Trial Outcomes & Findings for OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer (NCT NCT00076310)

Last Updated: 2026-04-15

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter

Results posted on

2026-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental (OSI-774 Erlotinib) 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Overall Study STARTED	50
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental (OSI-774 Erlotinib) 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Overall Study Adverse Event	9
Overall Study Death	7
Overall Study patient withdrawal	1

Baseline Characteristics

OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental (OSI-774 Erlotinib) n=50 Participants 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Age, Categorical <=18 years	0 Participants n=193 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=193 Participants
Age, Categorical >=65 years	7 Participants n=193 Participants
Age, Continuous	57 years n=193 Participants
Sex: Female, Male Female	8 Participants n=193 Participants
Sex: Female, Male Male	42 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	1 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	0 Participants n=193 Participants
Race (NIH/OMB) White	48 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=193 Participants
Region of Enrollment United States	50 participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Performance Status 0	7 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Performance Status 1	41 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Performance Status 2	2 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Primary Site: Oropharynx	19 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Primary Site: Oral Cavity	15 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Primary Site: Larynx	11 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Primary Site: Hypopharynx	3 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Primary Site: Unknown	2 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Disease Status at Entry: Locoregional Recurrence	31 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Disease Status at Entry: Metastatic Disease	19 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Smoking Status: Current	13 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Smoking Status: Former	25 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Smoking Status: Never	12 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Prior Treatment: Radiotherapy alone	4 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Prior Treatment: Surgery + Radiotherapy	20 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Prior Treatment: Chemotherapy + Radiotherapy	5 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Prior Treatment: Chemotherapy + Radiotherapy + Surgery	14 Participants n=193 Participants
Distribution of categorical clinical characteristics among evaluable patients Prior Treatment: Untreated	7 Participants n=193 Participants

PRIMARY outcome

Timeframe: after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter

Outcome measures

Outcome measures
Measure	Experimental (OSI-774 Erlotinib) n=50 Participants 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Overall Response Assessment (Radiographic RECIST) RECIST Response Assessment: CR	4 Participants
Overall Response Assessment (Radiographic RECIST) RECIST Response Assessment: PR	27 Participants
Overall Response Assessment (Radiographic RECIST) RECIST Response Assessment: SD	13 Participants
Overall Response Assessment (Radiographic RECIST) RECIST Response Assessment: PD	3 Participants
Overall Response Assessment (Radiographic RECIST) RECIST Response Assessment: NE	3 Participants

SECONDARY outcome

Timeframe: From treatment initiation until 150 months after initiation of treatment

Analyses of overall survival (OS) and progression-free survival (PFS) were performed. OS was defined as from treatment initiation to death or last follow-up time. PFS was defined as from treatment initiation to progression or death, whichever occurred first, or last follow-up. The distribution was estimated by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Experimental (OSI-774 Erlotinib) n=50 Participants 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Progression Free Survival and Overall Survival Duration Assessments PFS	6.11 Months Interval 5.32 to 7.59
Progression Free Survival and Overall Survival Duration Assessments OS	11 Months Interval 8.28 to 14.9

SECONDARY outcome

Timeframe: time of first drug administration to 30 days after last drug administration (maximum of 6 months)

Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

Outcome measures

Outcome measures
Measure	Experimental (OSI-774 Erlotinib) n=50 Participants 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Toxicity -- Number of Adverse Events Grade 4, Definite	0 adverse events
Toxicity -- Number of Adverse Events Grade 4, Probable	1 adverse events
Toxicity -- Number of Adverse Events Grade 4, Possible	26 adverse events
Toxicity -- Number of Adverse Events Grade 4, Unlikely	3 adverse events
Toxicity -- Number of Adverse Events Grade 3, Unlikely	1 adverse events
Toxicity -- Number of Adverse Events Grade 3, Unrelated	2 adverse events
Toxicity -- Number of Adverse Events Grade 2, Probable	1 adverse events
Toxicity -- Number of Adverse Events Grade 2, Possible	62 adverse events
Toxicity -- Number of Adverse Events Grade 2, Unrelated	26 adverse events
Toxicity -- Number of Adverse Events Grade 4, Unrelated	2 adverse events
Toxicity -- Number of Adverse Events Grade 3, Definite	0 adverse events
Toxicity -- Number of Adverse Events Grade 3, Probable	4 adverse events
Toxicity -- Number of Adverse Events Grade 3, Possible	50 adverse events
Toxicity -- Number of Adverse Events Grade 2, Definite	0 adverse events
Toxicity -- Number of Adverse Events Grade 2, Unlikely	1 adverse events
Toxicity -- Number of Adverse Events Grade 1, Definite	0 adverse events
Toxicity -- Number of Adverse Events Grade 1, Probable	0 adverse events
Toxicity -- Number of Adverse Events Grade 1, Possible	372 adverse events
Toxicity -- Number of Adverse Events Grade 1, Unlikely	7 adverse events
Toxicity -- Number of Adverse Events Grade 1, Unrelated	467 adverse events

Adverse Events

Experimental (OSI-774 Erlotinib)

Serious events: 29 serious events

Other events: 50 other events

Deaths: 48 deaths

Serious adverse events

Serious adverse events
Measure	Experimental (OSI-774 Erlotinib) n=50 participants at risk 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Gastrointestinal disorders Abdominal abscess	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Abdominal pain	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Acute metabolic acidosis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Altered mental state	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Anemia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Anorexia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia/pneumonitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Atrial flutter/atrial fibrillation	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Bacteremia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Bleeding	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Bradycardia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Death	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Dehydration	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Diarrhea	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Embolic stroke	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Fatigue	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Febrile neutropenia	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Fever	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders GI bleed	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders GI hemorrhage	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Granulocytopenia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Headaches	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Hemoglobin	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hemoptysis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Hypertension	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypocalcemia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypokalemia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hyponatremia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Hypotension	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Ileus	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Infection	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Inferior wall myocardial infarction w/ stent placement	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Renal and urinary disorders Inguinal Herniography	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Intraabdominal abscess	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Meningitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations MRSA infection	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Nausea	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Neutropenia	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Osteomyelitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Pain	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Renal and urinary disorders Renal insufficiency	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Sepsis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Sinus ventricular tachycardia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Stridor	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Syncope	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Vomiting	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Weakness	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.

Other adverse events

Other adverse events
Measure	Experimental (OSI-774 Erlotinib) n=50 participants at risk 6 21-day cycles of IV cisplatin (75 mg/m2)/docetaxel (60-75 mg/m2) and once daily oral 100-150 mg erlotinib
Skin and subcutaneous tissue disorders Acne	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Albumin	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Alkaline phosphatase	24.0% 12/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Allergic reaction	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Alopecia	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations ALT, SGPT	12.0% 6/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Amylase	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Anemia	52.0% 26/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Anorexia	32.0% 16/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Anxiety	16.0% 8/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations AST, SGOT	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Bicarbonate	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Bilirubin (hyperbilirubinemia)	28.0% 14/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Bloody stool	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations BUN	32.0% 16/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Cardiac ischemia/infarction	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Chloride	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Cold intolerance	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Colitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Constipation	36.0% 18/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Cough	24.0% 12/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Creatinine	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Dehydration	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Depression	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Dermal change	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Diarrhea	60.0% 30/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Dizziness	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Dry mouth	32.0% 16/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Dry skin	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Dysphagia	58.0% 29/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 10/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Earache	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Edema	34.0% 17/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Ejaculatory dysfunction	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Eye irritation	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Eyelid dysfunction	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Fatigue	82.0% 41/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Fever	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Fistula, infection	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Gastrointestinal	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Hallucination	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Headache	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Hearing	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Heartburn	12.0% 6/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Hematocrit	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Hemoglobin	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hemoptysis	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage/bleeding (nose)	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Hemorrhage/bleeding (oral)	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Hemorrhoids	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hiccoughs	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypercalcemia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hyperglycemia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hyperkalemia	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Hypertension	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Hyperthyroidism	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hyperuricemia	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypoalbuminemia	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypocalcemia	20.0% 10/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Hypocapnia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypokalemia	12.0% 6/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypomagnesemia	28.0% 14/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hyponatremia	34.0% 17/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Metabolism and nutrition disorders Hypophosphatemia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Hypotension	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Indigestion	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Infection	12.0% 6/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Insomnia	38.0% 19/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Intra-op injury (oral cavity)	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Keratitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations LDH	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Leukocytes	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Leukopenia	32.0% 16/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Lumbar spine ROM	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Vascular disorders Lymphedema	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Lymphopenia	70.0% 35/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Mental status	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Mucositis	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Muscle cramps	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Nail changes	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Nasal/paranasal reactions	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Nausea	66.0% 33/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Necrosis, GI (oral)	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Neuropathy: motor	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Neuropathy: sensory	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Neutrophils (ANC/AGC)	28.0% 14/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Ocular/vision	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Oral thrush	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Pain	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (back)	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pain (chest/thorax)	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Pain (ear)	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Pain (face)	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (jaw)	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (joint)	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (limb)	10.0% 5/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (muscle)	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (neck)	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Pain (oral cavity)	32.0% 16/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Pain (oropharyngeal)	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Pain (rib)	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Pain (stomach)	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pain (throat/pharynx/larynx)	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Palpitations	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Pericardial effusion	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Phosphorous	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Platelets	12.0% 6/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Renal and urinary disorders Proteinuria	14.0% 7/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Pruritus	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	62.0% 31/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders RBC	24.0% 12/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Redness of eyes	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Renal and urinary disorders Renal insufficiency	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Respiratory symptoms	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Rigors, chills	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Salivary gland changes	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Sensory	26.0% 13/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Skin infection	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	18.0% 9/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Stomach infection	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Stomatitis	20.0% 10/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Sweating	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Cardiac disorders Tachycardia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Nervous system disorders Taste alteration (dysgeusia)	8.0% 4/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Skin and subcutaneous tissue disorders Telangiectasia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Blood and lymphatic system disorders Thrombocytopenia	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Thyroid function, low	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Tinnitus	16.0% 8/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Musculoskeletal and connective tissue disorders Trismus	40.0% 20/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations TSH	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Ulceration	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Infections and infestations Urinary tract infection	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Vertigo	2.0% 1/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Respiratory, thoracic and mediastinal disorders Voice changes	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Vomiting	22.0% 11/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
General disorders Watery eye	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Weight gain	4.0% 2/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Investigations Weight loss	24.0% 12/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.
Gastrointestinal disorders Xerostomia	6.0% 3/50 • Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment.

Additional Information

Xiuning Le, MD

MD Anderson Cancer Center

Phone: (713) 792-6980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place