
|
9.1%
2/22 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
2/24 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Lung infection
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 3
|
|
Infections and infestations
"Infections and infestations - Other, specify"
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/24
|
4.5%
1/22 • Number of events 3
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Flushing
|
12.5%
3/24 • Number of events 4
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
16.7%
4/24 • Number of events 4
|
0.00%
0/22
|
|
Vascular disorders
Thromboembolic event
|
12.5%
3/24 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hypertension
|
12.5%
3/24 • Number of events 4
|
0.00%
0/22
|
|
Vascular disorders
Lymphocele
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Eye disorders
Blurred vision
|
12.5%
3/24 • Number of events 4
|
9.1%
2/22 • Number of events 2
|
|
Eye disorders
Watering eyes
|
8.3%
2/24 • Number of events 2
|
13.6%
3/22 • Number of events 5
|
|
Eye disorders
Dry eye
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/24
|
4.5%
1/22 • Number of events 2
|
|
Eye disorders
"Eye disorders - Other, specify"
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
"Renal and urinary disorders - Other, specify"
|
8.3%
2/24 • Number of events 2
|
9.1%
2/22 • Number of events 4
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
1/24 • Number of events 1
|
13.6%
3/22 • Number of events 4
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
2/24 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
1/24 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/24
|
4.5%
1/22 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
"Ear and labyrinth disorders - Other, specify"
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place