Trial Outcomes & Findings for Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor (NCT NCT00356525)
NCT ID: NCT00356525
Last Updated: 2010-08-17
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
baseline to time of response (up to 17.5 months)
Results posted on
2010-08-17
Participant Flow
Participant milestones
| Measure |
Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
7
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
7
|
9
|
Reasons for withdrawal
| Measure |
Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
8
|
5
|
4
|
2
|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
2
|
1
|
|
Overall Study
Protocol Entry Criteria Not Met
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
Baseline characteristics by cohort
| Measure |
Less Than One Year: Pemetrexed
n=14 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
n=11 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
n=7 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
n=9 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=65 years
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Age, Customized
>65 years
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Disease Stage at Initial Diagnosis
Stage IV
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0 - Fully Active
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
History of Brain Metastates
No
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
History of Brain Metastates
Yes
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Prior Systemic Therapy
Adjuvant
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Prior Systemic Therapy
Neoadjuvant
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity
East Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity
West Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity
Caucasian
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to time of response (up to 17.5 months)Population: Number of randomized participants in each category.
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
Less Than One Year: Pemetrexed
n=14 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
n=11 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
n=7 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
n=9 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Objective Tumor Response
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Objective Tumor Response
Partial Response
|
7 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Objective Tumor Response
Stable Disease
|
3 participants
|
9 participants
|
5 participants
|
6 participants
|
|
Objective Tumor Response
Progressive Disease
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Objective Tumor Response
Unknown
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: baseline to trial termination (17.5 months)Population: Number of randomized participants in each category.
Overall survival is the number of participants who were alive when the trial was terminated.
Outcome measures
| Measure |
Less Than One Year: Pemetrexed
n=14 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
n=11 Participants
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
n=7 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
n=9 Participants
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Overall Survival
|
6 participants alive
Interval 1.64 to 16.1
|
4 participants alive
Interval 0.99 to 11.66
|
6 participants alive
Interval 4.4 to 17.58
|
7 participants alive
Interval 0.16 to 14.78
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 17.5 months)Population: Outcome measure was not analyzed due to insufficient data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time of response to progressive disease (up to 17.5 months)Population: Outcome measure was not analyzed due to insufficient data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to stopping treatment (up to 17.5 months)Population: Outcome measure was not analyzed due to insufficient data.
Outcome measures
Outcome data not reported
Adverse Events
Less Than One Year: Pemetrexed
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Less Than One Year: Pemetrexed + Gemcitabine
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
One Year or Greater: Pemetrexed + Carboplatin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
One Year or Greater: Pemetrexed + Gemcitabine
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Less Than One Year: Pemetrexed
n=14 participants at risk
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
n=11 participants at risk
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
n=7 participants at risk
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
n=9 participants at risk
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
Other adverse events
| Measure |
Less Than One Year: Pemetrexed
n=14 participants at risk
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
Less Than One Year: Pemetrexed + Gemcitabine
n=11 participants at risk
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Carboplatin
n=7 participants at risk
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
|
One Year or Greater: Pemetrexed + Gemcitabine
n=9 participants at risk
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
|
|---|---|---|---|---|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
14.3%
2/14 • Number of events 2
|
27.3%
3/11 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
6/14 • Number of events 10
|
90.9%
10/11 • Number of events 15
|
14.3%
1/7 • Number of events 3
|
33.3%
3/9 • Number of events 6
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
2/14 • Number of events 2
|
27.3%
3/11 • Number of events 4
|
0.00%
0/7
|
11.1%
1/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.4%
3/14 • Number of events 5
|
36.4%
4/11 • Number of events 4
|
28.6%
2/7 • Number of events 8
|
33.3%
3/9 • Number of events 9
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.4%
3/14 • Number of events 4
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
2/14 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Atrial flutter
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac valve disease
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Coronary artery disease
|
14.3%
2/14 • Number of events 2
|
36.4%
4/11 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Myocardial ischaemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 3
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Eye disorders
Eye allergy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Eye disorders
Eye pruritus
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Eye disorders
Glaucoma
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Eye disorders
Macular degeneration
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
42.9%
6/14 • Number of events 7
|
54.5%
6/11 • Number of events 6
|
42.9%
3/7 • Number of events 4
|
33.3%
3/9 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
50.0%
7/14 • Number of events 8
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Number of events 15
|
54.5%
6/11 • Number of events 10
|
42.9%
3/7 • Number of events 7
|
66.7%
6/9 • Number of events 10
|
|
Gastrointestinal disorders
Oesophagitis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 5
|
36.4%
4/11 • Number of events 4
|
14.3%
1/7 • Number of events 2
|
33.3%
3/9 • Number of events 4
|
|
General disorders
Asthenia
|
14.3%
2/14 • Number of events 3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Chest discomfort
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Chest pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Chills
|
14.3%
2/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Face oedema
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Fatigue
|
78.6%
11/14 • Number of events 17
|
100.0%
11/11 • Number of events 21
|
71.4%
5/7 • Number of events 7
|
66.7%
6/9 • Number of events 6
|
|
General disorders
Gait disturbance
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Malaise
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Mucosal dryness
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Mucosal inflammation
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Non-cardiac chest pain
|
14.3%
2/14 • Number of events 3
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Oedema
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Oedema peripheral
|
0.00%
0/14
|
27.3%
3/11 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Pain
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
General disorders
Pyrexia
|
21.4%
3/14 • Number of events 5
|
45.5%
5/11 • Number of events 7
|
0.00%
0/7
|
22.2%
2/9 • Number of events 3
|
|
General disorders
Secretion discharge
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14
|
18.2%
2/11 • Number of events 3
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Candidiasis
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Chronic sinusitis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Empyema
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Infection
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
21.4%
3/14 • Number of events 3
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Staphylococcal infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Incision site pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Aspiration pleural cavity
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Blood glucose increased
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Cardiac murmur
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Glomerular filtration rate abnormal
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
22.2%
2/9 • Number of events 5
|
|
Investigations
Platelet count decreased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Prothrombin time ratio
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Sputum culture positive
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
Troponin increased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Investigations
White blood cell count decreased
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 4
|
|
Investigations
White blood cell count increased
|
7.1%
1/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
4/14 • Number of events 4
|
18.2%
2/11 • Number of events 3
|
28.6%
2/7 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
4/14 • Number of events 5
|
36.4%
4/11 • Number of events 7
|
28.6%
2/7 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
21.4%
3/14 • Number of events 4
|
0.00%
0/11
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Fluid retention
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
1/14 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
2/14 • Number of events 3
|
9.1%
1/11 • Number of events 3
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
35.7%
5/14 • Number of events 5
|
27.3%
3/11 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2
|
27.3%
3/11 • Number of events 3
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
2/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
33.3%
3/9 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Anosmia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Ataxia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
21.4%
3/14 • Number of events 3
|
18.2%
2/11 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Number of events 2
|
18.2%
2/11 • Number of events 3
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Myasthenia gravis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Neuropathy peripheral
|
7.1%
1/14 • Number of events 1
|
45.5%
5/11 • Number of events 6
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Radial nerve palsy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Sedation
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Psychiatric disorders
Anxiety
|
28.6%
4/14 • Number of events 4
|
36.4%
4/11 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Depression
|
14.3%
2/14 • Number of events 2
|
54.5%
6/11 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Number of events 2
|
36.4%
4/11 • Number of events 4
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
14.3%
2/14 • Number of events 2
|
36.4%
4/11 • Number of events 4
|
0.00%
0/7
|
44.4%
4/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.7%
5/14 • Number of events 5
|
36.4%
4/11 • Number of events 4
|
57.1%
4/7 • Number of events 6
|
22.2%
2/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
2/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
57.1%
8/14 • Number of events 8
|
54.5%
6/11 • Number of events 7
|
57.1%
4/7 • Number of events 5
|
33.3%
3/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
28.6%
4/14 • Number of events 4
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
2/14 • Number of events 3
|
18.2%
2/11 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 3
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2
|
27.3%
3/11 • Number of events 7
|
28.6%
2/7 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/14
|
9.1%
1/11 • Number of events 2
|
0.00%
0/7
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Surgical and medical procedures
Mechanical ventilation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Surgical and medical procedures
Thoracotomy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/7
|
0.00%
0/9
|
|
Vascular disorders
Haematoma
|
0.00%
0/14
|
0.00%
0/11
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
|
Vascular disorders
Hypertension
|
35.7%
5/14 • Number of events 5
|
54.5%
6/11 • Number of events 6
|
71.4%
5/7 • Number of events 5
|
55.6%
5/9 • Number of events 5
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/14
|
0.00%
0/11
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/7
|
0.00%
0/9
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60