Checkmate 171: An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02409368
Collaborator
PPD (Industry)
810
79
1
76
10.3
0.1
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
810 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Actual Study Start Date
:
Apr 29, 2015
Actual Primary Completion Date
:
Mar 7, 2018
Actual Study Completion Date
:
Aug 27, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A: Treatment - Nivolumab Nivolumab IV infusion |
Drug: Nivolumab
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
The total number of participants with high grade treatment related select adverse events.
Secondary Outcome Measures
- Number of Participants With High Grade Select Adverse Events [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
The total number of participants with high grade select adverse events.
- Median Time to Onset of Any Grade Select Adverse Events [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
Median Time to onset of any grade select adverse events reported up to 30 days after last dose
- Median Time to Resolution of Any Grade Select Adverse Events [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
Median time to resolution of any grade select adverse events reported up to 30 days after last dose
- Overall Survival [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
OS is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
- Objective Response Rate (ORR) [From first dose to time of analysis of primary endpoint (approximately up to 34 months)]
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed CR or PR with respect to all treated participants. ORR as assessed by the investigator will be reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-
ECOG Status: PS 0-1 & PS 2
-
Subjects with histologically or cytologically-documented SqNSCLC
-
Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
-
Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
-
Subjects with treated or asymptomatic CNS metastases
-
Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
-
Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
-
Males and Females, ages 18 or older
Exclusion Criteria:
-
Subjects with untreated, symptomatic CNS metastases
-
Subjects with carcinomatous meningitis
-
Subjects with active, known or suspected autoimmune disease.
-
Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Salzburg | Austria | 5020 | |
| 2 | Local Institution | Wels | Austria | 4600 | |
| 3 | Local Institution | Wien | Austria | 1140 | |
| 4 | Local Institution | Aalborg | Denmark | 9000 | |
| 5 | Local Institution | Herlev | Denmark | 2730 | |
| 6 | Local Institution | Odense C | Denmark | 5000 | |
| 7 | Local Institution | Oulu | Finland | 90220 | |
| 8 | Local Institution | Pori | Finland | FI-28500 | |
| 9 | Local Institution | Athens | Greece | 11527 | |
| 10 | Local Institution | Athens | Greece | 145 64 | |
| 11 | Local Institution | Heraklion | Greece | 71110 | |
| 12 | Local Institution | Patras | Greece | 26504 | |
| 13 | Local Institution | Thessaloniki | Greece | 57010 | |
| 14 | Local Institution | Budapest | Hungary | 1121 | |
| 15 | Local Institution | Debrecen | Hungary | 4032 | |
| 16 | Local Institution | Pécs | Hungary | 7624 | |
| 17 | Local Institution | Dublin 8 | Dublin | Ireland | |
| 18 | Local Institution | Galway | Ireland | ST4 6QG | |
| 19 | Local Institution | Gdansk | Poland | 80-214 | |
| 20 | Local Institution | Gliwice | Poland | 44-101 | |
| 21 | Instytut Medyczny Santa Familia Sp. z o.o. | Lodz | Poland | 90-302 | |
| 22 | Local Institution | Poznan | Poland | 60-693 | |
| 23 | Local Institution | Warszawa | Poland | 04-141 | |
| 24 | Local Institution | Zabrze | Poland | 41-803 | |
| 25 | Local Institution | Coimbra | Portugal | 3000-602 | |
| 26 | Local Institution | Lisboa | Portugal | 1099-023 | |
| 27 | Local Institution | Lisboa | Portugal | 1769-001 | |
| 28 | Local Institution | Porto | Portugal | 4099-001 | |
| 29 | Local Institution | Porto | Portugal | 4200-072 | |
| 30 | Local Institution | Porto | Portugal | 4200-319 | |
| 31 | Local Institution | Bucharest | Romania | 022328 | |
| 32 | Local Institution | Bucharest | Romania | 030171 | |
| 33 | Local Institution | Cluj Napoca | Romania | 400015 | |
| 34 | Local Institution | Cluj-Napoca | Romania | 400058 | |
| 35 | Local Institution | Oradea | Romania | 410469 | |
| 36 | Local Institution | Timisoara | Romania | 300167 | |
| 37 | Local Institution | Moscow | Russian Federation | 115478 | |
| 38 | Local Institution | Saint Petersburg | Russian Federation | 197758 | |
| 39 | Local Institution | St. Petersburg | Russian Federation | 198255 | |
| 40 | Local Institution | A Coruna | Spain | 15006 | |
| 41 | Local Institution | Alicante | Spain | 03010 | |
| 42 | Local Institution | Barcelona | Spain | 08025 | |
| 43 | Local Institution | Barcelona | Spain | 08035 | |
| 44 | Local Institution | Barcelona | Spain | 08036 | |
| 45 | Local Institution | Barcelona | Spain | 8916 | |
| 46 | Local Institution | Burgos | Spain | 09006 | |
| 47 | Local Institution | Granada | Spain | 18014 | |
| 48 | Local Institution | La Laguna | Spain | 38320 | |
| 49 | Local Institution | Madrid | Spain | 28034 | |
| 50 | Local Institution | Madrid | Spain | 28040 | |
| 51 | Local Institution | Madrid | Spain | 28041 | |
| 52 | Local Institution | Madrid | Spain | 28046 | |
| 53 | Local Institution | Malaga | Spain | 29010 | |
| 54 | Local Institution | Palma de Mallorca | Spain | 07198 | |
| 55 | Local Institution | Santander | Spain | 39008 | |
| 56 | Local Institution | Seville | Spain | 41013 | |
| 57 | Local Institution | Valencia | Spain | 46010 | |
| 58 | Local Institution | Valencia | Spain | 46026 | |
| 59 | Local Institution | Zaragoza | Spain | 50009 | |
| 60 | Local Institution | Goteborg | Sweden | 413 45 | |
| 61 | Local Institution | Stockholm | Sweden | 171 76 | |
| 62 | Local Institution | Plymouth | Devon | United Kingdom | PL6 8DH |
| 63 | North Middlesex Hospital | London | Greater London | United Kingdom | N18 1QX |
| 64 | Local Institution | London | Greater London | United Kingdom | SW3 6JJ |
| 65 | Local Institution | Manchester | Greater Manchester | United Kingdom | M20 4BX |
| 66 | Maidstone Hospital | Maidstone | Kent | United Kingdom | ME16 9QQ |
| 67 | Local Institution | Sutton | Surrey | United Kingdom | SM2 5PT |
| 68 | Local Institution | Bebington | United Kingdom | CH63 4JY | |
| 69 | Local Institution | Bristol | United Kingdom | BS2 8ED | |
| 70 | Local Institution | Cardiff | United Kingdom | CF14 2TL | |
| 71 | Local Institution | Cottingham | United Kingdom | HU16 5JQ | |
| 72 | Local Institution | Glasgow | United Kingdom | G12 OYN | |
| 73 | Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
| 74 | Local Institution | London | United Kingdom | W1T 7HA | |
| 75 | Local Institution | London | United Kingdom | W6 8RF | |
| 76 | Local Institution | Northwood | United Kingdom | HA6 2RN | |
| 77 | Royal Preston Hospital | Preston | United Kingdom | PR2 9HT | |
| 78 | Local Institution | Sheffield | United Kingdom | S10 5SJ | |
| 79 | Southampton University Hospitals NHS Trust | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Bristol-Myers Squibb
- PPD
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02409368
Other Study ID Numbers:
- CA209-171
- 2014-001285-10
First Posted:
Apr 6, 2015
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 810 participants enrolled and treated |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Period Title: Overall Study | |||
| STARTED | 173 | 534 | 103 |
| COMPLETED | 25 | 45 | 4 |
| NOT COMPLETED | 148 | 489 | 99 |
Baseline Characteristics
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) | Total |
|---|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | Total of all reporting groups |
| Overall Participants | 173 | 534 | 103 | 810 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
63.7
(8.31)
|
66.1
(8.28)
|
67.8
(7.25)
|
65.8
(8.24)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
37
21.4%
|
111
20.8%
|
22
21.4%
|
170
21%
|
| Male |
136
78.6%
|
423
79.2%
|
81
78.6%
|
640
79%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
13
7.5%
|
37
6.9%
|
11
10.7%
|
61
7.5%
|
| Not Hispanic or Latino |
160
92.5%
|
497
93.1%
|
92
89.3%
|
749
92.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
2
0.4%
|
0
0%
|
2
0.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
3
0.6%
|
0
0%
|
3
0.4%
|
| White |
166
96%
|
527
98.7%
|
103
100%
|
796
98.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
7
4%
|
2
0.4%
|
0
0%
|
9
1.1%
|
Outcome Measures
| Title | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events |
|---|---|
| Description | The total number of participants with high grade treatment related select adverse events. |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Treated participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 173 | 534 | 103 |
| Skin |
1
0.6%
|
7
1.3%
|
0
0%
|
| Gastrointestinal |
1
0.6%
|
10
1.9%
|
0
0%
|
| Endocrine |
4
2.3%
|
3
0.6%
|
0
0%
|
| Hepatic |
3
1.7%
|
11
2.1%
|
2
1.9%
|
| Pulmonary |
2
1.2%
|
5
0.9%
|
0
0%
|
| Renal |
0
0%
|
3
0.6%
|
1
1%
|
| Hypersensitivity/ Infusion reaction |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With High Grade Select Adverse Events |
|---|---|
| Description | The total number of participants with high grade select adverse events. |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Treated participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 173 | 534 | 103 |
| Skin |
1
0.6%
|
7
1.3%
|
0
0%
|
| Gastrointestinal |
1
0.6%
|
11
2.1%
|
0
0%
|
| Endocrine |
5
2.9%
|
4
0.7%
|
0
0%
|
| Hepatic |
5
2.9%
|
17
3.2%
|
3
2.9%
|
| Pulmonary |
0
0%
|
7
1.3%
|
1
1%
|
| Renal |
3
1.7%
|
8
1.5%
|
1
1%
|
| Hypersensitivity/ Infusion reaction |
0
0%
|
0
0%
|
1
1%
|
| Title | Median Time to Onset of Any Grade Select Adverse Events |
|---|---|
| Description | Median Time to onset of any grade select adverse events reported up to 30 days after last dose |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Treated Participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 173 | 534 | 103 |
| Endrocrine |
12.00
|
10.14
|
13.86
|
| Gastrointestinal |
11.71
|
8.50
|
6.00
|
| Hepatic |
19.14
|
10.43
|
7.21
|
| Pulmonary |
32.93
|
10.57
|
3.93
|
| Renal |
28.14
|
17.43
|
10.29
|
| Skin |
17.07
|
7.86
|
12.64
|
| Hypersensitivity/Infusion Reaction |
2.14
|
2.21
|
2.14
|
| Title | Median Time to Resolution of Any Grade Select Adverse Events |
|---|---|
| Description | Median time to resolution of any grade select adverse events reported up to 30 days after last dose |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Treated Participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 173 | 534 | 103 |
| Endrocrine |
NA
|
NA
|
NA
|
| Gastrointestinal |
2.79
|
3.71
|
1.29
|
| Hepatic |
4.43
|
4.86
|
3.57
|
| Pulmonary |
3.00
|
4.00
|
NA
|
| Renal |
10.14
|
6.000
|
59.1
|
| Skin |
17.00
|
15.29
|
5.71
|
| Hypersensitivity/Infusion Reaction |
0.14
|
0.14
|
0.14
|
| Title | Overall Survival |
|---|---|
| Description | OS is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug. |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Treated Participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 108 | 376 | 84 |
| Median (95% Confidence Interval) [Months] |
12.1
|
10.3
|
5.2
|
| Title | Objective Response Rate (ORR) |
|---|---|
| Description | ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed CR or PR with respect to all treated participants. ORR as assessed by the investigator will be reported. |
| Time Frame | From first dose to time of analysis of primary endpoint (approximately up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Response Evaluable Participants |
| Arm/Group Title | ECOG (PS0) | ECOG (PS1) | ECOG (PS 2) |
|---|---|---|---|
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks |
| Measure Participants | 151 | 455 | 64 |
| Number (95% Confidence Interval) [Percentage] |
7.9
|
11.6
|
1.6
|
Adverse Events
| Time Frame | approximately 39 months | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | ECOG PS 0 | ECOG PS 1 | ECOG PS 2 | Total | ||||
| Arm/Group Description | ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ECOG Performance Status 2 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | Total nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | ||||
All Cause Mortality |
||||||||
| ECOG PS 0 | ECOG PS 1 | ECOG PS 2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 108/173 (62.4%) | 376/534 (70.4%) | 84/103 (81.6%) | 568/810 (70.1%) | ||||
Serious Adverse Events |
||||||||
| ECOG PS 0 | ECOG PS 1 | ECOG PS 2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 93/173 (53.8%) | 297/534 (55.6%) | 71/103 (68.9%) | 461/810 (56.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 2/173 (1.2%) | 6/534 (1.1%) | 1/103 (1%) | 9/810 (1.1%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 2/173 (1.2%) | 2/534 (0.4%) | 1/103 (1%) | 5/810 (0.6%) | ||||
| Atrial flutter | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cardiac arrest | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cardiac failure | 1/173 (0.6%) | 3/534 (0.6%) | 0/103 (0%) | 4/810 (0.5%) | ||||
| Cardiac failure congestive | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cardiac tamponade | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Cardiac ventricular thrombosis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cardio-respiratory arrest | 1/173 (0.6%) | 1/534 (0.2%) | 1/103 (1%) | 3/810 (0.4%) | ||||
| Cardiomegaly | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Left ventricular failure | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Myocardial infarction | 2/173 (1.2%) | 3/534 (0.6%) | 1/103 (1%) | 6/810 (0.7%) | ||||
| Pericardial effusion | 1/173 (0.6%) | 2/534 (0.4%) | 1/103 (1%) | 4/810 (0.5%) | ||||
| Pericarditis | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Supraventricular extrasystoles | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Tracheo-oesophageal fistula | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Endocrine disorders | ||||||||
| Adrenal insufficiency | 2/173 (1.2%) | 1/534 (0.2%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Hypercalcaemia of malignancy | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hyperthyroidism | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypophysitis | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypothyroidism | 2/173 (1.2%) | 2/534 (0.4%) | 0/103 (0%) | 4/810 (0.5%) | ||||
| Thyroiditis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Anal fissure | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Ascites | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Colitis | 0/173 (0%) | 5/534 (0.9%) | 0/103 (0%) | 5/810 (0.6%) | ||||
| Constipation | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Diarrhoea | 0/173 (0%) | 6/534 (1.1%) | 1/103 (1%) | 7/810 (0.9%) | ||||
| Dysphagia | 0/173 (0%) | 4/534 (0.7%) | 1/103 (1%) | 5/810 (0.6%) | ||||
| Gastric ulcer | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Gastritis | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Gastrointestinal disorder | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Gastrooesophageal reflux disease | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Inguinal hernia | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Intestinal obstruction | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Large intestinal obstruction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Oesophageal stenosis | 1/173 (0.6%) | 2/534 (0.4%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Stomatitis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Upper gastrointestinal haemorrhage | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Vomiting | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| General disorders | ||||||||
| Asthenia | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Chest pain | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Death | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Disease progression | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Fatigue | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| General physical health deterioration | 1/173 (0.6%) | 1/534 (0.2%) | 1/103 (1%) | 3/810 (0.4%) | ||||
| Hernia obstructive | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Non-cardiac chest pain | 1/173 (0.6%) | 4/534 (0.7%) | 1/103 (1%) | 6/810 (0.7%) | ||||
| Oedema peripheral | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Pain | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pyrexia | 0/173 (0%) | 5/534 (0.9%) | 0/103 (0%) | 5/810 (0.6%) | ||||
| Sudden cardiac death | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Sudden death | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Systemic inflammatory response syndrome | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hepatobiliary disorders | ||||||||
| Autoimmune hepatitis | 0/173 (0%) | 2/534 (0.4%) | 2/103 (1.9%) | 4/810 (0.5%) | ||||
| Cholangitis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Drug-induced liver injury | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hepatic failure | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Jaundice | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Jaundice cholestatic | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Liver injury | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Infections and infestations | ||||||||
| Abscess jaw | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Anal abscess | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Bacteraemia | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Bacterial diarrhoea | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Bronchitis | 4/173 (2.3%) | 8/534 (1.5%) | 1/103 (1%) | 13/810 (1.6%) | ||||
| Bronchitis bacterial | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Clostridium colitis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cystitis | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| H1N1 influenza | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Infection | 1/173 (0.6%) | 2/534 (0.4%) | 1/103 (1%) | 4/810 (0.5%) | ||||
| Infective exacerbation of chronic obstructive airways disease | 0/173 (0%) | 3/534 (0.6%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Lower respiratory tract infection | 4/173 (2.3%) | 15/534 (2.8%) | 4/103 (3.9%) | 23/810 (2.8%) | ||||
| Lung infection | 5/173 (2.9%) | 2/534 (0.4%) | 3/103 (2.9%) | 10/810 (1.2%) | ||||
| Mediastinitis | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Meningitis aseptic | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Parainfluenzae virus infection | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pneumonia | 13/173 (7.5%) | 24/534 (4.5%) | 7/103 (6.8%) | 44/810 (5.4%) | ||||
| Pneumonia bacterial | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pneumonia pneumococcal | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pulmonary sepsis | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Pulmonary tuberculosis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Respiratory tract infection | 10/173 (5.8%) | 24/534 (4.5%) | 5/103 (4.9%) | 39/810 (4.8%) | ||||
| Sepsis | 3/173 (1.7%) | 5/534 (0.9%) | 0/103 (0%) | 8/810 (1%) | ||||
| Septic shock | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Streptococcal infection | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Tracheobronchitis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Upper respiratory tract infection | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Urinary tract infection | 1/173 (0.6%) | 4/534 (0.7%) | 1/103 (1%) | 6/810 (0.7%) | ||||
| Vulval abscess | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Concussion | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Fall | 0/173 (0%) | 0/534 (0%) | 2/103 (1.9%) | 2/810 (0.2%) | ||||
| Hip fracture | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Humerus fracture | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Infusion related reaction | 1/173 (0.6%) | 1/534 (0.2%) | 1/103 (1%) | 3/810 (0.4%) | ||||
| Intentional overdose | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Overdose | 0/173 (0%) | 0/534 (0%) | 2/103 (1.9%) | 2/810 (0.2%) | ||||
| Rib fracture | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Skull fractured base | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Spinal compression fracture | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Splenic rupture | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Tracheal obstruction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Upper limb fracture | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Aspartate aminotransferase increased | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Liver function test increased | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 2/173 (1.2%) | 2/534 (0.4%) | 1/103 (1%) | 5/810 (0.6%) | ||||
| Diabetes mellitus | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypercalcaemia | 0/173 (0%) | 12/534 (2.2%) | 3/103 (2.9%) | 15/810 (1.9%) | ||||
| Hyperglycaemia | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Hyperkalaemia | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypoglycaemia | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypokalaemia | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hyponatraemia | 2/173 (1.2%) | 3/534 (0.6%) | 2/103 (1.9%) | 7/810 (0.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthritis | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Back pain | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Bone disorder | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Muscular weakness | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Musculoskeletal chest pain | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Pain in extremity | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Patellofemoral pain syndrome | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pathological fracture | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Spinal pain | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Bladder cancer | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Brain cancer metastatic | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cancer pain | 1/173 (0.6%) | 1/534 (0.2%) | 1/103 (1%) | 3/810 (0.4%) | ||||
| Colon cancer | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Follicular thyroid cancer | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Lung neoplasm malignant | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Malignant neoplasm progression | 24/173 (13.9%) | 94/534 (17.6%) | 34/103 (33%) | 152/810 (18.8%) | ||||
| Metastases to bone | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Metastases to central nervous system | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Metastases to lymph nodes | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Metastasis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Neoplasm progression | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Non-small cell lung cancer metastatic | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Pancreatic carcinoma | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Small intestine adenocarcinoma | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Tumour associated fever | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Tumour compression | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Tumour pain | 1/173 (0.6%) | 4/534 (0.7%) | 2/103 (1.9%) | 7/810 (0.9%) | ||||
| Nervous system disorders | ||||||||
| Brain oedema | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cerebral infarction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Cerebrovascular accident | 1/173 (0.6%) | 1/534 (0.2%) | 1/103 (1%) | 3/810 (0.4%) | ||||
| Dizziness | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Epilepsy | 1/173 (0.6%) | 2/534 (0.4%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Intracranial pressure increased | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Lacunar infarction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Loss of consciousness | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Monoparesis | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Motor dysfunction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Neuropathy peripheral | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Peripheral sensory neuropathy | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Seizure | 1/173 (0.6%) | 3/534 (0.6%) | 0/103 (0%) | 4/810 (0.5%) | ||||
| Spinal cord compression | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Status epilepticus | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Syncope | 0/173 (0%) | 0/534 (0%) | 3/103 (2.9%) | 3/810 (0.4%) | ||||
| Transient ischaemic attack | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Tremor | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Psychiatric disorders | ||||||||
| Agitation | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Confusional state | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Delirium | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/173 (0%) | 4/534 (0.7%) | 1/103 (1%) | 5/810 (0.6%) | ||||
| Calculus urinary | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Haematuria | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Leukocyturia | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Nephrolithiasis | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Renal failure | 0/173 (0%) | 4/534 (0.7%) | 0/103 (0%) | 4/810 (0.5%) | ||||
| Urinary retention | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Urinary tract obstruction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute respiratory failure | 0/173 (0%) | 2/534 (0.4%) | 2/103 (1.9%) | 4/810 (0.5%) | ||||
| Asthma | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Atelectasis | 2/173 (1.2%) | 0/534 (0%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Bronchial obstruction | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Bronchopneumopathy | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Chronic obstructive pulmonary disease | 1/173 (0.6%) | 5/534 (0.9%) | 4/103 (3.9%) | 10/810 (1.2%) | ||||
| Dyspnoea | 7/173 (4%) | 24/534 (4.5%) | 9/103 (8.7%) | 40/810 (4.9%) | ||||
| Epistaxis | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Haemoptysis | 7/173 (4%) | 12/534 (2.2%) | 3/103 (2.9%) | 22/810 (2.7%) | ||||
| Hypoxia | 0/173 (0%) | 2/534 (0.4%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Interstitial lung disease | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Lung consolidation | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Oesophagobronchial fistula | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pleural effusion | 3/173 (1.7%) | 7/534 (1.3%) | 1/103 (1%) | 11/810 (1.4%) | ||||
| Pneumonia aspiration | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Pneumonitis | 3/173 (1.7%) | 13/534 (2.4%) | 0/103 (0%) | 16/810 (2%) | ||||
| Pneumothorax | 0/173 (0%) | 3/534 (0.6%) | 1/103 (1%) | 4/810 (0.5%) | ||||
| Pulmonary embolism | 2/173 (1.2%) | 4/534 (0.7%) | 0/103 (0%) | 6/810 (0.7%) | ||||
| Pulmonary haemorrhage | 1/173 (0.6%) | 2/534 (0.4%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Respiratory failure | 3/173 (1.7%) | 8/534 (1.5%) | 1/103 (1%) | 12/810 (1.5%) | ||||
| Respiratory tract haemorrhage | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Angioedema | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 0/173 (0%) | 0/534 (0%) | 1/103 (1%) | 1/810 (0.1%) | ||||
| Embolism | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypertension | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Hypotension | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Peripheral ischaemia | 0/173 (0%) | 1/534 (0.2%) | 0/103 (0%) | 1/810 (0.1%) | ||||
| Superior vena cava occlusion | 1/173 (0.6%) | 1/534 (0.2%) | 0/103 (0%) | 2/810 (0.2%) | ||||
| Superior vena cava syndrome | 0/173 (0%) | 3/534 (0.6%) | 0/103 (0%) | 3/810 (0.4%) | ||||
| Thrombosis | 1/173 (0.6%) | 0/534 (0%) | 0/103 (0%) | 1/810 (0.1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| ECOG PS 0 | ECOG PS 1 | ECOG PS 2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 142/173 (82.1%) | 459/534 (86%) | 86/103 (83.5%) | 687/810 (84.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 23/173 (13.3%) | 96/534 (18%) | 20/103 (19.4%) | 139/810 (17.2%) | ||||
| Endocrine disorders | ||||||||
| Hypothyroidism | 22/173 (12.7%) | 32/534 (6%) | 5/103 (4.9%) | 59/810 (7.3%) | ||||
| Hyperthyroidism | 13/173 (7.5%) | 16/534 (3%) | 1/103 (1%) | 30/810 (3.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Constipation | 15/173 (8.7%) | 70/534 (13.1%) | 15/103 (14.6%) | 100/810 (12.3%) | ||||
| Diarrhoea | 25/173 (14.5%) | 94/534 (17.6%) | 16/103 (15.5%) | 135/810 (16.7%) | ||||
| Nausea | 19/173 (11%) | 66/534 (12.4%) | 15/103 (14.6%) | 100/810 (12.3%) | ||||
| Vomiting | 9/173 (5.2%) | 31/534 (5.8%) | 9/103 (8.7%) | 49/810 (6%) | ||||
| Stomatitis | 4/173 (2.3%) | 13/534 (2.4%) | 7/103 (6.8%) | 24/810 (3%) | ||||
| General disorders | ||||||||
| Asthenia | 28/173 (16.2%) | 128/534 (24%) | 15/103 (14.6%) | 171/810 (21.1%) | ||||
| Fatigue | 40/173 (23.1%) | 119/534 (22.3%) | 22/103 (21.4%) | 181/810 (22.3%) | ||||
| Oedema peripheral | 6/173 (3.5%) | 24/534 (4.5%) | 12/103 (11.7%) | 42/810 (5.2%) | ||||
| Pyrexia | 8/173 (4.6%) | 48/534 (9%) | 6/103 (5.8%) | 62/810 (7.7%) | ||||
| Chest pain | 9/173 (5.2%) | 25/534 (4.7%) | 2/103 (1.9%) | 36/810 (4.4%) | ||||
| Non-cardiac chest pain | 4/173 (2.3%) | 23/534 (4.3%) | 6/103 (5.8%) | 33/810 (4.1%) | ||||
| Infections and infestations | ||||||||
| Lower respiratory tract infection | 17/173 (9.8%) | 48/534 (9%) | 6/103 (5.8%) | 71/810 (8.8%) | ||||
| Respiratory tract infection | 9/173 (5.2%) | 37/534 (6.9%) | 6/103 (5.8%) | 52/810 (6.4%) | ||||
| Nasopharyngitis | 11/173 (6.4%) | 14/534 (2.6%) | 1/103 (1%) | 26/810 (3.2%) | ||||
| Upper respiratory tract infection | 10/173 (5.8%) | 21/534 (3.9%) | 2/103 (1.9%) | 33/810 (4.1%) | ||||
| Investigations | ||||||||
| Aspartate aminotransferase increased | 12/173 (6.9%) | 26/534 (4.9%) | 5/103 (4.9%) | 43/810 (5.3%) | ||||
| Weight decreased | 7/173 (4%) | 39/534 (7.3%) | 7/103 (6.8%) | 53/810 (6.5%) | ||||
| Alanine aminotransferase increased | 9/173 (5.2%) | 25/534 (4.7%) | 4/103 (3.9%) | 38/810 (4.7%) | ||||
| Blood creatinine increased | 6/173 (3.5%) | 27/534 (5.1%) | 5/103 (4.9%) | 38/810 (4.7%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 23/173 (13.3%) | 136/534 (25.5%) | 21/103 (20.4%) | 180/810 (22.2%) | ||||
| Hypercalcaemia | 5/173 (2.9%) | 36/534 (6.7%) | 6/103 (5.8%) | 47/810 (5.8%) | ||||
| Hypomagnesaemia | 10/173 (5.8%) | 26/534 (4.9%) | 3/103 (2.9%) | 39/810 (4.8%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 14/173 (8.1%) | 37/534 (6.9%) | 5/103 (4.9%) | 56/810 (6.9%) | ||||
| Back pain | 11/173 (6.4%) | 39/534 (7.3%) | 7/103 (6.8%) | 57/810 (7%) | ||||
| Musculoskeletal chest pain | 6/173 (3.5%) | 24/534 (4.5%) | 7/103 (6.8%) | 37/810 (4.6%) | ||||
| Musculoskeletal pain | 9/173 (5.2%) | 21/534 (3.9%) | 3/103 (2.9%) | 33/810 (4.1%) | ||||
| Pain in extremity | 4/173 (2.3%) | 24/534 (4.5%) | 6/103 (5.8%) | 34/810 (4.2%) | ||||
| Nervous system disorders | ||||||||
| Headache | 9/173 (5.2%) | 33/534 (6.2%) | 3/103 (2.9%) | 45/810 (5.6%) | ||||
| Dizziness | 3/173 (1.7%) | 27/534 (5.1%) | 7/103 (6.8%) | 37/810 (4.6%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 42/173 (24.3%) | 129/534 (24.2%) | 18/103 (17.5%) | 189/810 (23.3%) | ||||
| Dyspnoea | 41/173 (23.7%) | 152/534 (28.5%) | 25/103 (24.3%) | 218/810 (26.9%) | ||||
| Haemoptysis | 12/173 (6.9%) | 44/534 (8.2%) | 9/103 (8.7%) | 65/810 (8%) | ||||
| Pneumonitis | 9/173 (5.2%) | 20/534 (3.7%) | 2/103 (1.9%) | 31/810 (3.8%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 7/173 (4%) | 38/534 (7.1%) | 9/103 (8.7%) | 54/810 (6.7%) | ||||
| Rash | 10/173 (5.8%) | 38/534 (7.1%) | 6/103 (5.8%) | 54/810 (6.7%) | ||||
| Dry skin | 7/173 (4%) | 25/534 (4.7%) | 6/103 (5.8%) | 38/810 (4.7%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 9/173 (5.2%) | 17/534 (3.2%) | 0/103 (0%) | 26/810 (3.2%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please Email |
| Clinical.Trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02409368
Other Study ID Numbers:
- CA209-171
- 2014-001285-10
First Posted:
Apr 6, 2015
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021