Trial Outcomes & Findings for Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer (NCT NCT00655876)

Last Updated: 2022-06-14

Results Overview

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

344 participants

Primary outcome timeframe

From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.

Results posted on

2022-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoradiation + Cetuximab External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Overall Study STARTED	168	176
Overall Study COMPLETED	159	169
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemoradiation + Cetuximab External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Overall Study Protocol Violation	9	7

Baseline Characteristics

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoradiation + Cetuximab n=159 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=169 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin	Total n=328 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	146 Participants n=7 Participants	276 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.

Population: Eligible patients \[We have defined "completed" as patients who have data available for analysis\]

Outcome measures

Outcome measures
Measure	Chemoradiation + Cetuximab n=159 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=169 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Overall Survival (24-month Rate Reported)	44.9 percentage of participants Interval 36.9 to 52.5	44.0 percentage of participants Interval 36.4 to 51.4

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.

Population: All eligible patients

Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.

Outcome measures

Outcome measures
Measure	Chemoradiation + Cetuximab n=159 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=169 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Local Failure (24-month Rate Reported)	47 percentage of participants Interval 38.3 to 56.6	48.8 percentage of participants Interval 40.8 to 57.5

SECONDARY outcome

Timeframe: From start of treatment to 90 days from end of treatment

Population: Eligible patients who started study treatment

Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE

Outcome measures

Outcome measures
Measure	Chemoradiation + Cetuximab n=153 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=166 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events	15.7 percentage of participants Interval 10.8 to 22.3	7.8 percentage of participants Interval 4.6 to 12.9

SECONDARY outcome

Timeframe: From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)

Population: Eligible patients who started study treatment and had an endoscopy performed

All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.

Outcome measures

Outcome measures
Measure	Chemoradiation + Cetuximab n=144 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=159 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Endoscopic Complete Response Rate	56.3 percentage of participants	57.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start.

Population: Patients who consented to collection of patient reported outcomes and quality of life (PRO-QOL) data and had FACT-E scores at baseline and corresponding timepoint

The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.

Outcome measures

Outcome measures
Measure	Chemoradiation + Cetuximab n=124 Participants External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab	Chemoradiation n=137 Participants External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment 6-8 weeks post-treatment	36.8 percentage of participants	52.8 percentage of participants
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment 1 year	45.6 percentage of participants	48.3 percentage of participants
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment 2 years	61.3 percentage of participants	44.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start.

Population: The protocol states that this study endpoint will be addressed ONLY if primary outcome results are positive, i.e. support the primary hypothesis of this study. The primary hypothesis was not supported therefore no patients were analyzed for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Chemoradiation + Cetuximab

Serious events: 88 serious events

Other events: 156 other events

Deaths: 0 deaths

Chemoradiation

Serious events: 88 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Chemoradiation + Cetuximab n=162 participants at risk External beam radiation therapy (RT) with concurrent weekly paclitaxel, and cisplatin, a	Chemoradiation n=173 participants at risk External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Esophageal anastomotic leak	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Prolonged intubation after pulmonary resection (>24 hrs after surgery)	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	1.2% 2/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vascular access complication	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Blood disorder	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Febrile neutropenia	2.5% 4/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.7% 3/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin decreased	6.2% 10/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.8% 10/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemolysis	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Arrhythmia	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	4.3% 7/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial flutter	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardiac disorder	1.9% 3/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardiac pain	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Left ventricular failure	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Myocardial ischemia	1.9% 3/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Pericardial effusion	1.2% 2/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Pericarditis	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus tachycardia	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Supraventricular tachycardia	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Ventricular arrhythmia	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal distension	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	2.5% 4/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 4/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Acquired tracheo-oesophageal fistula	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.7% 3/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Colitis	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	6.2% 10/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.5% 6/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal perforation	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal ulcer	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	8.0% 13/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.5% 13/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Enteritis	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal hemorrhage	1.2% 2/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.7% 3/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal mucositis	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal pain	3.1% 5/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.6% 8/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal perforation	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal stenosis	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal ulcer	0.62% 1/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal varices hemorrhage	0.00% 0/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.58% 1/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events
Measure	Chemoradiation + Cetuximab n=162 participants at risk External beam radiation therapy (RT) with concurrent weekly paclitaxel, and cisplatin, a	Chemoradiation n=173 participants at risk External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Blood and lymphatic system disorders Hemoglobin decreased	54.3% 88/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	50.3% 87/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Pericardial effusion	4.9% 8/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.2% 2/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	13.0% 21/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.6% 20/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	35.2% 57/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	27.2% 47/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	33.3% 54/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.2% 35/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dry mouth	5.6% 9/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.2% 9/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	15.4% 25/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.6% 20/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	48.8% 79/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	51.4% 89/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal pain	12.3% 20/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.9% 24/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal stenosis	4.3% 7/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.9% 12/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis	29.0% 47/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	28.3% 49/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal disorder	6.2% 10/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.9% 5/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis oral	17.3% 28/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.2% 9/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	53.7% 87/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	55.5% 96/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	29.0% 47/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	34.7% 60/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chest pain	7.4% 12/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.7% 15/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema limbs	8.0% 13/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.4% 11/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	66.7% 108/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	62.4% 108/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fever	10.5% 17/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.8% 17/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	6.2% 10/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.2% 16/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Hypersensitivity	4.9% 8/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.5% 6/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation	19.1% 31/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	24.9% 43/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	14.2% 23/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.0% 7/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	9.3% 15/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.4% 11/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alkaline phosphatase increased	7.4% 12/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.2% 16/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	14.2% 23/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.4% 18/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Creatinine increased	14.8% 24/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.0% 26/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Hyperbilirubinemia	3.1% 5/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.2% 9/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Laboratory test abnormal	4.9% 8/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.8% 10/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia	60.5% 98/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	48.6% 84/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	17.9% 29/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	17.9% 31/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	36.4% 59/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	30.6% 53/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	37.0% 60/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	36.4% 63/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight loss	66.0% 107/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	56.1% 97/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	35.2% 57/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	22.5% 39/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	29.0% 47/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	21.4% 37/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	32.7% 53/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	31.2% 54/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	3.1% 5/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.8% 10/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	34.0% 55/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	28.9% 50/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	32.1% 52/162 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.2% 35/173 All patients who started study treatment are included, including ineligible patients. (Therefore this patient group differs from Outcome Measure 3, which is restricted to eligible patients.) Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.