Trial Outcomes & Findings for BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (NCT NCT00117637)

Last Updated: 2014-10-31

Results Overview

Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

189 participants

Primary outcome timeframe

From randomization of the first subject until 15 months later, assessed every 8 weeks

Results posted on

2014-10-31

Participant Flow

The start of enrollment was 14 June 2005 and the last day of enrollment was 12 September 2005.

All 189 (97 Sorafenib/92 Interferon) randomized subjects were included in the intent to treat (ITT) population, and 187 (97 Sorafenib/90 Interferon) were included in the safety population according to the protocol, which defined eligibility for safety analyses by the prerequisite that a patient had received at least one dose of study medication.

Participant milestones

Participant milestones
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
First Intervention (Period 1) STARTED	97	92
First Intervention (Period 1) Subjects Received Treatment	97	90
First Intervention (Period 1) COMPLETED	79	67
First Intervention (Period 1) NOT COMPLETED	18	25
Second Intervention (Period 2) STARTED	49	61
Second Intervention (Period 2) Subjects Received Treatment	49	61
Second Intervention (Period 2) COMPLETED	39	39
Second Intervention (Period 2) NOT COMPLETED	10	22

Reasons for withdrawal

Reasons for withdrawal
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
First Intervention (Period 1) Adverse Event	11	16
First Intervention (Period 1) Lost to Follow-up	0	2
First Intervention (Period 1) Protocol Violation	1	0
First Intervention (Period 1) Withdrawal by Subject	2	4
First Intervention (Period 1) study terminated by the sponsor	3	1
First Intervention (Period 1) protocol driven decision point	1	0
First Intervention (Period 1) investig. decision, not protocol driven	0	1
First Intervention (Period 1) reason not reported	0	1
Second Intervention (Period 2) Adverse Event	0	9
Second Intervention (Period 2) Lost to Follow-up	1	0
Second Intervention (Period 2) Protocol Violation	1	0
Second Intervention (Period 2) Withdrawal by Subject	4	3
Second Intervention (Period 2) study terminated by the sponsor	2	9
Second Intervention (Period 2) non compliant with study medication	1	1
Second Intervention (Period 2) reason not reported	1	0

Baseline Characteristics

BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).	Total n=189 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62.5 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	40 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	52 Participants n=7 Participants	117 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0	56 participants n=5 Participants	49 participants n=7 Participants	105 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1	41 participants n=5 Participants	43 participants n=7 Participants	84 participants n=5 Participants
Motzer risk factors low	52 participants n=5 Participants	47 participants n=7 Participants	99 participants n=5 Participants
Motzer risk factors intermediate	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants
Motzer risk factors high	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Motzer risk factors missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race White	68 participants n=5 Participants	75 participants n=7 Participants	143 participants n=5 Participants
Race Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race Missing	29 participants n=5 Participants	16 participants n=7 Participants	45 participants n=5 Participants
Renal Cell Carcinoma (RCC) subtype clear cell	85 participants n=5 Participants	81 participants n=7 Participants	166 participants n=5 Participants
Renal Cell Carcinoma (RCC) subtype other variant	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
Time since first progression	0.2 years n=5 Participants	0.2 years n=7 Participants	0.2 years n=5 Participants
Time since initial diagnosis	0.9 years n=5 Participants	1 years n=7 Participants	1 years n=5 Participants

PRIMARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period	5.7 months Interval 5.0 to 7.4	5.6 months Interval 3.7 to 7.4

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period	5.6 months Interval 5.4 to 7.5	7.0 months Interval 5.4 to 8.8

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Disease Control (DC) According to Independent Central Review for the First Intervention Period disease control (CR or PR or SD)	77 participants	59 participants
Disease Control (DC) According to Independent Central Review for the First Intervention Period no disease control	10 participants	24 participants
Disease Control (DC) According to Independent Central Review for the First Intervention Period Unknown	10 participants	9 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Disease Control (DC) According to the Investigator Assessment for the First Intervention Period disease control (CR or PR or SD)	83 participants	62 participants
Disease Control (DC) According to the Investigator Assessment for the First Intervention Period no disease control	7 participants	24 participants
Disease Control (DC) According to the Investigator Assessment for the First Intervention Period Unknown	7 participants	6 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=49 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=61 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period disease control (CR or PR or SD)	25 participants	49 participants
Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period no disease control	16 participants	6 participants
Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period Unknown	8 participants	6 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Population: The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.

The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions:" I have been short in breath" and "I have been coughing"; its score ranges from 0 to 8.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=91 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=87 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period	6.4 scores on a scale Interval 3.3 to 9.6	5.1 scores on a scale Interval 0.8 to 9.4

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=37 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=42 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period	5.7 scores on a scale Interval -8.2 to 19.7	6.4 scores on a scale Interval -1.2 to 14.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=90 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=86 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period	40.5 scores on a scale Interval 15.9 to 65.1	34.6 scores on a scale Interval 4.4 to 64.8

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=37 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=42 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period	34.6 scores on a scale Interval 6.3 to 62.9	42.3 scores on a scale Interval 9.5 to 75.2

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=89 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=86 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period	104 scores on a scale Interval 29.0 to 179.0	93 scores on a scale Interval -9.0 to 195.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=37 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=40 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period	89.7 scores on a scale Interval 18.2 to 161.1	108.4 scores on a scale Interval 17.6 to 199.2

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=29 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=34 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period	52 scores on a scale Interval 44.0 to 61.0	42 scores on a scale Interval 34.0 to 50.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=27 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=30 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period	63 scores on a scale Interval 54.0 to 72.0	46 scores on a scale Interval 37.0 to 54.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=30 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=33 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period	82 scores on a scale Interval 75.0 to 89.0	66 scores on a scale Interval 60.0 to 73.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=30 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=33 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period	60 scores on a scale Interval 51.0 to 70.0	46 scores on a scale Interval 37.0 to 55.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=10 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=9 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period	56.9 scores on a scale Interval 40.6 to 73.1	40.3 scores on a scale Interval 22.1 to 58.5

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=10 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=8 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period	61.3 scores on a scale Interval 43.2 to 79.3	57.6 scores on a scale Interval 37.4 to 77.8

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=11 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=9 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period	86.5 scores on a scale Interval 74.7 to 98.3	82.5 scores on a scale Interval 68.9 to 96.1

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=11 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=8 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period	39.9 scores on a scale Interval 17.1 to 62.7	35.4 scores on a scale Interval 9.4 to 61.8

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Tumor Response According to the Independent Radiological Review for the First Intervention Period Complete Response (CR)	0 participants	1 participants
Tumor Response According to the Independent Radiological Review for the First Intervention Period Partial Response (PR)	5 participants	7 participants
Tumor Response According to the Independent Radiological Review for the First Intervention Period Stable Disease (SD)	72 participants	51 participants
Tumor Response According to the Independent Radiological Review for the First Intervention Period Progressive Disease (PD)	10 participants	24 participants
Tumor Response According to the Independent Radiological Review for the First Intervention Period Not Evaluated	10 participants	9 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Tumor Response According to the Investigator Assessment for the First Intervention Period Complete Response (CR)	0 participants	1 participants
Tumor Response According to the Investigator Assessment for the First Intervention Period Partial Response (PR)	21 participants	13 participants
Tumor Response According to the Investigator Assessment for the First Intervention Period Stable Disease (SD)	62 participants	48 participants
Tumor Response According to the Investigator Assessment for the First Intervention Period Progressive Disease (PD)	7 participants	24 participants
Tumor Response According to the Investigator Assessment for the First Intervention Period Not Evaluated	7 participants	6 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=49 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=61 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Tumor Response According to the Investigator Assessment for the Second Intervention Period Partial Response (PR)	0 participants	11 participants
Tumor Response According to the Investigator Assessment for the Second Intervention Period Complete Response (CR)	0 participants	1 participants
Tumor Response According to the Investigator Assessment for the Second Intervention Period Stable Disease (SD)	25 participants	37 participants
Tumor Response According to the Investigator Assessment for the Second Intervention Period Progressive Disease (PD)	16 participants	6 participants
Tumor Response According to the Investigator Assessment for the Second Intervention Period Not Evaluated	8 participants	6 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=49 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=61 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Progression Free Survival According to the Investigator Assessment (Second Intervention Period)	4.5 months Interval 2.4 to 6.5	5.5 months Interval 3.8 to 7.1

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=97 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=92 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Overall Survival (OS)	14.8 months Interval 11.3 to 17.7	26.9 months Interval 18.3 to 33.8

SECONDARY outcome

Timeframe: From start of treatment of the first subject until 15 months later assessed every 4 weeks.

Population: Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.

Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=24 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Slope - Change in Trough Concentration/Cycle	-8.3 100*(mg/L/cycle) Interval -29.6 to 12.9	—

SECONDARY outcome

Timeframe: From start of treatment of the first subject until 15 months later assessed every 4 weeks.

Population: Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg or 600 mg BID) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.

Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=24 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Average of All Trough Plasma Concentrations	93.9 100*mg/L Interval 77.1 to 114.3	—

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=5 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=8 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Duration of Response According to the Independent Radiological Review for the First Intervention Period	7.5 months Interval 7.5 to 7.5	7.7 months Interval 2.1 to 7.8

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=21 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=14 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Duration of Response According to the Investigator Assessment for the First Intervention Period	4.4 months Interval 1.2 to 22.0	9.2 months Interval 1.5 to 19.7

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=12 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Duration of Response According to the Investigator Assessment for the Second Intervention Period	—	5.5 months Interval 1.1 to 16.7

SECONDARY outcome

Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks

Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=5 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=8 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Time to Response According to the Independent Radiological Review for the First Intervention Period	1.8 months Interval 1.7 to 3.7	5.4 months Interval 3.7 to 11.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=21 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=14 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Time to Response According to the Investigator Assessment for the First Intervention Period	3.5 months Interval 1.6 to 11.1	5.4 months Interval 1.2 to 18.3

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=12 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Time to Response According to the Investigator Assessment for the Second Intervention Period	—	1.7 months Interval 1.6 to 5.4

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

Population: At the time of the analysis, only 95 subjects in Sorafenib 400 mg bid group and 89 in Interferon group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)

Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=95 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=89 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 0= Fully active without restriction	20 participants	19 participants
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 1= Restricted in physically strenuous activity	48 participants	42 participants
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 2= Ambulatory, capable of all selfcare	20 participants	21 participants
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 3= Capable of limited selfcare	5 participants	5 participants
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 4= Completely disabled	1 participants	2 participants
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period 5= Dead	1 participants	0 participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

Population: At the time of the analysis, only 45 subjects in Sorafenib 400/600 mg bid group and 58 in Interferon/Sorafenib 400 mg bid group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)

Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).

Outcome measures

Outcome measures
Measure	First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg n=45 Participants Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg n=58 Participants Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 0= Fully active without restriction	5 participant s	16 participant s
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 1= Restricted in physically strenuous activity	25 participant s	26 participant s
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 2= Ambulatory, capable of all selfcare	10 participant s	10 participant s
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 3= Capable of limited selfcare	4 participant s	5 participant s
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 4= Completely disabled	1 participant s	1 participant s
Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period 5= Dead	0 participant s	0 participant s

Adverse Events

Sorafenib 400 mg in Period 1

Serious events: 47 serious events

Other events: 93 other events

Deaths: 0 deaths

Interferon Therapy in Period 1

Serious events: 36 serious events

Other events: 84 other events

Deaths: 0 deaths

Sorafenib 600 mg (as Dose Escalation After 400 mg)

Serious events: 14 serious events

Other events: 40 other events

Deaths: 0 deaths

Sorafenib 400 mg (After Interferon Therapy)

Serious events: 30 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication will be discussed with the sponsor prior to release and written consent of the sponsor will be obtained. A draft manuscript of the publication or abstract must be sent to sponsor thirty days in advance of submission.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Sorafenib 400 mg in Period 1 n=97 participants at risk Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	Interferon Therapy in Period 1 n=90 participants at risk Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).	Sorafenib 600 mg (as Dose Escalation After 400 mg) n=49 participants at risk Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	Sorafenib 400 mg (After Interferon Therapy) n=61 participants at risk Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Immune system disorders allergic reaction	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Ear and labyrinth disorders auditory / ear - other	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders hemoglobin	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.7% 6/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.1% 2/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders platelets	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders conduction abnormality, asystole	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders supraventricular arrhythmia, supraventricular arrhythmi	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders supraventricular arrhythmia, atrial fibrillation	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders cardiopulmonary arrest	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders cardiac ischemia / infarction	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders cardiac general - other	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders death not associated with CTCAE term, death NOS	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders death not associated with CTCAE term, disease progress	10.3% 10/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.1% 2/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	11.5% 7/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders fever	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders fatigue	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	3.3% 3/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	3.3% 2/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders constitutional symptoms - other	6.2% 6/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.4% 4/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.2% 5/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders ascites	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders constipation	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders dehydration	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders diarrhea	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	3.3% 2/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders nausea	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders obstruction, GI, stomach	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders perforation, GI, colon	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders vomiting	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders ileus	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders GI - other	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hematoma	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, colon	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, stomach	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, lower GI NOS	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, upper GI NOS	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage - other	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage pulmonary, bronchopulmonary NOS	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, anus	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage, GI, varices (rectal)	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Hepatobiliary disorders hepatobiliary - other	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Hepatobiliary disorders liver dysfunction	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection (documented clinically), appendix	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with normal ANC, abdomen NOS	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with normal ANC, lung (pneumonia)	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with unknown ANC, bronchus	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)

Other adverse events
Measure	Sorafenib 400 mg in Period 1 n=97 participants at risk Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	Interferon Therapy in Period 1 n=90 participants at risk Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).	Sorafenib 600 mg (as Dose Escalation After 400 mg) n=49 participants at risk Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.	Sorafenib 400 mg (After Interferon Therapy) n=61 participants at risk Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Immune system disorders rhinitis	6.2% 6/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders neutrophils	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	14.4% 13/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders hemoglobin	14.4% 14/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	25.6% 23/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	20.4% 10/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	13.1% 8/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders platelets	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	12.2% 11/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.1% 2/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders leukocytes	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	12.2% 11/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders lymphopenia	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.2% 4/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.9% 3/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Cardiac disorders hypertension	24.7% 24/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	7.8% 7/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	21.3% 13/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders fever	10.3% 10/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	33.3% 30/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.1% 2/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders insomnia	2.1% 2/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.9% 8/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders fatigue	49.5% 48/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	45.6% 41/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	32.7% 16/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	36.1% 22/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders weight loss	26.8% 26/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	26.7% 24/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	24.5% 12/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	16.4% 10/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders constitutional symptoms - other	7.2% 7/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	12.2% 11/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
General disorders rigors / chills	1.0% 1/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	11.1% 10/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders anorexia	35.1% 34/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	31.1% 28/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	22.4% 11/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	13.1% 8/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders constipation	12.4% 12/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	14.8% 9/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders diarrhea	55.7% 54/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	15.6% 14/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	24.5% 12/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	50.8% 31/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders dry mouth	5.2% 5/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders mucositis (functional / symptomatic), oral cavity	12.4% 12/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	13.1% 8/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders mucositis (clinical exam), oral cavity	5.2% 5/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders nausea	24.7% 24/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	28.9% 26/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.2% 5/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	23.0% 14/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders taste alteration	6.2% 6/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.7% 6/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Gastrointestinal disorders vomiting	18.6% 18/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	16.7% 15/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.2% 5/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	14.8% 9/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Vascular disorders hemorrhage pulmonary, nose	5.2% 5/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.1% 1/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with normal ANC, urinary tract NOS	7.2% 7/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection - other	12.4% 12/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.2% 5/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	11.5% 7/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with unknown ANC, urinary tract NOS	5.2% 5/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection (documented clinically), urinary tract NOS	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Infections and infestations infection with normal ANC, upper airway NOS	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Blood and lymphatic system disorders edema: limb	4.1% 4/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	5.6% 5/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.2% 5/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	3.3% 2/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders ALT	5.2% 5/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.9% 8/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders AST	6.2% 6/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.0% 9/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders creatinine	3.1% 3/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.7% 6/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders hyperuricemia	8.2% 8/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.2% 2/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	10.2% 5/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.2% 5/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders lipase	16.5% 16/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	5.6% 5/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	2.0% 1/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	11.5% 7/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders amylase	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	4.9% 3/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders hypercalcemia	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders hypoalbuminemia	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.2% 4/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	3.3% 2/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders hypokalemia	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	8.2% 4/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders hyponatremia	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	1.6% 1/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)
Metabolism and nutrition disorders metabolic / lab - other	0.00% 0/97 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	0.00% 0/90 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.1% 3/49 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)	6.6% 4/61 Acronyms and abbreviations used: Common Terminology Criteria for Adverse Events (CTCAE); Not Otherwise Specified (NOS); Gastrointestinal (GI); Absolute Neutrophil Count (ANC); Alanine aminotransferase (ALT); Aspartate aminotransferase (AST); Central nervous system (CNS); Acute respiratory distress syndrome (ARDS)