Trial Outcomes & Findings for Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations (NCT NCT00977470)
NCT ID: NCT00977470
Last Updated: 2025-10-15
Results Overview
A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
From start of treatment until report of disease progression, assessed up to 10 years.
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
Erlotinib
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
38
|
38
|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Erlotinib
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
32
|
30
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
clinical decline
|
0
|
1
|
|
Overall Study
prolonged recovery post-surgery
|
0
|
1
|
|
Overall Study
Still on-study
|
2
|
0
|
Baseline Characteristics
Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations
Baseline characteristics by cohort
| Measure |
Erlotinib
n=38 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 Participants
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
65 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Smoking History
Never smoked
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Smoking History
<= 10 pack years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Smoking History
> 10 pack years/current
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Histology
Non-small cell lung cancer, Not Otherwise Specifie
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Brain metastases
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Prior chemotherapy
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until report of disease progression, assessed up to 10 years.A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.
Outcome measures
| Measure |
Erlotinib
n=38 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 Participants
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Median Progression Free Survival
|
10.8 months
Interval 9.0 to 13.6
|
10.8 months
Interval 7.0 to 14.6
|
PRIMARY outcome
Timeframe: Nine monthsThis trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus hydroxychloroquine (HCQ) arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test. Progression is defined as at least a 20% increase in the size of existing lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Erlotinib
n=38 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 Participants
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Nine-month Progression-free Survival Rate
|
71 percentage of participants
Interval 53.0 to 83.0
|
52 percentage of participants
Interval 35.0 to 67.0
|
SECONDARY outcome
Timeframe: 2 yearsTo evaluate the safety of treatment with erlotinib with and without hydroxychloroquine (HCQ). All participants receiving study treatment were evaluated for safety. Parameters included laboratory tests, hematological abnormalities, physical exam findings and spontaneous reports of adverse events reported by participants. Toxicities were evaluated and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = fatal.
Outcome measures
| Measure |
Erlotinib
n=38 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 Participants
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Diarrhea
|
30 Participants
|
32 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Rash
|
17 Participants
|
21 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Fatigue
|
15 Participants
|
21 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Grade 3 Fatigue
|
1 Participants
|
7 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Nausea
|
11 Participants
|
21 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Anorexia
|
9 Participants
|
11 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Taste changes
|
9 Participants
|
9 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Grade 3 Taste changes
|
0 Participants
|
1 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Alopecia
|
5 Participants
|
7 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Weight loss
|
5 Participants
|
7 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Ocular toxicity
|
6 Participants
|
4 Participants
|
|
Treatment Related Toxicity, > 10% Frequency, Any Grade
Grade 4 or 5 events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 1 participant in each arm (2 participants total) did not have any scans done after baseline and therefore response could not be assessed.
Response is assessed via spiral CT scan, done at baseline and after every 2 cycles of study treatment. Standard RECIST (Response Evaluation Criteria in Solid Tumors) was used. Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the size of target lesions, as compared to baseline; Progressive Disease (PD) = at least at 20% increase in the size of target lesions, or the appearance of one or more new lesions; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Response rate = CR + PR. Disease control rate = CR + PR + SD
Outcome measures
| Measure |
Erlotinib
n=37 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=37 Participants
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Complete Response
|
1 Participants
|
2 Participants
|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Partial Response
|
23 Participants
|
19 Participants
|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Stable Disease
|
10 Participants
|
10 Participants
|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Progressive Disease
|
3 Participants
|
6 Participants
|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Response Rate
|
24 Participants
|
21 Participants
|
|
Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
Disease Control Rate
|
34 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Until deathOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Until disease progression (median of 10.8 months)Population: Due to technical reasons, this assay was not ready and therefore circulating tumor cell analysis was not done.
Serial circulating tumor cell (CTC) analyses will be performed on peripheral blood and correlated with disease response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Tumor tissue analysis was not performed for this correlative outcome.
Correlation of molecular and genetic tumor characteristics with disease response. Genomic DNA will be extracted from tumor tissue and direct sequencing analysis will be performed to identify additional mutations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Only 2 participants were enrolled in this pilot companion study
\[18F\]-FMISO-PET/CT was performed on a 64-slice PET/CT scanner and tracer uptake was assessed using SUV (standardized uptake value), normalizing the radioactivity measured in tissue by the injected dose and the body weight of the patient. Mean and maximum SUV and threshold volume of FMISO uptake were measured to quantify the extent of hypoxia in the primary tumor. Imaging was performed before and after initiation of therapy with erlotinib.
Outcome measures
| Measure |
Erlotinib
n=2 Participants
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.
|
2 Participants
|
0 Participants
|
Adverse Events
Erlotinib
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Erlotinib and Hydroxychloroquine
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=38 participants at risk
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 participants at risk
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection, nos
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Constitutional disorders - other
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Skin - pain
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - other
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Death NOS
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Pulmonary embolism
|
2.6%
1/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
Other adverse events
| Measure |
Erlotinib
n=38 participants at risk
Erlotinib: 150 mg taken orally once daily
|
Erlotinib and Hydroxychloroquine
n=38 participants at risk
Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Immune system disorders
Allergy-other
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Ear and labyrinth disorders
Hearing-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Investigations
Hemoglobin
|
10.5%
4/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Leukocytes
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Neutrophils
|
2.6%
1/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Platelets
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Cardiac disorders
Arrhythmia-other
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Hypertension
|
26.3%
10/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
15.8%
6/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Cardiac disorders
Cardiac-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Fatigue
|
65.8%
25/38 • Number of events 32 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
71.1%
27/38 • Number of events 44 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Fever w/o neutropenia
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Psychiatric disorders
Insomnia
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
26.3%
10/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Rigors/chills
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Sweating
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Investigations
Weight loss
|
18.4%
7/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
21.1%
8/38 • Number of events 9 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Constitutional, other
|
13.2%
5/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Investigations
INR
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Chelitis
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.6%
12/38 • Number of events 18 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
31.6%
12/38 • Number of events 13 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Flushing
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
6/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
26.3%
10/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
52.6%
20/38 • Number of events 31 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
34.2%
13/38 • Number of events 18 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
47.4%
18/38 • Number of events 25 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
55.3%
21/38 • Number of events 28 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
52.6%
20/38 • Number of events 25 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
21.1%
8/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Investigations
ADH secretion abnormality (eg SIADH)
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Endocrine disorders
Hypoparathyroidism
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Endocrine disorders
Hyopthyroidism
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Endocrine disorders
Endocrine-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Growth and Development, Other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.2%
13/38 • Number of events 15 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
39.5%
15/38 • Number of events 23 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Constipation
|
31.6%
12/38 • Number of events 13 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
28.9%
11/38 • Number of events 12 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
86.8%
33/38 • Number of events 43 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
84.2%
32/38 • Number of events 44 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.2%
5/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, anus
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.6%
1/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) pharynx
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Nausea
|
47.4%
18/38 • Number of events 22 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
60.5%
23/38 • Number of events 38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Taste disturbance
|
26.3%
10/38 • Number of events 11 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
26.3%
10/38 • Number of events 14 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
7/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
23.7%
9/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
GI-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 9 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Anus, hemorrhage
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Reproductive system and breast disorders
Vagina, hemorrhage
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Lung, hemorrhage
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
15.8%
6/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Hemorrhage-other
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ gr3-4 neut, ungual (nails)
|
2.6%
1/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, bladder
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, bronchus
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, ungual
|
7.9%
3/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
10.5%
4/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
10.5%
4/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, vagina
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC eye NOS
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC joint
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC lung
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC oral cavity/gums
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC ungual (nails)
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC upper airway NOS
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection w/ unk ANC urinary tract NOS
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Infections and infestations
Infection-other
|
10.5%
4/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Edema limb
|
15.8%
6/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
18.4%
7/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
13.2%
5/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
15.8%
6/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Bilirubin
|
10.5%
4/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Creatinine
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.8%
6/38 • Number of events 9 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
15.8%
6/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Nonneuropathic lower extr muscle weak
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Nonneuropathic generalized weakness
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
15.8%
6/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Cognitive disturbance
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Dizziness
|
28.9%
11/38 • Number of events 12 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Psychiatric disorders
Anxiety
|
28.9%
11/38 • Number of events 11 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Psychiatric disorders
Depression
|
15.8%
6/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
10.5%
4/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Neuropathy-motor
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Neuropathy-sensory
|
13.2%
5/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Seizure
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Nervous system disorders
Neurologic-other
|
23.7%
9/38 • Number of events 9 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Cataract
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Dry eye syndrome
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 5 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Eyelid dysfunction
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Glaucoma
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Double vision
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Retinopathy
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Vision-blurred
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Eye disorders
Ocular-other
|
21.1%
8/38 • Number of events 9 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Abdomen, pain
|
15.8%
6/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
26.3%
10/38 • Number of events 13 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Breast, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Buttock, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Chest/thoracic pain NOS
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Esophagus, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Ear and labyrinth disorders
External ear, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
23.7%
9/38 • Number of events 11 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Face, pain
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Head/headache
|
28.9%
11/38 • Number of events 12 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
18.4%
7/38 • Number of events 7 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Lip, pain
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Blood and lymphatic system disorders
Lymph node, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
2.6%
1/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Oral gums, pain
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Pain NOS
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
7.9%
3/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Pelvic, pain
|
5.3%
2/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Musculoskeletal and connective tissue disorders
Pleura, pain
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
10.5%
4/38 • Number of events 4 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Stomach, pain
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Gastrointestinal disorders
Throat/pharynx/larynx, pain
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Reproductive system and breast disorders
Vagina, pain
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Pain-other
|
21.1%
8/38 • Number of events 8 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
21.1%
8/38 • Number of events 10 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.5%
23/38 • Number of events 24 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
42.1%
16/38 • Number of events 16 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.1%
16/38 • Number of events 21 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
31.6%
12/38 • Number of events 14 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
13.2%
5/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
15.8%
6/38 • Number of events 6 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Renal and urinary disorders
Renal/GU-other
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast volume/hypoplasia
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Reproductive system and breast disorders
Irregular menses
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Reproductive system and breast disorders
Sexual/Reproductive function-Other
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
General disorders
Flu-like syndrome
|
7.9%
3/38 • Number of events 3 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.3%
2/38 • Number of events 2 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
|
Vascular disorders
Vascular-Other (Specify)
|
2.6%
1/38 • Number of events 1 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
0.00%
0/38 • 1 year
Adverse events were collected via physical exam, eye exam and laboratory test. Additionally, participants were questioned at each study visit regarding other events not collected by the above methods.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place