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Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00527735
First received: September 7, 2007
Last updated: June 11, 2012
Last verified: June 2012
Results First Received: February 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.

Reporting Groups
  Description
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Ipilimumab + Paclitaxel/Carboplatin (Sequential) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.

Participant Flow:   Overall Study
    Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)   Ipilimumab + Paclitaxel/Carboplatin (Sequential)   Placebo + Paclitaxel/Carboplatin
STARTED   113 [1]   109 [1]   109 [1] 
COMPLETED   5 [2]   2 [2]   2 [2] 
NOT COMPLETED   108   107   107 
Disease progression                47                61                53 
Death                23                13                15 
Completed treatment in treatment phase                14                13                18 
Adverse Event                10                6                7 
Not identified                5                5                5 
Withdrawal by Subject                5                4                3 
No longer met study criteria                2                2                1 
Lost to Follow-up                0                0                3 
Poor compliance or noncompliance                0                1                1 
Completed treatment during maintenance                2                2                1 
[1] Treated
[2] Still on treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Total Total of all reporting groups

Baseline Measures
   Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)   Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)   Placebo + Paclitaxel/Carboplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 113   110   111   334 
Age, Customized [1] 
[Units: Participants]
       
Younger than 65 years   79   73   76   228 
65 years and older   34   37   35   106 
[1] Age of participants who received treatment.
Gender 
[Units: Participants]
       
Female   27   29   29   85 
Male   86   81   82   249 
Age Customized, by Disease Type [1] 
[Units: Participants]
       
Younger than 65 years (NSCLC patients)   44   44   40   128 
65 years and older (NSCLC patients)   26   24   26   76 
Younger than 65 years (SCLC patients)   35   29   36   100 
65 years and older (SCLC patients)   8   13   9   30 
[1] NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Gender, by Disease Type [1] 
[Units: Participants]
       
Female (NSCLC patients)   17   19   17   53 
Male (NSCLC patients)   53   49   49   151 
Female (SCLC patients)   10   10   12   32 
Male (SCLC patients)   33   32   33   98 
[1] NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer
Disease Stage at Study Entry [1] 
[Units: Participants]
       
Stage IIIB (NSCLC patients)   11   7   17   35 
Stage IV (NSCLC patients)   59   61   49   169 
Extensive (SCLC patients)   43   42   44   129 
Recurrent disease (SCLC patients)   0   0   1   1 
[1] NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer. Staging of NSCLC is based on the findings of several clinical tests, including magnetic resonance imaging scans and fine needle biopsy. Stages range from 1 (best prognosis) to IV (worst prognosis). Stage I cancer is confined to the lung. Stages II and III cancers are locally advanced. Stage IV cancer has spread outside the lung to other organs. SCLC is staged using a 2-tiered system: Limited stage SCLC is confined to its area of origin in the lung and lumph nodes. Extensive-stage SCLC has spread beyond the lung to other organs.
Cell Type [1] 
[Units: Participants]
       
Adenocarcinoma (NSCLC patients)   35   30   38   103 
Bronchoalveolar carcinoma (NSCLC patients)   1   1   0   2 
Large-cell carcinoma (NSCLC patients)   6   11   7   24 
Other (NSCLC patients)   6   4   3   13 
Squamous-cell carcinoma (NSCLC patients)   21   21   15   57 
Unknown (NSCLC patients)   1   1   3   5 
Other (SCLC patients)   2   2   0   4 
Small-cell carcinoma (SCLC patients)   41   38   45   124 
Unknown (SCLC patients)   0   1   0   1 
Not reported (SCLC patients)   0   1   0   1 
[1] NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)   [ Time Frame: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months) ]

2.  Secondary:   Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria   [ Time Frame: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months) ]

3.  Secondary:   Overall Survival in Participants With NSCLC   [ Time Frame: Randomization date to date of death (of censored, maximum reached: 26.5 months) ]

4.  Secondary:   Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC   [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance ]

5.  Secondary:   Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)   [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance ]

6.  Secondary:   Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC   [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months) ]

7.  Secondary:   Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC   [ Time Frame: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months) ]

8.  Secondary:   Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade   [ Time Frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) ]

9.  Secondary:   Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade   [ Time Frame: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ]

10.  Secondary:   irPFS in Participants With SCLC Per irRC   [ Time Frame: Randomization date to date of irPD or death (maximum reached: 22 months) ]

11.  Secondary:   Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade   [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ]

12.  Secondary:   Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings   [ Time Frame: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ]

13.  Secondary:   Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade   [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ]

14.  Secondary:   Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline   [ Time Frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ]

15.  Secondary:   Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade   [ Time Frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) ]

16.  Secondary:   Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade   [ Time Frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment ]

17.  Secondary:   Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade   [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ]

18.  Secondary:   Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade   [ Time Frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment ]

19.  Secondary:   Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria   [ Time Frame: Randomization date to date of progression or death (of censored, maximum reached: 22 months) ]

20.  Secondary:   Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings   [ Time Frame: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment ]

21.  Secondary:   Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline   [ Time Frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ]

22.  Secondary:   Overall Survival in Participants With SCLC   [ Time Frame: Randomization date to date of death (of censored, maximum reached: 22 months) ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo + Paclitaxel/Carboplatin NSCLC During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
Placebo + Paclitaxel/Carboplatin SCLC During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.

Serious Adverse Events
    Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC   Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC   Placebo + Paclitaxel/Carboplatin NSCLC   Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC   Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC   Placebo + Paclitaxel/Carboplatin SCLC
Total, Serious Adverse Events             
# participants affected / at risk   49/71 (69.01%)   36/67 (53.73%)   33/65 (50.77%)   25/42 (59.52%)   21/42 (50.00%)   20/44 (45.45%) 
Blood and lymphatic system disorders             
ANAEMIA † 1             
# participants affected / at risk   4/71 (5.63%)   4/67 (5.97%)   1/65 (1.54%)   0/42 (0.00%)   2/42 (4.76%)   2/44 (4.55%) 
FEBRILE NEUTROPENIA † 1             
# participants affected / at risk   2/71 (2.82%)   1/67 (1.49%)   2/65 (3.08%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
LEUKOCYTOSIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
NEUTROPENIA † 1             
# participants affected / at risk   3/71 (4.23%)   0/67 (0.00%)   3/65 (4.62%)   0/42 (0.00%)   3/42 (7.14%)   3/44 (6.82%) 
PANCYTOPENIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
THROMBOCYTOPENIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   2/65 (3.08%)   0/42 (0.00%)   3/42 (7.14%)   1/44 (2.27%) 
LEUKOPENIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Cardiac disorders             
PERICARDIAL EFFUSION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ACUTE MYOCARDIAL INFARCTION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ATRIAL FIBRILLATION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CARDIAC FAILURE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
TACHYARRHYTHMIA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
ANGINA PECTORIS † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
MYOCARDIAL INFARCTION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CARDIAC FAILURE CONGESTIVE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
CARDIO-RESPIRATORY ARREST † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
VENTRICULAR FIBRILLATION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
Congenital, familial and genetic disorders             
TRACHEO-OESOPHAGEAL FISTULA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ICHTHYOSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Ear and labyrinth disorders             
VERTIGO † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Endocrine disorders             
HYPOPITUITARISM † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPOPHYSITIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Eye disorders             
OPTIC ISCHAEMIC NEUROPATHY † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
MACULAR CYST † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Gastrointestinal disorders             
NAUSEA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   2/65 (3.08%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
COLITIS † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
CONSTIPATION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
DYSPHAGIA † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
VOMITING † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   2/65 (3.08%)   0/42 (0.00%)   0/42 (0.00%)   2/44 (4.55%) 
GASTROOESOPHAGEAL REFLUX DISEASE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ILEAL PERFORATION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
SALIVARY GLAND CALCULUS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
ABDOMINAL DISTENSION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
DIARRHOEA † 1             
# participants affected / at risk   7/71 (9.86%)   5/67 (7.46%)   4/65 (6.15%)   1/42 (2.38%)   2/42 (4.76%)   1/44 (2.27%) 
DUODENAL ULCER † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ENTERITIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
GASTROINTESTINAL PERFORATION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
OESOPHAGEAL DISORDER † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PANCREATITIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
ABDOMINAL HERNIA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
EROSIVE OESOPHAGITIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
GASTRITIS EROSIVE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
RECTAL HAEMORRHAGE † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
General disorders             
GENERAL PHYSICAL HEALTH DETERIORATION † 1             
# participants affected / at risk   2/71 (2.82%)   1/67 (1.49%)   0/65 (0.00%)   2/42 (4.76%)   0/42 (0.00%)   0/44 (0.00%) 
MULTI-ORGAN FAILURE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
PYREXIA † 1             
# participants affected / at risk   1/71 (1.41%)   3/67 (4.48%)   0/65 (0.00%)   4/42 (9.52%)   0/42 (0.00%)   0/44 (0.00%) 
ASTHENIA † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   1/65 (1.54%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
OEDEMA PERIPHERAL † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CHEST PAIN † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
PAIN † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
DEATH † 1             
# participants affected / at risk   2/71 (2.82%)   4/67 (5.97%)   2/65 (3.08%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
FATIGUE † 1             
# participants affected / at risk   1/71 (1.41%)   2/67 (2.99%)   1/65 (1.54%)   1/42 (2.38%)   1/42 (2.38%)   1/44 (2.27%) 
LOCALISED OEDEMA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
SUDDEN DEATH † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
DISEASE PROGRESSION † 1             
# participants affected / at risk   5/71 (7.04%)   1/67 (1.49%)   4/65 (6.15%)   1/42 (2.38%)   0/42 (0.00%)   1/44 (2.27%) 
DROWNING † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Hepatobiliary disorders             
AUTOIMMUNE HEPATITIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HEPATITIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
HEPATITIS ACUTE † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
BILIARY COLIC † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HEPATOTOXICITY † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
BILE DUCT STENOSIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Immune system disorders             
HYPERSENSITIVITY † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ANAPHYLACTIC REACTION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Infections and infestations             
GASTROENTERITIS SHIGELLA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
SEPSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   1/42 (2.38%)   1/44 (2.27%) 
SIALOADENITIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
URINARY TRACT INFECTION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ERYSIPELAS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
GASTROENTERITIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CELLULITIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
FEBRILE INFECTION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
GASTROINTESTINAL INFECTION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
PSEUDOMONAL SEPSIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
BRONCHITIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CLOSTRIDIUM DIFFICILE COLITIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
SEPTIC SHOCK † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
MENINGITIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
LOBAR PNEUMONIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PLEURAL INFECTION BACTERIAL † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PNEUMONIA † 1             
# participants affected / at risk   5/71 (7.04%)   2/67 (2.99%)   2/65 (3.08%)   0/42 (0.00%)   0/42 (0.00%)   2/44 (4.55%) 
Injury, poisoning and procedural complications             
UPPER LIMB FRACTURE † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
FEMUR FRACTURE † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PROCEDURAL PAIN † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HIP FRACTURE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Investigations             
ALANINE AMINOTRANSFERASE INCREASED † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   2/42 (4.76%)   1/42 (2.38%)   0/44 (0.00%) 
WEIGHT DECREASED † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   2/42 (4.76%)   1/42 (2.38%)   0/44 (0.00%) 
HEPATIC ENZYME INCREASED † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
Metabolism and nutrition disorders             
METABOLIC ACIDOSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
DEHYDRATION † 1             
# participants affected / at risk   2/71 (2.82%)   2/67 (2.99%)   4/65 (6.15%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CACHEXIA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HYPERGLYCAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPERCALCAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
MALNUTRITION † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPOKALAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
ACIDOSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPOCALCAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPONATRAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Musculoskeletal and connective tissue disorders             
MUSCULAR WEAKNESS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   3/65 (4.62%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PAIN IN EXTREMITY † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PATHOLOGICAL FRACTURE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
MALIGNANT PLEURAL EFFUSION † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
METASTATIC NEOPLASM † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
TUMOUR PAIN † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
LUNG NEOPLASM † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
MALIGNANT NEOPLASM PROGRESSION † 1             
# participants affected / at risk   2/71 (2.82%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PERICARDIAL EFFUSION MALIGNANT † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
LUNG CANCER METASTATIC † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
NEOPLASM PROGRESSION † 1             
# participants affected / at risk   3/71 (4.23%)   1/67 (1.49%)   3/65 (4.62%)   4/42 (9.52%)   2/42 (4.76%)   3/44 (6.82%) 
NON-SMALL CELL LUNG CANCER † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
SQUAMOUS CELL CARCINOMA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
LUNG NEOPLASM MALIGNANT † 1             
# participants affected / at risk   4/71 (5.63%)   4/67 (5.97%)   5/65 (7.69%)   4/42 (9.52%)   6/42 (14.29%)   5/44 (11.36%) 
Nervous system disorders             
SYNCOPE † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
CEREBRAL HAEMORRHAGE † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
DYSARTHRIA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HEADACHE † 1             
# participants affected / at risk   0/71 (0.00%)   2/67 (2.99%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYDROCEPHALUS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
ATAXIA † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
EPILEPSY † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CERVICAL CORD COMPRESSION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CONVULSION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   1/42 (2.38%)   0/42 (0.00%)   1/44 (2.27%) 
GRAND MAL CONVULSION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PERIPHERAL SENSORIMOTOR NEUROPATHY † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
BASAL GANGLIA HAEMORRHAGE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
MONOPLEGIA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
NEUROPATHY PERIPHERAL † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PERIPHERAL MOTOR NEUROPATHY † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PERIPHERAL SENSORY NEUROPATHY † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
OCCIPITAL NEURALGIA † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Psychiatric disorders             
CONFUSIONAL STATE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Renal and urinary disorders             
RENAL FAILURE ACUTE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
ACUTE RESPIRATORY FAILURE † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PLEURAL EFFUSION † 1             
# participants affected / at risk   3/71 (4.23%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
PNEUMOTHORAX † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
PULMONARY EMBOLISM † 1             
# participants affected / at risk   4/71 (5.63%)   2/67 (2.99%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
BRONCHITIS CHRONIC † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
BRONCHOSPASM † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
OBSTRUCTIVE AIRWAYS DISORDER † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HAEMOPTYSIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
PNEUMONIA ASPIRATION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
MEDIASTINAL DISORDER † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
PULMONARY HAEMORRHAGE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   3/65 (4.62%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
DYSPNOEA † 1             
# participants affected / at risk   4/71 (5.63%)   2/67 (2.99%)   2/65 (3.08%)   2/42 (4.76%)   1/42 (2.38%)   1/44 (2.27%) 
LUNG DISORDER † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Skin and subcutaneous tissue disorders             
ERYTHEMA MULTIFORME † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
RASH † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   1/65 (1.54%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
RASH MACULAR † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
TOXIC EPIDERMAL NECROLYSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   1/44 (2.27%) 
DERMATITIS EXFOLIATIVE † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   1/42 (2.38%)   0/42 (0.00%)   0/44 (0.00%) 
Vascular disorders             
ARTERIAL THROMBOSIS † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   1/42 (2.38%)   0/44 (0.00%) 
HYPOTENSION † 1             
# participants affected / at risk   1/71 (1.41%)   1/67 (1.49%)   2/65 (3.08%)   1/42 (2.38%)   0/42 (0.00%)   1/44 (2.27%) 
PERIPHERAL ISCHAEMIA † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
THROMBOPHLEBITIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
DEEP VEIN THROMBOSIS † 1             
# participants affected / at risk   1/71 (1.41%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
VENOUS THROMBOSIS † 1             
# participants affected / at risk   0/71 (0.00%)   1/67 (1.49%)   0/65 (0.00%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
HYPERTENSION † 1             
# participants affected / at risk   0/71 (0.00%)   0/67 (0.00%)   1/65 (1.54%)   0/42 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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