Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT01996332)

NCT ID: NCT01996332

Last Updated: 2014-07-10

Results Overview

Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1805 participants

Primary outcome timeframe

Baseline, every 6-8 weeks up to 3 years until disease progression or death

Results posted on

2014-07-10

Participant Flow

Three cohorts were established in participants with advanced non-small cell lung cancer (NSCLC) based on previous chemotherapy treatment received: first line of treatment (where conventional chemotherapy is not indicated), second line of treatment, and third and subsequent lines of treatment. Inclusion was competitive.

Participant milestones

Participant milestones
Measure	Erlotinib 150 Milligrams Per Day (mg/Day) Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
Overall Study STARTED	1805
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1805

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib 150 Milligrams Per Day (mg/Day) Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
Overall Study Adverse Event	117
Overall Study Lack of Efficacy	1245
Overall Study Death	264
Overall Study Protocol Violation	9
Overall Study Withdrawal by Subject	71
Overall Study Other	20
Overall Study Clinical Deterioration	28
Overall Study Physician Decision	17
Overall Study Lost to Follow-up	34

Baseline Characteristics

A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib 150 mg/Day n=1805 Participants Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Age, Continuous	63.55 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	520 Participants n=5 Participants
Sex: Female, Male Male	1285 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, every 6-8 weeks up to 3 years until disease progression or death

Population: ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line

Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg/Day n=1805 Participants Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Time to Disease Progression or Death by Line of Treatment 1st Line	3.4 months Interval 2.9 to 4.1
Time to Disease Progression or Death by Line of Treatment Maintenance after 1st Line	4.7 months Interval 3.0 to 6.6
Time to Disease Progression or Death by Line of Treatment 2nd Line	2.7 months Interval 2.5 to 2.9
Time to Disease Progression or Death by Line of Treatment Maintenance after 2nd Line	3.9 months Interval 1.2 to 6.8
Time to Disease Progression or Death by Line of Treatment 3rd or Subsequent Line	2.4 months Interval 2.2 to 2.7
Time to Disease Progression or Death by Line of Treatment Maintenance after 3rd Line	2.8 months Interval 1.8 to 5.0

SECONDARY outcome

Timeframe: Baseline, every 6-8 weeks up to 3 years or until death

Population: Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line

Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response \[CR\], partial response \[PR\], or stable disease \[SD\]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg/Day n=1261 Participants Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Percentage of Participants Achieving Clinical Benefit by Line of Treatment Maintenance treatment after 1st line	70.00 percentage of participants Interval 53.47 to 83.44
Percentage of Participants Achieving Clinical Benefit by Line of Treatment Maintenance treatment after 2nd line	73.68 percentage of participants Interval 48.8 to 90.85
Percentage of Participants Achieving Clinical Benefit by Line of Treatment 3rd or subsequent line	52.71 percentage of participants Interval 47.61 to 57.78
Percentage of Participants Achieving Clinical Benefit by Line of Treatment Maintenance treatment after 3rd line	50.00 percentage of participants Interval 15.7 to 84.3
Percentage of Participants Achieving Clinical Benefit by Line of Treatment 1st line	70.32 percentage of participants Interval 65.21 to 75.08
Percentage of Participants Achieving Clinical Benefit by Line of Treatment 2nd line	58.04 percentage of participants Interval 53.39 to 62.6

SECONDARY outcome

Timeframe: Baseline, every 6-8 weeks up to 3 years, or until death

Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date was unavailable\] minus the date of first dose of study medication plus 1 divided by 30.44).

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg/Day n=1805 Participants Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Overall Survival (OS) by Line of Treatment 1st Line	6.4 months Interval 5.8 to 7.4
Overall Survival (OS) by Line of Treatment Sequential treatment after 1st line	12.1 months Interval 6.2 to 19.3
Overall Survival (OS) by Line of Treatment 2nd Line	5.9 months Interval 5.2 to 6.4
Overall Survival (OS) by Line of Treatment Sequential treatment after 2nd line	7.1 months Interval 2.2 to 15.8
Overall Survival (OS) by Line of Treatment 3rd Line or subsequent	5.2 months Interval 4.3 to 6.1
Overall Survival (OS) by Line of Treatment Sequential treatment after 3rd line	3.9 months Interval 2.0 to 8.6

Adverse Events

Erlotinib 150 mg/Day

Serious events: 566 serious events

Other events: 1695 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib 150 mg/Day n=1797 participants at risk；n=1805 participants at risk Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobbin	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Neutrophils	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Platelets	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiac arrhythmia	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiac ischemia	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiopulmonary arrest	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypotension	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Left ventricular systolic dysfunction	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericardial effusion	0.39% 7/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericarditis	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Right ventricular dysfunction	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Alcohol Poisoning	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Asthenia	0.94% 17/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Constitutional symptoms/other	0.78% 14/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Social circumstances Drug abuser	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Fever	0.94% 17/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Social circumstances Opioid abuse	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Sweating	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Weight loss	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Dermatology/skin - other	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Rash	0.28% 5/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Anorexia	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Constipation	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Diarrhea	1.6% 28/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dyspepsia/heartburn	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dysphagia	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Esophagitis	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal/other	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ileus GI	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intestinal perforation	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Mucositis	0.28% 5/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Nausea	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Obstruction/GU	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Vomiting	0.39% 7/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.2% 21/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Hemorrhage	0.94% 17/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic cyst	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Liver dysfunction	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Febrile neutropenia	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Gallbladder infection	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection NOS	3.7% 67/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - anal/perianal	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - appendix	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - blood	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - brain (encephalitis, infectious)	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - bronchus	0.28% 5/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - catheter - related	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - kidney	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - liver	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - lung (pneumonia)	2.4% 44/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - skin (cellulitis)	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - soft tissue NOS	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - upper aerodigestive NOS	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - urinary tract NOS	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - wound	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Edema Limb	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Acidosis	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Bilirubin	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypercalcemia	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperglycemia	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyponatremia	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ascites	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Fracture	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Muscle weakness	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Musculoskeletal/other	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Trismus	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Ataxia	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders CNS ischemia	0.78% 14/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cognitive disturbance	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Confusion	0.61% 11/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Dizziness	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Encephalopathy	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Involuntary movement	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration - agitation	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration - anxiety	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Neurology/other	0.83% 15/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy/motor	0.39% 7/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy/sensory	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Psychosis	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Seizures	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Somnolence	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Speech impairment	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Syncope	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Diplopia	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Keratitis	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pain NOS	1.2% 22/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pain - abdominal NOS	0.39% 7/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - bone	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - chest wall	0.39% 7/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Pain - headache	0.28% 5/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - joint	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - limb	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pain - liver	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - muscle	0.83% 15/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Pain - neuralgia/peripheral nerve	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pain - pleura	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Airway obstruction/upper respiratory	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Cough	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.4% 188/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.50% 9/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.17% 3/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary/obstruction/stenosis of airway (bronchus)	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary/others	0.33% 6/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Obstruction/GI	0.22% 4/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure	0.55% 10/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Intraoperative complications	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Antiphospholipid syndrome	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Flu-like syndrome	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Ill-defined disorder	0.06% 1/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Syndromes/other-superior cava vein	0.50% 9/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Uncoded	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Phlebitis	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Thrombosis/embolism	1.4% 25/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vascular/other	0.11% 2/1805 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Other adverse events

Other adverse events
Measure	Erlotinib 150 mg/Day n=1797 participants at risk；n=1805 participants at risk Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Myositis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Trismus	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Dizziness	5.2% 94/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy/sensory	4.1% 74/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Ataxia	3.2% 57/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Confusion	3.1% 55/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neurology/other	2.9% 53/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration-anxiety	2.8% 51/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration-depression	2.5% 45/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy/motor	2.1% 38/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Somnolence	2.1% 38/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cognitive disturbance	1.6% 28/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Speech impairment	1.5% 27/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration-agitation	1.3% 23/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders CNS ischemia	0.89% 16/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Tremor	0.89% 16/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Syncope	0.83% 15/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Seizures	0.83% 15/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration	0.78% 14/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Memory impairment	0.61% 11/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Psychosis	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Involuntary movement	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Encephalopathy	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy cranial	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mood alteration-depression-anxiety	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Blurred vision	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Extrapyramidal disorder	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Seizure	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Edema limb	4.5% 80/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Edema	1.8% 33/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Edema head and neck	0.67% 12/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Lymphatic/other	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Bilirubin	1.3% 23/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperglycemia	0.95% 17/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations ALT	0.78% 14/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations AST	0.78% 14/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Alkaline phosphatase	0.61% 11/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypercalcemia	0.61% 11/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations GGT	0.56% 10/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperkalemia	0.50% 9/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypocalcemia	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyponatremia	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Metabolic lab/other	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperuricemia	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Hypercholesterolemia	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypoalbuminemia	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypokalemia	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypoglycemia	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Acidosis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Amylase	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypernatremia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations CPK	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypomagnesemia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypophosphatemia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Alkalosis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypertriglyceridemia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Musculoskeletal/other	4.3% 77/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Muscle weakness	1.3% 24/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Fracture	0.67% 12/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ascites	0.56% 10/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Gait	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Arthritis	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Rhinitis	0.78% 14/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Allergic reaction	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vasculitis	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Ear and labyrinth disorders Hearing	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Ear and labyrinth disorders Tinnitus	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Hemoglobin	5.0% 89/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Platelets	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Neutrophils	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Leucocytes	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Lymphopenia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Band neutrophil percentage increased	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiac arrhythmia	1.5% 27/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Vasovagal episodes	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Palpitations	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericardial effusion	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiac ischemia	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypotension	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiopulmonary arrest	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypertension	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Left ventricular systolic dysfunction	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Right ventricular dysfunction	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Valvular heart disease	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericarditis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Asthenia	36.2% 650/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Fever	11.7% 210/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Weight loss	5.1% 91/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Insomnia	3.7% 67/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Constitutional symptoms/other	2.3% 42/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Sweating	0.56% 10/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Mucosal dryness	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Pallor	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Inflammation	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Social circumstances Opioid abuse	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Rigors/chills	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Social circumstances Drug abuser	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Hypothermia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Weight gain	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Alcohol poisoning	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Rash	49.9% 897/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Dermatology/skin-other	17.1% 307/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Acne	8.5% 152/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Dry skin	7.6% 137/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Pruritus	5.3% 95/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Alopecia	5.1% 92/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Nail changes	4.0% 71/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Ulceration	0.83% 15/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Hand foot skin reaction	0.50% 9/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Flushing	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Burn	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Telangiectasia	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Endocrine disorders Cushingoid	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations ADH	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Glucose intolerance	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Diarrhea	35.1% 631/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Anorexia	25.7% 462/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Vomiting	11.4% 204/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Nausea	10.9% 196/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Mucositis	9.3% 167/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Constipation	6.1% 110/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dysphagia	2.7% 49/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dyspepsia/heartburn	2.2% 40/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Xerostomia	2.0% 36/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal/other	1.9% 35/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Dysgeusia	0.95% 17/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Hemorrhoids	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Incontinence, anal	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Distension	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Flatulence	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ileus GI	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Dehydration	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Esophagitis	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Enteritis	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intestinal perforation	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Taste Alteration (dysgeusia)	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Anal fistula	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Obstruction/GU	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Tooth disorder	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	9.3% 167/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Hemorrhage/GI	2.4% 43/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Hemorrhage/GU	0.78% 14/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Petechiae	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Hemorrhage/other	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Liver dysfunction	0.56% 10/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatobiliary/other	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholecystitis	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic cysts	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection NOS	8.2% 148/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - conjunctiva	6.0% 108/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - lung (pneumonia)	2.8% 51/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - ungual (nail)	2.8% 51/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - urinary tract nos	1.7% 31/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - skin (cellulitis)	1.6% 29/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - bronchus	1.0% 18/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - eye nos	0.95% 17/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - soft tissue nos	0.72% 13/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - upper aerodigestive nos	0.72% 13/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - pharynx	0.50% 9/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - blood	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - lip/perioral	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - anal/perianal	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - upper airway nos	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Tooth infection	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - vagina	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - auditory ear	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Febrile neutropenia	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Gallbladder infection	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - brain (encephalitis, infectious)	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - sinus	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - bone (osteomyelitis)	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - kidney	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - liver	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - salivary gland	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - dental-tooth	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - peritoneal cavity	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - wound	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - appendix	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - catheter-related	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - colon	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection - vulva	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Eye disorder	2.7% 48/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Watery eye	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Dry eye	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Diplopia	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Keratitis	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Cataract	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Vision-flashing lights/floaters	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pain nos	12.7% 229/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - chest wall	11.7% 211/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - muscle	7.7% 139/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pain - abdomen nos	6.0% 108/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Pain - headache	5.4% 97/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - joint	5.3% 95/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - bone	4.3% 78/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - limb	2.8% 51/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pain - pleura	1.4% 25/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - neck	1.2% 21/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Pain - neuralgia/peripheral nerve	1.0% 18/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Pain - liver	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Pain - eye	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pain - throat/pharynx/larynx	0.28% 5/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pain - tumor	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pain - face	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Pain - Kidney	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain - foot	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pain - dental/teeth/peridontal	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Ear and labyrinth disorders Pain - ear	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pain - rectum	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Pain - scalp	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Dyspnea	38.5% 691/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Cough	24.3% 436/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary/other	7.7% 138/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Voice changes	4.8% 87/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.0% 18/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.67% 12/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hiccoughs	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary/obstruction/stenosis of airway (bronchus)	0.33% 6/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Chest tube drainage or leak	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Trachael fistula	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Airway obstruction/upper respiratory	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure	2.2% 39/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Cystitis	0.67% 12/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urinary frequency	0.61% 11/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal/other	0.45% 8/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Obstruction/GI	0.22% 4/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Incontinence, urinary	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urine colour change	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urinary retention	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urogenital disorder	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary malignancy	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Sexual/reproductive function	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Irregular menstruation	0.11% 2/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Vaginal dryness	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Erectile dysfunction	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Intraoperative complications	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Flu-like syndrome	5.7% 102/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Syndromes/other-superior cava vein	0.83% 15/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Syndromes/other	0.17% 3/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Antiphospholipid syndrome	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Ill-defined disorder	0.06% 1/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Uncoded	0.61% 11/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Thrombosis/embolism	2.3% 42/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vascular/other	0.56% 10/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Phlebitis	0.39% 7/1797 • From the administration of first dose of study medication to the end of study or until death. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Additional Information

Medical Communications

Hoffmann- LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER