Trial Outcomes & Findings for A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC). (NCT NCT00863746)

NCT ID: NCT00863746

Last Updated: 2015-01-19

Results Overview

Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 703 participants
• Primary outcome timeframe: From randomization of the first subject until 36 months later
• Results posted on: 2015-01-19

Participant Flow

Participant milestones

Measure	Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo Participants received 2 tablets of placebo orally twice daily (BID)
Treatment STARTED	350	353
Treatment Participants Received Treatment	346	351
Treatment COMPLETED	279	318
Treatment NOT COMPLETED	71	35
Survival Follow up STARTED	298	331
Survival Follow up COMPLETED	45	51
Survival Follow up NOT COMPLETED	253	280

Reasons for withdrawal

Measure	Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo Participants received 2 tablets of placebo orally twice daily (BID)
Treatment Not treated	4	2
Treatment Adverse Event	41	16
Treatment non-compliant with study medication	4	0
Treatment Consent withdrawn	15	14
Treatment Lost to Follow-up	1	0
Treatment Protocol Violation	5	3
Treatment Other	1	0
Survival Follow up Death	244	271
Survival Follow up Lost to Follow-up	2	1
Survival Follow up Consent Withdrawn	7	8

Baseline Characteristics

A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).

Baseline characteristics by cohort

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)	Total n=703 Participants Total of all reporting groups
Age, Continuous	58.9 Years STANDARD_DEVIATION 10.7 • n=5 Participants	60.9 Years STANDARD_DEVIATION 9.8 • n=7 Participants	59.9 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Age, Customized < 65 years	239 Participants n=5 Participants	222 Participants n=7 Participants	461 Participants n=5 Participants
Age, Customized >= 65 and < 75 years	91 Participants n=5 Participants	102 Participants n=7 Participants	193 Participants n=5 Participants
Age, Customized >= 75 years	20 Participants n=5 Participants	29 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	144 Participants n=7 Participants	308 Participants n=5 Participants
Sex: Female, Male Male	186 Participants n=5 Participants	209 Participants n=7 Participants	395 Participants n=5 Participants
Region (CRF [case report form]) Group 1 (North America, Northern/Western Europe)	122 Participants n=5 Participants	119 Participants n=7 Participants	241 Participants n=5 Participants
Region (CRF [case report form]) Group 2 (S. America, Eastern Europe, Asia-Pacific)	228 Participants n=5 Participants	234 Participants n=7 Participants	462 Participants n=5 Participants
Number of participants with prior anti-cancer therapy and diagnostic procedures 2 regimens	188 Participants n=5 Participants	197 Participants n=7 Participants	385 Participants n=5 Participants
Number of participants with prior anti-cancer therapy and diagnostic procedures 3 regimens	158 Participants n=5 Participants	153 Participants n=7 Participants	311 Participants n=5 Participants
Number of participants with prior anti-cancer therapy and diagnostic procedures 4 regimens	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Number of participants with prior anti-cancer therapy and diagnostic procedures 5 regimens	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Brain metastasis No	293 Participants n=5 Participants	299 Participants n=7 Participants	592 Participants n=5 Participants
Brain metastasis Yes	56 Participants n=5 Participants	54 Participants n=7 Participants	110 Participants n=5 Participants
Brain metastasis Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Prior EGFR (Epidermal Growth Factor Receptor) inhibitor treatment No	141 Participants n=5 Participants	146 Participants n=7 Participants	287 Participants n=5 Participants
Prior EGFR (Epidermal Growth Factor Receptor) inhibitor treatment Yes	209 Participants n=5 Participants	207 Participants n=7 Participants	416 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status Missing	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 0	110 Participants n=5 Participants	110 Participants n=7 Participants	220 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 1	233 Participants n=5 Participants	242 Participants n=7 Participants	475 Participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 2	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization of the first subject until 36 months later

Population: Full Analysis Set (FAS)

Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Overall Survival	248 Days Interval 224.0 to 290.0	253 Days Interval 231.0 to 301.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 36 months later assessed every 6 weeks

Population: Full Analysis Set (FAS)

Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Progression-free Survival	84 Days Interval 81.0 to 86.0	43 Days Interval 42.0 to 44.0

SECONDARY outcome

Timeframe: From randomization of the first subject until 36 months later assessed every 6 weeks

Population: Full Analysis Set (FAS)

Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Disease Control	0.4714 Proportion of participants	0.2465 Proportion of participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 36 months later assessed every 6 weeks

Population: Full Analysis Set (FAS)

Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Objective Tumor Response	0.0486 Proportion of participants	0.0085 Proportion of participants

SECONDARY outcome

Timeframe: From randomization of the first subject until 36 months later assessed every 6 weeks

Population: Full Analysis Set (FAS)

Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=350 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=353 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Time to Progression	89 Days Interval 84.0 to 124.0	43 Days Interval 42.0 to 44.0

SECONDARY outcome

Timeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Population: Patient report outcomes (PRO) analysis set

The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=318 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=332 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status Cycle 2 (n=295, 309)	-6.158 Scores on a scale Standard Deviation 22.435	-3.398 Scores on a scale Standard Deviation 18.370
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status Cycle 3 (n=233, 188)	-5.222 Scores on a scale Standard Deviation 19.881	-2.305 Scores on a scale Standard Deviation 18.976
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status Cycle 4 (n= 187, 119)	-2.763 Scores on a scale Standard Deviation 19.700	-3.782 Scores on a scale Standard Deviation 16.728
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status Cycle 5 (n= 158, 92)	-3.586 Scores on a scale Standard Deviation 18.843	-3.080 Scores on a scale Standard Deviation 18.806
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status Cycle 6 (n=136, 60)	-5.270 Scores on a scale Standard Deviation 19.845	-3.056 Scores on a scale Standard Deviation 16.089
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status End of treatment (up to Cycle 41, n=192, 221)	-12.153 Scores on a scale Standard Deviation 24.535	-12.142 Scores on a scale Standard Deviation 21.780

SECONDARY outcome

Timeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Population: Patient report outcomes (PRO) analysis set

A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=318 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=332 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale Cycle 2 (n=297, 314	0.786 Scores on a scale Standard Deviation 25.910	2.866 Scores on a scale Standard Deviation 24.325
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale Cycle 3 (n=234, 192)	-1.567 Scores on a scale Standard Deviation 24.753	-0.174 Scores on a scale Standard Deviation 23.754
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale Cycle 4 (n=187, 121)	-2.674 Scores on a scale Standard Deviation 26.751	0.000 Scores on a scale Standard Deviation 26.527
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale Cycle 5 (n=154, 92)	-0.216 Scores on a scale Standard Deviation 25.422	-1.812 Scores on a scale Standard Deviation 24.392
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale Cycle 6 (n=134, 61)	-2.239 Scores on a scale Standard Deviation 23.904	-3.825 Scores on a scale Standard Deviation 29.875
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale End of treatment (up to Cycle 41) (n=194, 225)	8.763 Scores on a scale Standard Deviation 27.103	5.333 Scores on a scale Standard Deviation 29.734

SECONDARY outcome

Timeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Population: Patient report outcomes (PRO) analysis set

A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=318 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=332 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea Cycle 2 (n=290, 309)	3.678 Scores on a scale Standard Deviation 16.251	3.740 Scores on a scale Standard Deviation 17.806
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea Cycle 3 (n=232, 189)	0.958 Scores on a scale Standard Deviation 16.021	2.058 Scores on a scale Standard Deviation 17.984
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea Cycle 4 (n=186, 120)	3.226 Scores on a scale Standard Deviation 17.258	2.963 Scores on a scale Standard Deviation 16.343
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea Cycle 5 (n=153, 91)	3.486 Scores on a scale Standard Deviation 17.169	3.419 Scores on a scale Standard Deviation 17.739
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea Cycle 6 (n=133, 61)	2.840 Scores on a scale Standard Deviation 16.843	2.004 Scores on a scale Standard Deviation 14.700
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea End of treatment (up to Cycle 31, n=191, 222)	12.158 Scores on a scale Standard Deviation 21.694	10.611 Scores on a scale Standard Deviation 22.738

SECONDARY outcome

Timeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Population: Patient report outcomes (PRO) analysis set

The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=318 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=332 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score Cycle 3 (n=228, 186)	-0.0627 Scores on a scale Standard Deviation 0.2402	-0.0386 Scores on a scale Standard Deviation 0.1998
Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score Cycle 5 (n=150, 91)	-0.0439 Scores on a scale Standard Deviation 0.2022	-0.0728 Scores on a scale Standard Deviation 0.2373
Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score End of treatment (up to cycle 41) (n=188, 219)	-0.1845 Scores on a scale Standard Deviation 0.3348	-0.1442 Scores on a scale Standard Deviation 0.3108

SECONDARY outcome

Timeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Population: Patient report outcomes (PRO) analysis set

A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)

Outcome measures

Measure	Sorafenib (Nexavar, BAY43-9006) n=318 Participants Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)	Placebo n=332 Participants Participants received 2 tablets of placebo orally twice daily (BID)
Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score Cycle 3 (n=218 , 183)	-3.73 Scores on a scale Standard Deviation 16.53	-3.48 Scores on a scale Standard Deviation 17.35
Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score Cycle 5 (n=144, 89)	-5.39 Scores on a scale Standard Deviation 16.66	-2.48 Scores on a scale Standard Deviation 16.37
Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score End of treatment (up to Cycle 41, n=184, 216)	-12.72 Scores on a scale Standard Deviation 16.65	-10.75 Scores on a scale Standard Deviation 18.90

Adverse Events

Sorafenib (Nexavar, BAY43-9006)

Serious events: 136 serious events

Other events: 332 other events

Deaths: 0 deaths

Placebo

Serious events: 111 serious events

Other events: 289 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sorafenib (Nexavar, BAY43-9006) n=346 participants at risk Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)	Placebo n=351 participants at risk Participants received 2 tablets of placebo orally twice daily (BID)
Blood and lymphatic system disorders DIC	0.29% 1/346	0.00% 0/351
Blood and lymphatic system disorders Edema: Limb	0.00% 0/346	0.28% 1/351
Blood and lymphatic system disorders Hemoglobin	0.00% 0/346	0.28% 1/351
Blood and lymphatic system disorders INR	0.00% 0/346	0.28% 1/351
Blood and lymphatic system disorders Leukocytes	0.00% 0/346	0.28% 1/351
Blood and lymphatic system disorders Neutrophils	0.29% 1/346	0.00% 0/351
Blood and lymphatic system disorders Platelets	0.58% 2/346	0.28% 1/351
Cardiac disorders Cardiac general - Other	0.58% 2/346	0.28% 1/351
Cardiac disorders Cardiac ischemia/infarction	0.87% 3/346	0.28% 1/351
Cardiac disorders Cardiopulmonary arrest	0.29% 1/346	0.00% 0/351
Cardiac disorders Conduction abnormality, AV Block - 3rd Degree (Complete AV Block)	0.29% 1/346	0.00% 0/351
Cardiac disorders Hypertension	0.29% 1/346	0.00% 0/351
Cardiac disorders Pericardial effusion	0.29% 1/346	0.28% 1/351
Cardiac disorders Supraventricular arrhythmia, Atrial Tach/Paroxysmal AT	0.29% 1/346	0.00% 0/351
Cardiac disorders Supraventricular arrhythmia, Atrial fibrillation	0.58% 2/346	0.28% 1/351
Ear and labyrinth disorders Auditory/Ear - Other	0.29% 1/346	0.00% 0/351
Eye disorders Ocular - Other	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Anorexia	0.87% 3/346	0.57% 2/351
Gastrointestinal disorders Ascites	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders Constipation	0.29% 1/346	0.28% 1/351
Gastrointestinal disorders Dehydration	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Diarrhea	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Dysphagia	0.58% 2/346	0.00% 0/351
Gastrointestinal disorders Esophagitis	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders GI - Other	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders Gastritis	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders Heartburn	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Ileus	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Mucositis (functional/symptomatic), Oral cavity	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Nausea	0.58% 2/346	0.28% 1/351
Gastrointestinal disorders Obstruction, GI, Small bowel NOS	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders Stricture, GI, Biliary tree	0.00% 0/346	0.28% 1/351
Gastrointestinal disorders Stricture, GI, Esophagus	0.29% 1/346	0.00% 0/351
Gastrointestinal disorders Vomiting	0.87% 3/346	0.28% 1/351
General disorders Constitutional symptoms - Other	2.9% 10/346	1.1% 4/351
General disorders Death not associated with CTCAE term, Death NOS	0.58% 2/346	0.00% 0/351
General disorders Death not associated with CTCAE term, Disease progression NOS	5.8% 20/346	3.7% 13/351
General disorders Death not associated with CTCAE term, Multi-Organ Failure	1.2% 4/346	0.28% 1/351
General disorders Fatigue	1.2% 4/346	0.28% 1/351
General disorders Fever	0.29% 1/346	0.28% 1/351
General disorders Pain, Abdomen NOS	0.58% 2/346	0.57% 2/351
General disorders Pain, Back	0.29% 1/346	0.85% 3/351
General disorders Pain, Bone	0.58% 2/346	1.1% 4/351
General disorders Pain, Chest wall	0.58% 2/346	0.85% 3/351
General disorders Pain, Chest/Thorax NOS	0.87% 3/346	0.57% 2/351
General disorders Pain, Extremity - limb	0.00% 0/346	0.57% 2/351
General disorders Pain, Pain NOS	0.29% 1/346	0.00% 0/351
General disorders Pain, Tumor pain	0.29% 1/346	0.28% 1/351
General disorders Weight loss	0.29% 1/346	0.00% 0/351
Hepatobiliary disorders Hepatobiliary - Other	0.29% 1/346	0.28% 1/351
Hepatobiliary disorders Liver dysfunction	0.58% 2/346	0.00% 0/351
Hepatobiliary disorders Pancreatitis	0.00% 0/346	0.28% 1/351
Immune system disorders Allergic reaction	0.29% 1/346	0.00% 0/351
Infections and infestations Infection (Documented clinically), Lung (Pneumonia)	0.29% 1/346	0.28% 1/351
Infections and infestations Infection - Other	0.29% 1/346	0.28% 1/351
Infections and infestations Infection with normal ANC, Bone (Osteomyelitis)	0.29% 1/346	0.00% 0/351
Infections and infestations Infection with normal ANC, Brain (Encephalitis, infectious)	0.29% 1/346	0.00% 0/351
Infections and infestations Infection with normal ANC, Bronchus	0.87% 3/346	0.57% 2/351
Infections and infestations Infection with normal ANC, Lung (Pneumonia)	3.2% 11/346	1.1% 4/351
Infections and infestations Infection with normal ANC, Skin (cellulitis)	0.29% 1/346	0.00% 0/351
Infections and infestations Infection with normal ANC, Upper airway NOS	0.58% 2/346	0.28% 1/351
Infections and infestations Infection with unknown ANC, Lung (Pneumonia)	1.4% 5/346	0.28% 1/351
Infections and infestations Infection with unknown ANC, Upper airway NOS	0.29% 1/346	0.28% 1/351
Metabolism and nutrition disorders Acidosis (metabolic or respiratory)	0.29% 1/346	0.00% 0/351
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/346	0.28% 1/351
Metabolism and nutrition disorders Hyperuricemia	0.29% 1/346	0.00% 0/351
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/346	0.28% 1/351
Metabolism and nutrition disorders Hypokalemia	0.29% 1/346	0.00% 0/351
Metabolism and nutrition disorders Hyponatremia	0.00% 0/346	0.57% 2/351
Musculoskeletal and connective tissue disorders Device/Prosthesis	0.29% 1/346	0.00% 0/351
Musculoskeletal and connective tissue disorders Fracture	0.29% 1/346	0.57% 2/351
Musculoskeletal and connective tissue disorders Muscle weakness, Extremity - lower	0.00% 0/346	0.28% 1/351
Musculoskeletal and connective tissue disorders Muscle weakness, Extremity - upper	0.00% 0/346	0.28% 1/351
Nervous system disorders Apnea	0.29% 1/346	0.00% 0/351
Nervous system disorders CNS ischemia	2.0% 7/346	0.28% 1/351
Nervous system disorders Confusion	0.29% 1/346	0.57% 2/351
Nervous system disorders Dizziness	0.00% 0/346	0.57% 2/351
Nervous system disorders Hydrocephalus	0.00% 0/346	0.28% 1/351
Nervous system disorders Neurology - Other	0.29% 1/346	1.1% 4/351
Nervous system disorders Neuropathy: motor	0.00% 0/346	1.4% 5/351
Nervous system disorders Neuropathy: sensory	0.29% 1/346	0.28% 1/351
Nervous system disorders Pyramidal tract dysfunction	0.00% 0/346	0.28% 1/351
Nervous system disorders Seizure	0.87% 3/346	0.28% 1/351
Nervous system disorders Somnolence	0.29% 1/346	0.00% 0/351
Nervous system disorders Speech impairment	0.29% 1/346	0.00% 0/351
Nervous system disorders Syncope (Fainting)	0.00% 0/346	0.28% 1/351
Renal and urinary disorders Renal - Other	0.29% 1/346	0.00% 0/351
Renal and urinary disorders Renal failure	0.00% 0/346	0.28% 1/351
Renal and urinary disorders Urinary retention	0.58% 2/346	0.00% 0/351
Respiratory, thoracic and mediastinal disorders ARDS	0.00% 0/346	0.57% 2/351
Respiratory, thoracic and mediastinal disorders Chest tube drainage or leak	0.29% 1/346	0.00% 0/351
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/346	0.28% 1/351
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	10.1% 35/346	8.5% 30/351
Respiratory, thoracic and mediastinal disorders Hypoxia	0.29% 1/346	0.00% 0/351
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 4/346	0.28% 1/351
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/346	0.28% 1/351
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.58% 2/346	0.00% 0/351
Respiratory, thoracic and mediastinal disorders Pulmonary - Other	1.4% 5/346	1.1% 4/351
Skin and subcutaneous tissue disorders Dermatology - Other	0.00% 0/346	0.28% 1/351
Skin and subcutaneous tissue disorders Hand-foot skin reaction	2.0% 7/346	0.00% 0/351
Skin and subcutaneous tissue disorders Rash/desquamation	0.58% 2/346	0.00% 0/351
Vascular disorders CNS hemorrhage	0.29% 1/346	0.00% 0/351
Vascular disorders Hemorrhage pulmonary, Bronchopulmonary NOS	0.29% 1/346	0.00% 0/351
Vascular disorders Hemorrhage pulmonary, Lung	0.29% 1/346	0.00% 0/351
Vascular disorders Hemorrhage, GI, Abdomen NOS	0.29% 1/346	0.00% 0/351
Vascular disorders Hemorrhage, GI, Rectum	0.00% 0/346	0.28% 1/351
Vascular disorders Thrombosis/Embolism (vascular access)	0.29% 1/346	0.00% 0/351
Vascular disorders Thrombosis/Thrombus/Embolism	1.4% 5/346	1.7% 6/351
Vascular disorders Vascular - Other	0.29% 1/346	0.00% 0/351
General disorders Pain, Head/Headache	0.29% 1/346	0.00% 0/351

Other adverse events

Measure	Sorafenib (Nexavar, BAY43-9006) n=346 participants at risk Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)	Placebo n=351 participants at risk Participants received 2 tablets of placebo orally twice daily (BID)
Blood and lymphatic system disorders Hemoglobin	6.9% 24/346	4.8% 17/351
Cardiac disorders Hypertension	19.7% 68/346	4.6% 16/351
Gastrointestinal disorders Anorexia	30.1% 104/346	17.4% 61/351
Gastrointestinal disorders Constipation	14.2% 49/346	13.7% 48/351
Gastrointestinal disorders Diarrhea	35.5% 123/346	12.0% 42/351
Gastrointestinal disorders Mucositis (functional/symptomatic), Oral cavity	16.8% 58/346	4.3% 15/351
Gastrointestinal disorders Nausea	16.8% 58/346	16.0% 56/351
Gastrointestinal disorders Vomiting	14.7% 51/346	12.5% 44/351
General disorders Fatigue	36.1% 125/346	27.6% 97/351
General disorders Fever	11.3% 39/346	5.1% 18/351
General disorders Insomnia	8.7% 30/346	5.7% 20/351
General disorders Pain, Abdomen NOS	9.8% 34/346	3.4% 12/351
General disorders Pain, Back	9.5% 33/346	10.5% 37/351
General disorders Pain, Bone	5.5% 19/346	8.0% 28/351
General disorders Pain, Chest wall	6.6% 23/346	5.1% 18/351
General disorders Pain, Chest/Thorax NOS	12.7% 44/346	9.1% 32/351
General disorders Pain, Extremity - limb	7.2% 25/346	5.7% 20/351
General disorders Pain, Head/Headache	11.0% 38/346	7.4% 26/351
General disorders Pain, Joint	8.7% 30/346	6.3% 22/351
General disorders Pain, Muscle	5.2% 18/346	4.0% 14/351
General disorders Weight loss	12.4% 43/346	4.8% 17/351
Infections and infestations Infection with normal ANC, Upper airway NOS	4.3% 15/346	5.4% 19/351
Metabolism and nutrition disorders ALT	7.5% 26/346	2.8% 10/351
Metabolism and nutrition disorders AST	6.9% 24/346	2.0% 7/351
Metabolism and nutrition disorders Hypoalbuminemia	5.2% 18/346	2.6% 9/351
Metabolism and nutrition disorders Hypokalemia	6.9% 24/346	0.85% 3/351
Metabolism and nutrition disorders Metabolic/Lab - Other	5.2% 18/346	1.1% 4/351
Metabolism and nutrition disorders Proteinuria	7.8% 27/346	1.7% 6/351
Nervous system disorders Dizziness	5.8% 20/346	3.4% 12/351
Nervous system disorders Neuropathy: sensory	5.2% 18/346	7.1% 25/351
Respiratory, thoracic and mediastinal disorders Cough	22.8% 79/346	19.1% 67/351
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	24.0% 83/346	24.5% 86/351
Respiratory, thoracic and mediastinal disorders Voice changes	5.2% 18/346	1.4% 5/351
Skin and subcutaneous tissue disorders Alopecia	18.8% 65/346	1.1% 4/351
Skin and subcutaneous tissue disorders Hand-foot skin reaction	54.9% 190/346	6.0% 21/351
Skin and subcutaneous tissue disorders Pruritus	6.9% 24/346	4.3% 15/351
Skin and subcutaneous tissue disorders Rash/desquamation	40.5% 140/346	12.3% 43/351

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator must discuss and obtain written consent of the sponsor on the intended publication. The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of the submission in order to obtain approval.
• Publication restrictions are in place

Restriction type: OTHER