## Protocol Section
### Identification Module
**NCT ID:** NCT00454779

**Brief Title:** PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

**Official Title:** A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

#### Organization Study ID Info
**ID:** 20050236
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2014-01-01

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2011-08-23

**Type:** ESTIMATED

**Disp First Submit Date:** 2011-08-16
**Disp First Submit QC Date:** 2011-08-16

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-17

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-06-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-02-07

**Type:** ESTIMATED

**Results First Submit Date:** 2013-10-11

**Results First Submit QC Date:** 2014-01-08

#### Start Date
**Date:** 2007-01-01

**Type:** ACTUAL

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2007-04-02
**Type:** ESTIMATED
**Study First Submit Date:** 2007-03-29
**Study First Submit QC Date:** 2007-03-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

### Conditions Module

**Conditions:**

- Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

**Keywords:**

- SCCHNC

- Metastatic

- Recurrent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 113

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Panitumumab + Docetaxel + Cisplatin

**Intervention Names:**

- Drug: Panitumumab

- Drug: Cisplatin

- Drug: Docetaxel

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** control

**Intervention Names:**

- Drug: Cisplatin

- Drug: Docetaxel

**Label:** Arm 2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 2

**Description:** chemotherapy arm

**Name:** Cisplatin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 1

**Description:** experimental arm

**Name:** Panitumumab

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Arm 2

**Description:** chemotherapy arm

**Name:** Docetaxel

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Arm 1

**Description:** experimental arm

**Name:** Cisplatin

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Arm 1

**Description:** experimental arm

**Name:** Docetaxel

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.

**Measure:** Progression Free Survival (PFS) During the First-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months

#### Secondary Outcomes

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.

**Measure:** Overall Response Rate (ORR) During the First-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

**Measure:** Rate of Disease Control (RDC) During the First-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months

**Description:** Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

**Measure:** Duration of Response (DOR) During the First-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months

**Description:** Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

**Measure:** Time to Response (TTR) During the First-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months

**Description:** Time from the date of randomization to the date of death during the entire study

**Measure:** Overall Survival (OS) for the First-line Treatment

**Time Frame:** Until death, up to 67 months

**Description:** The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.

**Measure:** Progression Free Survival (PFS) During the Second-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.

**Measure:** Overall Response Rate (ORR) During the Second-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

**Measure:** Rate of Disease Control (RDC) During the Second-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months

**Description:** Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

**Measure:** Duration of Response (DOR) During the Second-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months

**Description:** Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)

**Measure:** Time to Response (TTR) During the Second-line Treatment Phase

**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months

**Description:** Time from the first dose of panitumumab monotherapy to the date of death during the entire study

**Measure:** Overall Survival (OS) for the Second-line Treatment

**Time Frame:** Until death, up to 57 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
* Measurable disease by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Age: 18 years or older
* Adequate hematologic, renal, metabolic, hepatic \& thyroid function

Exclusion Criteria:

* Prior systemic treatment for metastatic and/or recurrent SCCHN
* CNS metastases, or nasopharyngeal carcinoma
* History of interstitial lung disease
* History of another primary cancer
* Any co-morbid disease that would increase risk of toxicity

  * Active infection requiring systemic treatment
  * Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**Facility:** Research Site

**State:** Arizona

**Zip:** 85715

**Location 2:**

**City:** Jonesboro

**Country:** United States

**Facility:** Research Site

**State:** Arkansas

**Zip:** 72401

**Location 3:**

**City:** Duarte

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 91010

**Location 4:**

**City:** La Jolla

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 92037

**Location 5:**

**City:** La Verne

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 91750

**Location 6:**

**City:** Los Angeles

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 90095

**Location 7:**

**City:** Santa Cruz

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 95065

**Location 8:**

**City:** Aurora

**Country:** United States

**Facility:** Research Site

**State:** Colorado

**Zip:** 80045

**Location 9:**

**City:** Denver

**Country:** United States

**Facility:** Research Site

**State:** Colorado

**Zip:** 80210

**Location 10:**

**City:** Norwich

**Country:** United States

**Facility:** Research Site

**State:** Connecticut

**Zip:** 06360

**Location 11:**

**City:** Newark

**Country:** United States

**Facility:** Research Site

**State:** Delaware

**Zip:** 19713

**Location 12:**

**City:** Washington

**Country:** United States

**Facility:** Research Site

**State:** District of Columbia

**Zip:** 20007

**Location 13:**

**City:** Washington

**Country:** United States

**Facility:** Research Site

**State:** District of Columbia

**Zip:** 20010

**Location 14:**

**City:** Washington

**Country:** United States

**Facility:** Research Site

**State:** District of Columbia

**Zip:** 20037

**Location 15:**

**City:** Washington

**Country:** United States

**Facility:** Research Site

**State:** District of Columbia

**Zip:** 20422

**Location 16:**

**City:** Lakeland

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 33805

**Location 17:**

**City:** Miami

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 33176

**Location 18:**

**City:** New Port Richey

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 34655

**Location 19:**

**City:** Orlando

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 32806

**Location 20:**

**City:** Athens

**Country:** United States

**Facility:** Research Site

**State:** Georgia

**Zip:** 30607

**Location 21:**

**City:** Griffin

**Country:** United States

**Facility:** Research Site

**State:** Georgia

**Zip:** 30224

**Location 22:**

**City:** Marietta

**Country:** United States

**Facility:** Research Site

**State:** Georgia

**Zip:** 30060

**Location 23:**

**City:** Centralia

**Country:** United States

**Facility:** Research Site

**State:** Illinois

**Zip:** 62801

**Location 24:**

**City:** Elk Grove Village

**Country:** United States

**Facility:** Research Site

**State:** Illinois

**Zip:** 60007

**Location 25:**

**City:** Evanston

**Country:** United States

**Facility:** Research Site

**State:** Illinois

**Zip:** 60201

**Location 26:**

**City:** Park Ridge

**Country:** United States

**Facility:** Research Site

**State:** Illinois

**Zip:** 60068

**Location 27:**

**City:** Zion

**Country:** United States

**Facility:** Research Site

**State:** Illinois

**Zip:** 60099

**Location 28:**

**City:** Wichita

**Country:** United States

**Facility:** Research Site

**State:** Kansas

**Zip:** 67214

**Location 29:**

**City:** Ashland

**Country:** United States

**Facility:** Research Site

**State:** Kentucky

**Zip:** 41101

**Location 30:**

**City:** Lexington

**Country:** United States

**Facility:** Research Site

**State:** Kentucky

**Zip:** 40536

**Location 31:**

**City:** Louisville

**Country:** United States

**Facility:** Research Site

**State:** Kentucky

**Zip:** 40202-1703

**Location 32:**

**City:** Louisville

**Country:** United States

**Facility:** Research Site

**State:** Kentucky

**Zip:** 40202

**Location 33:**

**City:** Paducah

**Country:** United States

**Facility:** Research Site

**State:** Kentucky

**Zip:** 42003

**Location 34:**

**City:** Baltimore

**Country:** United States

**Facility:** Research Site

**State:** Maryland

**Zip:** 21204

**Location 35:**

**City:** Baltimore

**Country:** United States

**Facility:** Research Site

**State:** Maryland

**Zip:** 21237

**Location 36:**

**City:** Frederick

**Country:** United States

**Facility:** Research Site

**State:** Maryland

**Zip:** 21701

**Location 37:**

**City:** Boston

**Country:** United States

**Facility:** Research Site

**State:** Massachusetts

**Zip:** 02114

**Location 38:**

**City:** Ann Arbor

**Country:** United States

**Facility:** Research Site

**State:** Michigan

**Zip:** 48106-0995

**Location 39:**

**City:** Lansing

**Country:** United States

**Facility:** Research Site

**State:** Michigan

**Zip:** 48910

**Location 40:**

**City:** Pascagoula

**Country:** United States

**Facility:** Research Site

**State:** Mississippi

**Zip:** 39581

**Location 41:**

**City:** Columbia

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 65201

**Location 42:**

**City:** Jefferson City

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 65109

**Location 43:**

**City:** Saint Louis

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 63110-1093

**Location 44:**

**City:** Saint Louis

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 63110

**Location 45:**

**City:** Billings

**Country:** United States

**Facility:** Research Site

**State:** Montana

**Zip:** 59102

**Location 46:**

**City:** Omaha

**Country:** United States

**Facility:** Research Site

**State:** Nebraska

**Zip:** 68114

**Location 47:**

**City:** Henderson

**Country:** United States

**Facility:** Research Site

**State:** Nevada

**Zip:** 59074

**Location 48:**

**City:** Hackensack

**Country:** United States

**Facility:** Research Site

**State:** New Jersey

**Zip:** 07601

**Location 49:**

**City:** Binghamton

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 13905

**Location 50:**

**City:** Bronx

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10457

**Location 51:**

**City:** Bronx

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10467

**Location 52:**

**City:** Mineola

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 11501

**Location 53:**

**City:** New York

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10003

**Location 54:**

**City:** New York

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10032

**Location 55:**

**City:** Nyack

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10960

**Location 56:**

**City:** Rochester

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 14623

**Location 57:**

**City:** Syracuse

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 13210

**Location 58:**

**City:** Canton

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 44718

**Location 59:**

**City:** Cincinnati

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 45236

**Location 60:**

**City:** Dayton

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 45420

**Location 61:**

**City:** Toledo

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 43614

**Location 62:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Research Site

**State:** Oklahoma

**Zip:** 73104

**Location 63:**

**City:** Langhorne

**Country:** United States

**Facility:** Research Site

**State:** Pennsylvania

**Zip:** 19047

**Location 64:**

**City:** Philadelphia

**Country:** United States

**Facility:** Research Site

**State:** Pennsylvania

**Zip:** 19107

**Location 65:**

**City:** Scranton

**Country:** United States

**Facility:** Research Site

**State:** Pennsylvania

**Zip:** 18510

**Location 66:**

**City:** Charleston

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29406

**Location 67:**

**City:** Charleston

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29425

**Location 68:**

**City:** Greenville

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29615

**Location 69:**

**City:** Memphis

**Country:** United States

**Facility:** Research Site

**State:** Tennessee

**Zip:** 38120

**Location 70:**

**City:** Arlington

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 76012

**Location 71:**

**City:** Corpus Christi

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 78405

**Location 72:**

**City:** Corpus Christi

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 78412

**Location 73:**

**City:** Dallas

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75201

**Location 74:**

**City:** Dallas

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75230

**Location 75:**

**City:** Dallas

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75234

**Location 76:**

**City:** Galveston

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 77555-0158

**Location 77:**

**City:** San Antonio

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 78229

**Location 78:**

**City:** Abingdon

**Country:** United States

**Facility:** Research Site

**State:** Virginia

**Zip:** 24211

**Location 79:**

**City:** Chesapeake

**Country:** United States

**Facility:** Research Site

**State:** Virginia

**Zip:** 23320

**Location 80:**

**City:** Morgantown

**Country:** United States

**Facility:** Research Site

**State:** West Virginia

**Zip:** 26506

**Location 81:**

**City:** Madison

**Country:** United States

**Facility:** Research Site

**State:** Wisconsin

**Zip:** 53792

**Location 82:**

**City:** Marshfield

**Country:** United States

**Facility:** Research Site

**State:** Wisconsin

**Zip:** 54449

**Location 83:**

**City:** Graz

**Country:** Austria

**Facility:** Research Site

**Zip:** 8036

**Location 84:**

**City:** Leoben

**Country:** Austria

**Facility:** Research Site

**Zip:** 8700

**Location 85:**

**City:** Linz

**Country:** Austria

**Facility:** Research Site

**Zip:** 4010

**Location 86:**

**City:** Wien

**Country:** Austria

**Facility:** Research Site

**Zip:** 1090

**Location 87:**

**City:** Brasschaat

**Country:** Belgium

**Facility:** Research Site

**Zip:** 2930

**Location 88:**

**City:** Brugge

**Country:** Belgium

**Facility:** Research Site

**Zip:** 8000

**Location 89:**

**City:** Kortrijk

**Country:** Belgium

**Facility:** Research Site

**Zip:** 8500

**Location 90:**

**City:** Libramont

**Country:** Belgium

**Facility:** Research Site

**Zip:** 6800

**Location 91:**

**City:** Liege

**Country:** Belgium

**Facility:** Research Site

**Zip:** 4000

**Location 92:**

**City:** Ottignies

**Country:** Belgium

**Facility:** Research Site

**Zip:** 1340

**Location 93:**

**City:** Wilrijk

**Country:** Belgium

**Facility:** Research Site

**Zip:** 2610

**Location 94:**

**City:** Brno

**Country:** Czechia

**Facility:** Research Site

**Zip:** 656 53

**Location 95:**

**City:** Praha 5

**Country:** Czechia

**Facility:** Research Site

**Zip:** 150 06

**Location 96:**

**City:** Znojmo

**Country:** Czechia

**Facility:** Research Site

**Zip:** 669 02

**Location 97:**

**City:** Angers

**Country:** France

**Facility:** Research Site

**Zip:** 49933

**Location 98:**

**City:** Lens cedex

**Country:** France

**Facility:** Research Site

**Zip:** 62307

**Location 99:**

**City:** Perpignan

**Country:** France

**Facility:** Research Site

**Zip:** 66000

**Location 100:**

**City:** Vandoeuvre les Nancy

**Country:** France

**Facility:** Research Site

**Zip:** 54511

**Location 101:**

**City:** Kaunas

**Country:** Lithuania

**Facility:** Research Site

**Zip:** 45434

**Location 102:**

**City:** Vilnius

**Country:** Lithuania

**Facility:** Research Site

**Zip:** 08660

**Location 103:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** Research Site

**Zip:** 00935

**Location 104:**

**City:** Banska Bystrica

**Country:** Slovakia

**Facility:** Research Site

**Zip:** 974 01

**Location 105:**

**City:** Bratislava

**Country:** Slovakia

**Facility:** Research Site

**Zip:** 812 50

**Location 106:**

**City:** Nove Zamky

**Country:** Slovakia

**Facility:** Research Site

**Zip:** 940 34

**Location 107:**

**City:** Presov

**Country:** Slovakia

**Facility:** Research Site

**Zip:** 080 01

**Location 108:**

**City:** Spisska Nova Ves

**Country:** Slovakia

**Facility:** Research Site

**Zip:** 052 01

**Location 109:**

**City:** Santander

**Country:** Spain

**Facility:** Research Site

**State:** Cantabria

**Zip:** 39008

**Location 110:**

**City:** Barcelona

**Country:** Spain

**Facility:** Research Site

**State:** Cataluña

**Zip:** 08025

**Location 111:**

**City:** Girona

**Country:** Spain

**Facility:** Research Site

**State:** Cataluña

**Zip:** 17007

**Location 112:**

**City:** L Hospitalet De Llobregat

**Country:** Spain

**Facility:** Research Site

**State:** Cataluña

**Zip:** 08907

**Location 113:**

**City:** Valencia

**Country:** Spain

**Facility:** Research Site

**State:** Comunidad Valenciana

**Zip:** 46009

**Location 114:**

**City:** Madrid

**Country:** Spain

**Facility:** Research Site

**Zip:** 28040

#### Overall Officials

**Official 1:**

**Affiliation:** Amgen

**Name:** MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

#### See Also Links

**Label:** AmgenTrials clinical trials website

**URL:** http://www.amgentrials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002294

- Term: Carcinoma, Squamous Cell

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Head and Neck Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M1689

- Name: Squamous Cell Carcinoma of Head and Neck

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma of Head and Neck

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000077195

- Term: Squamous Cell Carcinoma of Head and Neck

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6182

- Name: Cisplatin

- Relevance: HIGH

- As Found: High

- ID: M1668

- Name: Docetaxel

- Relevance: HIGH

- As Found: Physical

- ID: M1822

- Name: Panitumumab

- Relevance: HIGH

- As Found: 2/day

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002945

- Term: Cisplatin

- ID: D000077143

- Term: Docetaxel

- ID: D000077544

- Term: Panitumumab

### Misc Info Module

#### Removed Countries

- Country: Czech Republic

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

#### Event Groups

**Group ID:** EG000

**Title:** Panitumumab Plus Chemotherapy

**Description:** Panitumumab + Docetaxel + Cisplatin, experiment

**ID:** EG000

**Other Num Affected:** 54

**Other Num at Risk:** 56

**Serious Number Affected:** 34

**Serious Number At Risk:** 56

**Title:** Panitumumab Plus Chemotherapy

**Group ID:** EG001

**Title:** Chemotherapy Alone

**Description:** Docetaxel + Cisplatin, control

**ID:** EG001

**Other Num Affected:** 53

**Other Num at Risk:** 55

**Serious Number Affected:** 27

**Serious Number At Risk:** 55

**Title:** Chemotherapy Alone

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Tinnitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Lacrimation increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Mouth ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Face oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

**Term:** Cachexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypocalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pain in jaw

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Nocturia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Decubitus ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dermatitis acneiform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Nail disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Skin exfoliation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 55

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 55

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 55

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Arteriosclerosis coronary artery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Aphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Aphthous stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 55

**Term:** Duodenal ulcer perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 55

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 55

**Term:** Oral cavity fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 55

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Device dislocation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Localised oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 55

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Abdominal abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Beta haemolytic streptococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Fungaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Neutropenic sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Oral infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Osteomyelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 55

**Term:** Pneumonia staphylococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Pseudomonal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Pseudomonas infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Staphylococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 55

**Term:** Staphylococcal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Stenotrophomonas infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Arterial injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Feeding tube complication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Humerus fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Post procedural discharge

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Post procedural haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Sternal fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Blood creatine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** International normalised ratio increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Transaminases increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 55

**Term:** Electrolyte imbalance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hypernatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hypocalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 55

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Musculoskeletal chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Rhabdomyolysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Head and neck cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Malignant ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Neoplasm malignant

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Neoplasm progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Tumour haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Tumour ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Acute prerenal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 55

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Interstitial lung disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 55

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Arterial haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 56

**Group ID:** EG001

**Num At Risk:** 55

**Time Frame:** The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date of the first-line treatment. The median time frame is 4.5 months for Panitumumab Plus Chemotherapy arm and 4.4 months for Chemotherapy Alone arm.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 56

**Group ID:** BG001

**Value:** 57

**Group ID:** BG002

**Value:** 113

**Units:** Participants

### Group

**ID:** BG000

**Title:** Panitumumab Plus Chemotherapy

**Description:** Panitumumab + Docetaxel + Cisplatin, experiment

### Group

**ID:** BG001

**Title:** Chemotherapy Alone

**Description:** Docetaxel + Cisplatin, control

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.6

**Value:** 58.2

#### Measurement

**Group ID:** BG001

**Spread:** 7.4

**Value:** 58.9

#### Measurement

**Group ID:** BG002

**Spread:** 8.0

**Value:** 58.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 47

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 99

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Amgen Inc.
**Phone:** 866-572-6436
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.395
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.002
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.051
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.629
**Statistical Comment:** Stratified by IVRS randomization factors
**Statistical Method:** Regression, Cox
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.048
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Stratified by IVRS randomization factors
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -11.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 24.12
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.23
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.57
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 3.33
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.37
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -8.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 23.85
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 7.78
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.62
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 5.26
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.76
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.709
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.717
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.663
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.103
**Statistical Comment:** Stratified by IVRS randomization factors
**Statistical Method:** Regression, Cox
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.666
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Stratified by IVRS randomization factors
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.7
- **Spread:** 
- **Upper Limit:** 8.3
- **Value:** 6.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.1
- **Spread:** 
- **Upper Limit:** 6.8
- **Value:** 5.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30.73
- **Spread:** 
- **Upper Limit:** 57.73
- **Value:** 44.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.99
- **Spread:** 
- **Upper Limit:** 50.52
- **Value:** 37.25
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 70.06
- **Spread:** 
- **Upper Limit:** 91.48
- **Value:** 80.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 60.30
- **Spread:** 
- **Upper Limit:** 84.80
- **Value:** 72.55
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.7
- **Spread:** 
- **Upper Limit:** 11.1
- **Value:** 8.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 7.2
- **Value:** 5.1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.9
- **Upper Limit:** 
- **Value:** 8.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.1
- **Upper Limit:** 
- **Value:** 10.6
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 18.5
- **Value:** 12.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.8
- **Spread:** 
- **Upper Limit:** 22.9
- **Value:** 13.8
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.5
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 4.2
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.17
- **Spread:** 
- **Upper Limit:** 25.50
- **Value:** 13.33
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 35.48
- **Spread:** 
- **Upper Limit:** 71.19
- **Value:** 53.33
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** Median is not reached due to censoring.
- **Group ID:** OG001
- **Lower Limit:** 5.1
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.6
- **Upper Limit:** 
- **Value:** 10.6
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.5
- **Spread:** 
- **Upper Limit:** 13.2
- **Value:** 8.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months
**Title:** Progression Free Survival (PFS) During the First-line Treatment Phase
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 2
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** all randomized subjects \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months
**Title:** Overall Response Rate (ORR) During the First-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 3
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** all randomized subjects \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months
**Title:** Rate of Disease Control (RDC) During the First-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 4
**Description:** Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months
**Title:** Duration of Response (DOR) During the First-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 5
**Description:** Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 67 months
**Title:** Time to Response (TTR) During the First-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Weeks
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 6
**Description:** Time from the date of randomization to the date of death during the entire study
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)
**Reporting Status:** POSTED
**Time Frame:** Until death, up to 67 months
**Title:** Overall Survival (OS) for the First-line Treatment
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 7
**Description:** The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months
**Title:** Progression Free Survival (PFS) During the Second-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 8
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months
**Title:** Overall Response Rate (ORR) During the Second-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 9
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months
**Title:** Rate of Disease Control (RDC) During the Second-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 10
**Description:** Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months
**Title:** Duration of Response (DOR) During the Second-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 11
**Description:** Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response
**Reporting Status:** POSTED
**Time Frame:** Every 6 weeks until disease progression or death, up to 57 months
**Title:** Time to Response (TTR) During the Second-line Treatment Phase
**Type:** SECONDARY
**Unit of Measure:** Weeks
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
#### Outcome Measure 12
**Description:** Time from the first dose of panitumumab monotherapy to the date of death during the entire study
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy
**Reporting Status:** POSTED
**Time Frame:** Until death, up to 57 months
**Title:** Overall Survival (OS) for the Second-line Treatment
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** OG000
**Title:** Panitumumab Plus Chemotherapy
##### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** OG001
**Title:** Chemotherapy Alone
### Participant Flow Module
#### Group
**Description:** Panitumumab + Docetaxel + Cisplatin, experiment
**ID:** FG000
**Title:** Panitumumab Plus Chemotherapy
#### Group
**Description:** Docetaxel + Cisplatin, control
**ID:** FG001
**Title:** Chemotherapy Alone
#### Period
**Title:** First-line Treatment Phase
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Ended follow-up prior to analysis
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Ongoing
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 56
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 57
##### Milestone
**Type:** Received Study Medication
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 56
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 55
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 51
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 49
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 8
#### Period
**Title:** Second-line Treatment Phase
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Ended follow-up prior to analysis
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Ongoing
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 30
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Pre-Assignment Details:** The planned number of subjects to enroll was 110. The actual number of subjects enrolled was 113.
**Recruitment Details:** Subjects were enrolled from 29 January 2007 to 1 September 2010.
**Has Results:** True