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Trial Outcomes & Findings for Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer (NCT NCT00509366)

NCT ID: NCT00509366

Last Updated: 2014-08-28

Results Overview

One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

1 year

Results posted on

2014-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
Cisplatin + Gemcitabine
Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
Cisplatin + Pemetrexed
Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
Pemetrexed + Gemcitabine
Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
Docetaxel + Gemcitabine
Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
Screen Failure
Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
Overall Study
STARTED
18
8
22
2
51
Overall Study
Assigned Treatment
18
8
22
2
0
Overall Study
COMPLETED
17
7
21
2
51
Overall Study
NOT COMPLETED
1
1
1
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Cisplatin + Gemcitabine
Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
Cisplatin + Pemetrexed
Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
Pemetrexed + Gemcitabine
Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
Docetaxel + Gemcitabine
Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
Screen Failure
Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
Overall Study
Not Treated (Screen Failure)
1
1
1
0
0

Baseline Characteristics

Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cisplatin + Gemcitabine
n=17 Participants
Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
Cisplatin + Pemetrexed
n=7 Participants
Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
Pemetrexed + Gemcitabine
n=21 Participants
Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
Docetaxel + Gemcitabine
n=2 Participants
Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
Screen Failure
n=54 Participants
Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
Total
n=101 Participants
Total of all reporting groups
Age, Continuous
62.53 years
STANDARD_DEVIATION 6.51 • n=5 Participants
61.43 years
STANDARD_DEVIATION 9.78 • n=7 Participants
62.14 years
STANDARD_DEVIATION 9.72 • n=5 Participants
59.00 years
STANDARD_DEVIATION 7.07 • n=4 Participants
61.24 years
STANDARD_DEVIATION 10.10 • n=21 Participants
61.61 years
STANDARD_DEVIATION 9.29 • n=10 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
0 Participants
n=4 Participants
20 Participants
n=21 Participants
40 Participants
n=10 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
2 Participants
n=7 Participants
12 Participants
n=5 Participants
2 Participants
n=4 Participants
34 Participants
n=21 Participants
61 Participants
n=10 Participants
Region of Enrollment
United States
17 participants
n=5 Participants
7 participants
n=7 Participants
21 participants
n=5 Participants
2 participants
n=4 Participants
54 participants
n=21 Participants
101 participants
n=10 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.

One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.

Outcome measures

Outcome measures
Measure
Treatment
n=47 Participants
Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients
19.15 percentage of treated patients
Interval 9.46 to 31.4

SECONDARY outcome

Timeframe: 1 Year

Population: Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.

Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.

Outcome measures

Outcome measures
Measure
Treatment
n=47 Participants
Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
Median Time to Progressive Disease
4.60 months
Interval 3.58 to 6.47

SECONDARY outcome

Timeframe: Baseline, Every 21 days for a maximum of 6 cycles

Population: Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.

The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.

Outcome measures

Outcome measures
Measure
Treatment
n=32 Participants
Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 1
0.15 units on a scale
Standard Error 1.76
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 2
-1.04 units on a scale
Standard Error 2.23
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 3
-1.28 units on a scale
Standard Error 2.97
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 4
-2.62 units on a scale
Standard Error 2.48
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 5
-6.14 units on a scale
Standard Error 3.96
Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Change from baseline to Cycle 6
-0.72 units on a scale
Standard Error 3.20

SECONDARY outcome

Timeframe: 3 years

Population: This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.

Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.

Outcome measures

Outcome data not reported

Adverse Events

Cisplatin Sensitive (Pre-Amendment)

Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths

Cisplatin Sensitive (Post-Amendment)

Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths

Cisplatin Resistant (Pre-Amendment)

Serious events: 12 serious events
Other events: 17 other events
Deaths: 0 deaths

Cisplatin Resistant (Post-Amendment)

Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths

Screen Failure

Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cisplatin Sensitive (Pre-Amendment)
n=16 participants at risk
Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
Cisplatin Sensitive (Post-Amendment)
n=8 participants at risk
Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
Cisplatin Resistant (Pre-Amendment)
n=17 participants at risk
Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
Cisplatin Resistant (Post-Amendment)
n=6 participants at risk
Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
Screen Failure
n=45 participants at risk
Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
Blood and lymphatic system disorders
Anemia
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Asystole
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Atrial flutter
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Cardiac disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Sinus tachycardia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Constipation
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Diarrhea
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Nausea
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Vomiting
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Fatigue
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Fever
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Injection site reaction
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Immune system disorders
Allergic reaction
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Bronchial infection
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Vagina
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Lung infection
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Upper respiratory infection
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Urinary tract infection
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Injury, poisoning and procedural complications
Aortic injury
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Injury, poisoning and procedural complications
Fracture
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Neutrophil count decreased
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Acidosis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Dehydration
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Ischemia cerebrovascular
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Nervous system disorders - Other
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Confusion
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Renal and urinary disorders
Acute kidney injury
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Dyspnea
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pneumothorax
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
6.7%
3/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Vascular disorders
Thromboembolic event
12.5%
2/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011

Other adverse events

Other adverse events
Measure
Cisplatin Sensitive (Pre-Amendment)
n=16 participants at risk
Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
Cisplatin Sensitive (Post-Amendment)
n=8 participants at risk
Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
Cisplatin Resistant (Pre-Amendment)
n=17 participants at risk
Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
Cisplatin Resistant (Post-Amendment)
n=6 participants at risk
Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
Screen Failure
n=45 participants at risk
Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
Metabolism and nutrition disorders
Hyperkalemia
12.5%
2/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypermagnesemia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypoalbuminemia
87.5%
14/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
82.4%
14/17 • May 2007 to December 2011
100.0%
6/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypocalcemia
87.5%
14/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
64.7%
11/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypoglycemia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypokalemia
62.5%
10/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
29.4%
5/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypomagnesemia
37.5%
6/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hyponatremia
62.5%
10/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
52.9%
9/17 • May 2007 to December 2011
100.0%
6/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Weight gain
12.5%
2/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Weight loss
25.0%
4/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
White blood cell decreased
56.2%
9/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
70.6%
12/17 • May 2007 to December 2011
100.0%
6/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Acidosis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Anorexia
75.0%
12/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
52.9%
9/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Dehydration
31.2%
5/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypercalcemia
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hyperglycemia
75.0%
12/16 • May 2007 to December 2011
75.0%
6/8 • May 2007 to December 2011
82.4%
14/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Blood and lymphatic system disorders
Anemia
87.5%
14/16 • May 2007 to December 2011
75.0%
6/8 • May 2007 to December 2011
88.2%
15/17 • May 2007 to December 2011
100.0%
6/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Atrial fibrillation
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Atrial flutter
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Cardiac disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Left ventricular systolic dysfunction
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Myocardial infarction
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Palpitations
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Sinus tachycardia
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Supraventricular tachycardia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Cardiac disorders
Ventricular arrhythmia
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Ear and labyrinth disorders
External ear inflammation
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Ear and labyrinth disorders
Hearing impaired
18.8%
3/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Ear and labyrinth disorders
Middle ear inflammation
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Ear and labyrinth disorders
Tinnitus
43.8%
7/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Blurred vision
18.8%
3/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Dry eye
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Extraocular muscle paresis
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Eye disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Eye pain
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Flashing lights
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Eye disorders
Watering eyes
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Abdominal distension
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Abdominal pain
18.8%
3/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Ascites
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Colitis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Constipation
37.5%
6/16 • May 2007 to December 2011
87.5%
7/8 • May 2007 to December 2011
70.6%
12/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Diarrhea
37.5%
6/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
35.3%
6/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Dry mouth
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Dyspepsia
18.8%
3/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Dysphagia
18.8%
3/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Flatulence
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Gastritis
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Gastrointestinal disorders - Other
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Hemorrhoidal hemorrhage
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Hemorrhoids
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Mucositis oral
25.0%
4/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
35.3%
6/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Nausea
81.2%
13/16 • May 2007 to December 2011
100.0%
8/8 • May 2007 to December 2011
70.6%
12/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Oral hemorrhage
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Rectal hemorrhage
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Rectal pain
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Stomach pain
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Gastrointestinal disorders
Vomiting
56.2%
9/16 • May 2007 to December 2011
75.0%
6/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Chills
18.8%
3/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Edema face
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Edema limbs
43.8%
7/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
58.8%
10/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Edema trunk
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Fatigue
81.2%
13/16 • May 2007 to December 2011
87.5%
7/8 • May 2007 to December 2011
88.2%
15/17 • May 2007 to December 2011
83.3%
5/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Fever
18.8%
3/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
52.9%
9/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
General disorders and administration site conditions - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Injection site reaction
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Non-cardiac chest pain
12.5%
2/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
General disorders
Pain
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Immune system disorders
Allergic reaction
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Immune system disorders
Immune system disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Bronchial infection
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Conjunctivitis infective
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Eye infection
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Gum infection
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Infections and infestations - Other
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Infections and infestations-Infection with Grade 3 or 4 neutrophils: Skin (cellulitis)
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Joint infection
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Lung infection
18.8%
3/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Mucosal infection
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Otitis media
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Sepsis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Sinusitis
12.5%
2/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Skin infection
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Upper respiratory infection
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Infections and infestations
Urinary tract infection
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Injury, poisoning and procedural complications
Aortic injury
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Injury, poisoning and procedural complications
Bruising
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Alanine aminotransferase increased
31.2%
5/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
82.4%
14/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Alkaline phosphatase increased
43.8%
7/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
64.7%
11/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Aspartate aminotransferase increased
37.5%
6/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
58.8%
10/17 • May 2007 to December 2011
83.3%
5/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Blood bilirubin increased
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Creatinine increased
56.2%
9/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Investigations - Other
6.2%
1/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Lipase increased
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Lymphocyte count decreased
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Neutrophil count decreased
68.8%
11/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
70.6%
12/17 • May 2007 to December 2011
100.0%
6/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Investigations
Platelet count decreased
56.2%
9/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
47.1%
8/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Metabolism and nutrition disorders
Hypophosphatemia
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Arthralgia
18.8%
3/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Back pain
18.8%
3/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Chest wall pain
12.5%
2/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
6.2%
1/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Myalgia
18.8%
3/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Musculoskeletal and connective tissue disorders
Pain in extremity
18.8%
3/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Dizziness
37.5%
6/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Dysgeusia
68.8%
11/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
41.2%
7/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Extrapyramidal disorder
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Facial nerve disorder
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Headache
37.5%
6/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
35.3%
6/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Memory impairment
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Nervous system disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Neuralgia
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Olfactory nerve disorder
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Peripheral motor neuropathy
56.2%
9/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
29.4%
5/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Peripheral sensory neuropathy
43.8%
7/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Syncope
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Nervous system disorders
Tremor
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Agitation
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Anxiety
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Confusion
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Depression
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Insomnia
50.0%
8/16 • May 2007 to December 2011
75.0%
6/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Psychiatric disorders
Personality change
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Renal and urinary disorders
Acute kidney injury
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Renal and urinary disorders
Renal and urinary disorders - Other
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Renal and urinary disorders
Urinary frequency
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Renal and urinary disorders
Urinary incontinence
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Reproductive system and breast disorders
Pelvic pain
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
25.0%
4/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
18.8%
3/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Cough
18.8%
3/16 • May 2007 to December 2011
37.5%
3/8 • May 2007 to December 2011
29.4%
5/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Dyspnea
62.5%
10/16 • May 2007 to December 2011
87.5%
7/8 • May 2007 to December 2011
64.7%
11/17 • May 2007 to December 2011
66.7%
4/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Epistaxis
18.8%
3/16 • May 2007 to December 2011
50.0%
4/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Hiccups
12.5%
2/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Hypoxia
18.8%
3/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
23.5%
4/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
6.7%
3/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
0.00%
0/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Respiratory, thoracic and mediastinal disorders
Voice alteration
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Alopecia
75.0%
12/16 • May 2007 to December 2011
62.5%
5/8 • May 2007 to December 2011
47.1%
8/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Hyperhidrosis
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
16.7%
1/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Rash acneiform
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Rash maculo-papular
37.5%
6/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
64.7%
11/17 • May 2007 to December 2011
50.0%
3/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
11.8%
2/17 • May 2007 to December 2011
33.3%
2/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Skin and subcutaneous tissue disorders
Skin ulceration
0.00%
0/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
17.6%
3/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Vascular disorders
Hypertension
6.2%
1/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Vascular disorders
Hypotension
18.8%
3/16 • May 2007 to December 2011
0.00%
0/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Vascular disorders
Phlebitis
6.2%
1/16 • May 2007 to December 2011
12.5%
1/8 • May 2007 to December 2011
5.9%
1/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011
Vascular disorders
Thromboembolic event
0.00%
0/16 • May 2007 to December 2011
25.0%
2/8 • May 2007 to December 2011
0.00%
0/17 • May 2007 to December 2011
0.00%
0/6 • May 2007 to December 2011
0.00%
0/45 • May 2007 to December 2011

Additional Information

Neal Ready, MD, PhD

Duke University

Phone: 919-681-6932

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place