Trial Outcomes & Findings for A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00449033)

NCT ID: NCT00449033

Last Updated: 2015-04-23

Results Overview

Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 904 participants
• Primary outcome timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first
• Results posted on: 2015-04-23

Participant Flow

This study was conducted at 93 centers across 16 countries, which enrolled and randomized at least one patient. From a total of 1011 patients who were screened, 904 patients were randomized between 23 FEB 2007 and 03 MAR 2009.

All 904 randomized patients were included in the intent to treat (ITT) population. A total of 901 patients received at least one dose of study medication and were included in the safety population. Study medication included administration of any one of the following treatments: gemcitabine, cisplatin, sorafenib or placebo.

Participant milestones

Measure	Sorafenib (Nexavar, BAY43-9006) + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Treatment Period STARTED	452	452
Treatment Period Received Treatment	452	449
Treatment Period COMPLETED	0	0
Treatment Period NOT COMPLETED	452	452
Follow-up Period STARTED	425	434
Follow-up Period COMPLETED	0	0
Follow-up Period NOT COMPLETED	425	434

Reasons for withdrawal

Measure	Sorafenib (Nexavar, BAY43-9006) + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Treatment Period Adverse Event	117	83
Treatment Period Death	21	12
Treatment Period Lost to Follow-up	0	2
Treatment Period Physician Decision	4	5
Treatment Period Protocol Violation	8	7
Treatment Period Disease Progression	231	288
Treatment Period Consent Withdrawn	36	20
Treatment Period Amended Protocol Criteria	22	18
Treatment Period Non-compliance	7	8
Treatment Period Second Malignancy	0	1
Treatment Period Reason Missing	0	4
Treatment Period Treatment Ongoing	6	4
Follow-up Period Death	299	311
Follow-up Period Lost to Follow-up	6	10
Follow-up Period Reason Missing	120	113

Baseline Characteristics

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=452 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=452 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.	Total n=904 Participants Total of all reporting groups
Age, Continuous	60 Years n=5 Participants	59 Years n=7 Participants	59 Years n=5 Participants
Sex: Female, Male Female	168 Participants n=5 Participants	155 Participants n=7 Participants	323 Participants n=5 Participants
Sex: Female, Male Male	284 Participants n=5 Participants	297 Participants n=7 Participants	581 Participants n=5 Participants
histology of the tumor Non-squamous	385 Participants n=5 Participants	387 Participants n=7 Participants	772 Participants n=5 Participants
histology of the tumor Squamous	67 Participants n=5 Participants	65 Participants n=7 Participants	132 Participants n=5 Participants
Time since initial diagnosis	2.6 Weeks n=5 Participants	2.9 Weeks n=7 Participants	2.7 Weeks n=5 Participants
Smoking history Non-smoker	111 Participants n=5 Participants	107 Participants n=7 Participants	218 Participants n=5 Participants
Smoking history Passive smoker	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Smoking history Past or present smoker	338 Participants n=5 Participants	342 Participants n=7 Participants	680 Participants n=5 Participants
Smoking history Not available	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Tumor stage at randomization Stage III B	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Tumor stage at randomization Stage IV	395 Participants n=5 Participants	397 Participants n=7 Participants	792 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) Performance Status at randomization 0	176 Participants n=5 Participants	175 Participants n=7 Participants	351 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) Performance Status at randomization 1	276 Participants n=5 Participants	277 Participants n=7 Participants	553 Participants n=5 Participants

PRIMARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Population: Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.

Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=385 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=387 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Overall Survival (OS) in the ITT (Non-squamous) Population	376 days Interval 333.0 to 416.0	379 days Interval 335.0 to 414.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Population: Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.

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

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=452 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=452 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
OS in the ITT (Both Squamous and Non-squamous) Population	371 days Interval 322.0 to 410.0	378 days Interval 335.0 to 412.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Population: Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.

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

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=67 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=65 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
OS in the ITT (Squamous) Population	254 days Interval 197.0 to 455.0	374 days Interval 282.0 to 519.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.

PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=385 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=387 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Progression-free Survival (PFS) in the ITT (Non-squamous) Population	183 days Interval 168.0 to 208.0	168 days Interval 156.0 to 174.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.

TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=385 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=387 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Time to Progression (TTP) in the ITT (Non-squamous) Population	185 days Interval 171.0 to 210.0	167 days Interval 156.0 to 173.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of Tumour Response based on ITT (non-squamous) population.

Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=385 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=387 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population CR	0.0 percentage of participants Interval 0.0 to 0.8	0.0 percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population confirmed PR	27.8 percentage of participants Interval 23.4 to 32.6	25.8 percentage of participants Interval 21.6 to 30.5
Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population SD	34.3 percentage of participants Interval 29.6 to 39.3	37.2 percentage of participants Interval 32.4 to 42.2
Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population PD	10.9 percentage of participants Interval 8.0 to 14.5	17.1 percentage of participants Interval 13.4 to 21.2
Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population Not assessable	27.0 percentage of participants Interval 22.6 to 31.7	19.9 percentage of participants Interval 16.0 to 24.2

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of Disease Control based on ITT (non-squamous) population.

DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=385 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=387 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Disease Control (DC) in the ITT (Non-squamous) Population	62.1 percentage of participants	63.1 percentage of participants

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.

Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=107 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=100 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Duration of Response in the ITT (Non-squamous) Population	171 days Interval 147.0 to 203.0	133 days Interval 126.0 to 146.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Population: Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.

Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=174 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=210 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Duration of Stable Disease (SD) in the ITT (Non-squamous) Population	144 days Interval 126.0 to 168.0	131 days Interval 125.0 to 156.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Population: Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.

TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=107 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=100 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Time to Response (TTR) in the ITT (Non-squamous) Population	42 days Interval 41.0 to 44.0	43 days Interval 42.0 to 44.0

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months

Population: All patients valid for the ITT analysis who have a baseline and at least one post baseline value.

The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=282 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=283 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population cycle 2 (day 22)	90.6 scores on a scale Interval 88.5 to 92.6	94.0 scores on a scale Interval 92.2 to 95.9
Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population cycle 4 (day 64)	90.1 scores on a scale Interval 88.1 to 92.2	93.6 scores on a scale Interval 91.7 to 95.4
Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population cycle 6 (day 106)	89.7 scores on a scale Interval 87.5 to 91.8	93.1 scores on a scale Interval 91.1 to 95.1

SECONDARY outcome

Timeframe: from randomization of the first patient to 38 months later or death whatever occurs first.

Population: All patients valid for the ITT analysis who have a baseline and at least one post baseline value.

LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=314 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=317 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 1 (day 1)	20.0 scores on a scale Interval 19.6 to 20.4	20.5 scores on a scale Interval 20.1 to 20.9
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 2 (day 22)	19.9 scores on a scale Interval 19.5 to 20.4	20.5 scores on a scale Interval 20.1 to 20.8
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 3 (day 43)	19.9 scores on a scale Interval 19.4 to 20.3	20.4 scores on a scale Interval 20.0 to 20.8
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 4 (day 64)	19.8 scores on a scale Interval 19.4 to 20.2	20.3 scores on a scale Interval 19.9 to 20.7
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 5 (day 85)	19.7 scores on a scale Interval 19.3 to 20.2	20.3 scores on a scale Interval 19.8 to 20.7
Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population cycle 6 (day 106)	19.7 scores on a scale Interval 19.2 to 20.1	20.2 scores on a scale Interval 19.7 to 20.6

SECONDARY outcome

Timeframe: from randomization of the first patient to 38 months later or death whatever occurs first

Population: All patients valid for the ITT analysis who have a baseline and at least one post baseline value.

TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=321 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=333 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population	6.9 months Interval 5.8 to 8.7	4.5 months Interval 3.6 to 5.9

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months later or death whatever occurs first

Population: All patients valid for the ITT analysis who have a baseline and at least one post baseline value.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=323 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=318 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 1 (day 1)	0.70 scores on a scale Interval 0.67 to 0.72	0.76 scores on a scale Interval 0.73 to 0.78
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 2 (day 22)	0.69 scores on a scale Interval 0.67 to 0.72	0.75 scores on a scale Interval 0.73 to 0.78
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 3 (day 43)	0.69 scores on a scale Interval 0.66 to 0.71	0.75 scores on a scale Interval 0.72 to 0.77
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 4 (day 64)	0.68 scores on a scale Interval 0.66 to 0.71	0.74 scores on a scale Interval 0.72 to 0.76
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 5 (day 85)	0.68 scores on a scale Interval 0.65 to 0.7	0.73 scores on a scale Interval 0.71 to 0.76
Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population cycle 6 (day 106)	0.67 scores on a scale Interval 0.64 to 0.7	0.73 scores on a scale Interval 0.7 to 0.75

SECONDARY outcome

Timeframe: from randomization of the first patient until 38 months later or death whatever occurs first

Population: All patients valid for the ITT analysis who have a baseline and at least one post baseline value.

The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=315 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=313 Participants Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 1 (day 1)	66.43 scores on a scale Interval 64.65 to 68.21	68.96 scores on a scale Interval 67.18 to 70.73
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 2 (day 22)	66.43 scores on a scale Interval 64.68 to 68.18	68.96 scores on a scale Interval 67.19 to 70.72
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 3 (day 43)	66.43 scores on a scale Interval 64.68 to 68.18	68.95 scores on a scale Interval 67.18 to 70.72
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 4 (day 64)	66.43 scores on a scale Interval 64.65 to 68.2	68.95 scores on a scale Interval 67.15 to 70.75
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 5 (day 85)	66.42 scores on a scale Interval 64.61 to 68.24	68.95 scores on a scale Interval 67.1 to 70.8
EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population cycle 6 (day 106)	66.42 scores on a scale Interval 64.55 to 68.3	68.95 scores on a scale Interval 67.02 to 70.87

Adverse Events

Sorafenib (Nexavar, BAY43-9006) + GC

Serious events: 270 serious events

Other events: 440 other events

Deaths: 0 deaths

Placebo + GC

Serious events: 198 serious events

Other events: 435 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=452 participants at risk Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=449 participants at risk Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Blood and lymphatic system disorders Blood - Other	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Bone marrow cellularity	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Edema: Head and Neck	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Edema: Limb	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Hemoglobin	4.0% 18/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.7% 12/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders INR	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Leukocytes	2.7% 12/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.1% 5/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Neutrophils	4.2% 19/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.7% 12/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Platelets	13.9% 63/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	6.0% 27/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Cardiac arrhythmia - Other	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Cardiac general - Other	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Cardiac ischemia/infarction	2.0% 9/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.0% 9/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Cardiopulmonary arrest	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Conduction abnormality, Conduction abnormality NOS	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Hypertension	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Hypotension	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Left ventricular systolic dysfunction	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Pericardial effusion	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.1% 5/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Pericarditis	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Supraventricular arrhythmia, Atrial fibrillation	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Supraventricular arrhythmia, Atrial flutter	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Supraventricular arrhythmia, Supraventricular tachycardia	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Ventricular arrhythmia, Ventricular arrhythmia NOS	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Ventricular arrhythmia, Ventricular tachycardia	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Endocrine disorders Diabetes	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Endocrine disorders Endocrine - Other	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Eye disorders Optic disc edema	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Eye disorders Vitreous hemorrhage	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Anorexia	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Ascites	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Constipation	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Dehydration	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Diarrhea	1.5% 7/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Dysphagia	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Enteritis	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Esophagitis	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders GI - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Gastritis	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Ileus	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Mucositis (functional/symptomatic), Esophagus	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Mucositis (functional/symptomatic), Oral cavity	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Nausea	3.1% 14/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.3% 6/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Obstruction, GI, Colon	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Obstruction, GI, Gallbladder	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Obstruction, GI, Ileum	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Perforation, GI, Colon	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Perforation, GI, Stomach	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Stricture, GI, Colon	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Stricture, GI, Esophagus	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Vomiting	2.2% 10/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.4% 11/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Constitutional symptoms - Other	2.4% 11/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Death not associated with CTCAE term, Death NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Death not associated with CTCAE term, Disease progression NOS	4.6% 21/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	3.3% 15/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Death not associated with CTCAE term, Multi-Organ Failure	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.1% 5/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Death not associated with CTCAE term, Sudden death	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Fatigue	2.4% 11/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Fever	3.1% 14/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.3% 6/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Hypothermia	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders No code in CTCAE	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Abdomen NOS	1.8% 8/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Back	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Bone	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Chest wall	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Chest/Thorax NOS	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Extremity - limb	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Gallbladder	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Head/Headache	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Neuralgia/Peripheral nerve	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Pelvis	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Stomach	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Tumor pain	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Tumor lysis syndrome	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Weight loss	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Hepatobiliary disorders Hepatobiliary - Other	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Hepatobiliary disorders Liver dysfunction	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Hepatobiliary disorders Pancreatitis	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Immune system disorders Allergic reaction	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Febrile neutropenia	2.2% 10/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.3% 6/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Bladder (urinary)	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Blood	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Bronchus	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Kidney	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Lung (Pneumonia)	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Pleura (Empyema)	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection (Documented clinically), Upper airway NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Abdomen NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Anal/perianal	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Blood	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Bronchus	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Catheter-related	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Lung (Pneumonia)	4.9% 22/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.4% 11/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Meninges (Meningitis)	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Scrotum	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Skin (cellulitis)	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Soft tissue NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Urinary tract NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with unknown ANC, Blood	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with unknown ANC, Lung (Pneumonia)	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with unknown ANC, Pleura (Empyema)	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with unknown ANC, Soft tissue NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with unknown ANC, Wound	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Injury, poisoning and procedural complications Intraop injury, Jejunum	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Injury, poisoning and procedural complications Intraop injury, Lung	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders ALT	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Bilirubin (Hyperbilirubinemia)	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Creatinine	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders GFR	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hyperglycemia	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypocalcemia	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypokalemia	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypomagnesemia	1.1% 5/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hyponatremia	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypophosphatemia	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Fracture	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Muscle weakness, Extremity - lower	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Muscle weakness, Whole body/generalized	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Musculoskeletal - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Osteoporosis	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Musculoskeletal and connective tissue disorders Soft tissue necrosis, Extremity - lower	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders CNS ischemia	1.3% 6/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Confusion	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Mood alteration, Depression	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Neurology - Other	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Neuropathy: Cranial, CN II Vision	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Neuropathy: motor	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Neuropathy: sensory	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Personality	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Pyramidal tract dysfunction	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Seizure	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Somnolence	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Speech impairment	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Syncope (Fainting)	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Tremor	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Renal and urinary disorders Renal - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Renal and urinary disorders Renal failure	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders ARDS	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Airway obstruction, Bronchus	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Aspiration	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Cough	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	5.1% 23/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	5.8% 26/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.6% 7/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Pulmonary - Other	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Dermatology - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Erythema multiforme	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Hand-foot skin reaction	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Rash/desquamation	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Artery injury, Aorta	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders CNS hemorrhage	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage - Other	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage pulmonary, Bronchopulmonary NOS	1.1% 5/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage pulmonary, Lung	1.1% 5/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage pulmonary, Nose	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage pulmonary, Respiratory tract NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Abdomen NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Anus	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Colon	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Duodenum	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Rectum	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.00% 0/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Stomach	0.44% 2/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage, GI, Upper GI NOS	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Peripheral arterial ischemia	0.88% 4/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.89% 4/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Phlebitis	0.00% 0/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.67% 3/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Thrombosis/Embolism (vascular access)	0.66% 3/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.1% 5/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Thrombosis/Thrombus/Embolism	5.8% 26/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	4.9% 22/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Vascular - Other	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.45% 2/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Visceral arterial ischemia	0.22% 1/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	0.22% 1/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)

Other adverse events

Measure	Sorafenib (Nexavar, BAY43-9006) + GC n=452 participants at risk Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.	Placebo + GC n=449 participants at risk Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Blood and lymphatic system disorders Blood - Other	3.5% 16/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.6% 34/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Edema: Limb	4.9% 22/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	8.7% 39/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Hemoglobin	47.3% 214/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	49.2% 221/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Leukocytes	35.0% 158/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	32.5% 146/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Lymphopenia	6.6% 30/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	3.8% 17/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Neutrophils	46.5% 210/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	50.1% 225/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Blood and lymphatic system disorders Platelets	56.4% 255/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	46.8% 210/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Cardiac disorders Hypertension	16.8% 76/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.6% 34/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Ear and labyrinth disorders Tinnitus	5.3% 24/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.6% 34/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Anorexia	39.2% 177/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	35.2% 158/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Constipation	32.7% 148/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	29.6% 133/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Diarrhea	41.8% 189/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	17.8% 80/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Dysphagia	5.8% 26/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.8% 8/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Heartburn	8.2% 37/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.1% 32/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Mucositis (functional/symptomatic), Oral cavity	25.2% 114/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	11.1% 50/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Nausea	58.2% 263/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	55.0% 247/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Taste Alteration	6.0% 27/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.1% 32/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Gastrointestinal disorders Vomiting	44.0% 199/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	44.1% 198/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Fatigue	53.5% 242/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	52.8% 237/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Fever	14.8% 67/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	13.1% 59/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Insomnia	11.3% 51/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	12.2% 55/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Abdomen NOS	13.5% 61/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	9.4% 42/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Back	10.2% 46/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	8.2% 37/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Chest/Thorax NOS	11.9% 54/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	14.3% 64/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Extremity - limb	7.1% 32/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.8% 35/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Head/Headache	11.9% 54/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	9.6% 43/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Joint	5.3% 24/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	5.6% 25/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Muscle	5.3% 24/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	4.0% 18/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Stomach	6.0% 27/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	6.2% 28/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Pain, Throat/Pharynx/Larynx	5.1% 23/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.2% 10/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
General disorders Weight loss	12.2% 55/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	6.9% 31/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Infections and infestations Infection with normal ANC, Upper airway NOS	5.8% 26/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	6.0% 27/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders ALT	6.0% 27/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	5.3% 24/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders AST	5.5% 25/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.7% 12/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Creatinine	6.0% 27/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	8.7% 39/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypocalcemia	10.8% 49/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	4.5% 20/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypokalemia	16.6% 75/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	9.6% 43/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypomagnesemia	14.8% 67/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	12.2% 55/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hyponatremia	10.8% 49/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	9.8% 44/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Hypophosphatemia	6.9% 31/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	2.7% 12/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Metabolism and nutrition disorders Metabolic/Lab - Other	8.2% 37/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	9.8% 44/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Dizziness	12.2% 55/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	10.2% 46/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Nervous system disorders Neuropathy: sensory	15.7% 71/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	17.1% 77/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Cough	17.7% 80/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	23.6% 106/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	20.4% 92/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	19.2% 86/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Respiratory, thoracic and mediastinal disorders Voice changes	7.5% 34/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	5.1% 23/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Alopecia	32.7% 148/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	16.5% 74/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Dermatology - Other	5.5% 25/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	1.3% 6/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Dry skin	7.1% 32/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	3.3% 15/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Hand-foot skin reaction	26.8% 121/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	3.1% 14/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Pruritus	8.0% 36/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	4.2% 19/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Skin and subcutaneous tissue disorders Rash/desquamation	36.5% 165/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	20.7% 93/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Vascular disorders Hemorrhage pulmonary, Nose	17.3% 78/452 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)	7.3% 33/449 Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)

Additional Information

Therapeutic Area Head

Bayer HealthCare AG

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator, whilst free to use data from the study for scientific purposes, must not publish any document relating to the Trial without first notifying Bayer in writing and obtaining written consent. Bayer recognizes the right of the investigator to publish the results upon completion of the study. The investigator must send a draft manuscript of the publication or abstract to Bayer 60 days ahead of submission to obtain approval prior to submission of the final version for publication.
• Publication restrictions are in place

Restriction type: OTHER