ID

22137

Description

Study part: Week 2 (Day 7) Infusion. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Keywords

Versions (1)
  1. 5/21/17 5/21/17 -
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Roche

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May 21, 2017

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Creative Commons BY-NC 3.0
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WEEK 2 (DAY 7) INFUSION Roche H0650g Breast Cancer

English

WEEK 2 (DAY 7) INFUSION

1 forms  
PRIOR TO INFUSION:
Description

PRIOR TO INFUSION:

Alias
UMLS CUI-1
C0574032
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Data type

integer

Alias
UMLS CUI [1]
C2348585
1. OBTAIN SAMPLES FOR CENTRAL LABORATORY ASSESSMENTS AS WELL AS PK/Ab, SHED ANTIGEN, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES. ATTACH COPY OF LABORATORY REPORT.
Description

ASSESSMENT LABORATORY

Data type

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0022877
2. IS A SYMPTOM-DIRECTED PHYSICAL EXAMINATION REQUIRED?
Description

IF YES, COMPLETE THE APPROPRIATE PAGES IN THE "UNSCHEDULED VISIT" SECTION OF THE CASE REPORT FORM.

Data type

boolean

Alias
UMLS CUI [1]
C0031809
3. WEIGHT:
Description

WEIGHT

Data type

float

Measurement units
  • lb
Alias
UMLS CUI [1]
C0005910
lb
3. WEIGHT:
Description

WEIGHT

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
KARNOFSKY STATUS:
Description

KARNOFSKY STATUS

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0206065
%
4 . WERE ANY ADVERSE EVENTS OR TOXICITIES NOTED? 1
Description

IF YES, PLEASE COMPLETE INFORMATION IN THE ADVERSE EVENTS SECTION AT WEEK 8, OR IN THE SERIOUS AE SECTION AT THE END OF THE CRF, IF APPLICABLE.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0013221
5. RECORD ALL NEW MEDICATIONS, CHANGES IN DOSE, OR DISCONTINUED MEDICATIONS SINCE BASELINE ON THE MEDICATIONS PAGE AT WEEK 24. NOTE ALL RADIOTHERAPY AT THE END OF THE CRF.
Description

medication; radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C1522449
INFUSION DATA:
Description

INFUSION DATA:

Alias
UMLS CUI-1
C0574032
1. DID THE PATIENT RECEIVE THE WEEKLY INFUSION?
Description

infusion

Data type

boolean

Alias
UMLS CUI [1]
C0574032
IF NO, SPECIFY REASON:
Description

reason

Data type

text

Alias
UMLS CUI [1]
C0392360
DATE OF INFUSION:
Description

date of infusion

Data type

date

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0011008
START TIME OF INFUSION:
Description

start time infusion

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0574032
STOP TIME OF INFUSION:
Description

stop time infusion

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
TOTAL DOSE RECEIVED:
Description

medication dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
LABEL (LOT) USED:
Description

label

Data type

text

Alias
UMLS CUI [1]
C0013191
VITAL SIGNS
Description

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- TEMPERATURE
Description

temperature before infusion

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0585032
UMLS CUI [1,3]
C0574032
°C
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- TEMPERATURE
Description

temperature before infusion

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0585032
UMLS CUI [1,3]
C0574032
°F
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- DIASTOLIC BLOOD PRESSURE
Description

DIASTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-HEART RATE
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-RESP. RATE
Description

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
2. END OF INFUSION (COLLECT PK SAMPLES)-TEMPERATURE
Description

TEMPERATURE end infusion

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0574032
°C
2. END OF INFUSION (COLLECT PK SAMPLES)-TEMPERATURE
Description

TEMPERATURE end infusion

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0574032
°F
2. END OF INFUSION (COLLECT PK SAMPLES)- SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. END OF INFUSION (COLLECT PK SAMPLES)-DIASTOLIC BLOOD PRESSURE
Description

DIASTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. END OF INFUSION (COLLECT PK SAMPLES)- HEART RATE
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
2. END OF INFUSION (COLLECT PK SAMPLES)- RESP. RATE
Description

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
3. 1 HOUR POST -INFUSION- TEMPERATURE
Description

Post-Therapy Infusion TEMPERATURE

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C1882428
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0039476
°C
3. 1 HOUR POST -INFUSION- TEMPERATURE
Description

Post-Therapy Infusion TEMPERATURE

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1,1]
C1882428
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0039476
°F
3. 1 HOUR POST -INFUSION- SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. 1 HOUR POST -INFUSION- DIASTOLIC BLOOD PRESSURE
Description

DIASTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. 1 HOUR POST -INFUSION- HEART RATE
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
3. 1 HOUR POST -INFUSION- RESP. RATE
Description

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
4. FOLLOW-UP #1 - TIME OF ASSESSMENT
Description

Time assessment Follow up

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522577
4. FOLLOW-UP #1 - TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
4. FOLLOW-UP #1 - TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1]
C0039476
°F
4. FOLLOW-UP #1 SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
4.FOLLOW-UP #1 DIASTOLIC BLOOD PRESSURE
Description

DIASTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
4. FOLLOW-UP #1 HEART RATE
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
4. FOLLOW-UP #1 RESP. RATE
Description

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
5. FOLLOW-UP #2 - TIME OF ASSESSMENT
Description

Time assessment Follow up

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522577
5. FOLLOW-UP #2 - TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
5. FOLLOW-UP #2 - TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1]
C0039476
°F
5.FOLLOW-UP #2 - SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
5. FOLLOW-UP #2 - DIASTOLIC BLOOD PRESSURE
Description

DIASTOLIC BLOOD PRESSURE

Data type

integer

Alias
UMLS CUI [1]
C0428883
5. FOLLOW-UP #2 - HEART RATE
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
5.FOLLOW-UP #2 - RESP. RATE
Description

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
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Similar models

WEEK 2 (DAY 7) INFUSION

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PRIOR TO INFUSION:
C0574032 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
ASSESSMENT LABORATORY
Item
1. OBTAIN SAMPLES FOR CENTRAL LABORATORY ASSESSMENTS AS WELL AS PK/Ab, SHED ANTIGEN, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES. ATTACH COPY OF LABORATORY REPORT.
boolean
C0220825 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
PHYSICAL EXAMINATION
Item
2. IS A SYMPTOM-DIRECTED PHYSICAL EXAMINATION REQUIRED?
boolean
C0031809 (UMLS CUI [1])
WEIGHT
Item
3. WEIGHT:
float
C0005910 (UMLS CUI [1])
WEIGHT
Item
3. WEIGHT:
float
C0005910 (UMLS CUI [1])
KARNOFSKY STATUS
Item
KARNOFSKY STATUS:
float
C0206065 (UMLS CUI [1])
adverse events; toxicities
Item
4 . WERE ANY ADVERSE EVENTS OR TOXICITIES NOTED? 1
boolean
C0877248 (UMLS CUI [1])
C0013221 (UMLS CUI [2])
medication; radiotherapy
Item
5. RECORD ALL NEW MEDICATIONS, CHANGES IN DOSE, OR DISCONTINUED MEDICATIONS SINCE BASELINE ON THE MEDICATIONS PAGE AT WEEK 24. NOTE ALL RADIOTHERAPY AT THE END OF THE CRF.
boolean
C0013227 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Item Group
INFUSION DATA:
C0574032 (UMLS CUI-1)
infusion
Item
1. DID THE PATIENT RECEIVE THE WEEKLY INFUSION?
boolean
C0574032 (UMLS CUI [1])
reason
Item
IF NO, SPECIFY REASON:
text
C0392360 (UMLS CUI [1])
date of infusion
Item
DATE OF INFUSION:
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
start time infusion
Item
START TIME OF INFUSION:
time
C1301880 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
stop time infusion
Item
STOP TIME OF INFUSION:
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
medication dose
Item
TOTAL DOSE RECEIVED:
float
C3174092 (UMLS CUI [1])
label
Item
LABEL (LOT) USED:
text
C0013191 (UMLS CUI [1])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
temperature before infusion
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- TEMPERATURE
float
C0005903 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
temperature before infusion
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- TEMPERATURE
float
C0005903 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
SYSTOLIC BLOOD PRESSURE
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
DIASTOLIC BLOOD PRESSURE
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)- DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-HEART RATE
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
1. PRE-INFUSION (COLLECT PK/Ab, SHED Ag, LYMPHOCYTE PHENOTYPING AND SPECIAL STUDIES SAMPLES)-RESP. RATE
integer
C0231832 (UMLS CUI [1])
TEMPERATURE end infusion
Item
2. END OF INFUSION (COLLECT PK SAMPLES)-TEMPERATURE
float
C0039476 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
TEMPERATURE end infusion
Item
2. END OF INFUSION (COLLECT PK SAMPLES)-TEMPERATURE
float
C0039476 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
SYSTOLIC BLOOD PRESSURE
Item
2. END OF INFUSION (COLLECT PK SAMPLES)- SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
DIASTOLIC BLOOD PRESSURE
Item
2. END OF INFUSION (COLLECT PK SAMPLES)-DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
2. END OF INFUSION (COLLECT PK SAMPLES)- HEART RATE
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
2. END OF INFUSION (COLLECT PK SAMPLES)- RESP. RATE
integer
C0231832 (UMLS CUI [1])
Post-Therapy Infusion TEMPERATURE
Item
3. 1 HOUR POST -INFUSION- TEMPERATURE
float
C1882428 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Post-Therapy Infusion TEMPERATURE
Item
3. 1 HOUR POST -INFUSION- TEMPERATURE
float
C1882428 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
SYSTOLIC BLOOD PRESSURE
Item
3. 1 HOUR POST -INFUSION- SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
DIASTOLIC BLOOD PRESSURE
Item
3. 1 HOUR POST -INFUSION- DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
3. 1 HOUR POST -INFUSION- HEART RATE
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
3. 1 HOUR POST -INFUSION- RESP. RATE
integer
C0231832 (UMLS CUI [1])
Time assessment Follow up
Item
4. FOLLOW-UP #1 - TIME OF ASSESSMENT
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
TEMPERATURE
Item
4. FOLLOW-UP #1 - TEMPERATURE
float
C0039476 (UMLS CUI [1])
TEMPERATURE
Item
4. FOLLOW-UP #1 - TEMPERATURE
float
C0039476 (UMLS CUI [1])
SYSTOLIC BLOOD PRESSURE
Item
4. FOLLOW-UP #1 SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
DIASTOLIC BLOOD PRESSURE
Item
4.FOLLOW-UP #1 DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
4. FOLLOW-UP #1 HEART RATE
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
4. FOLLOW-UP #1 RESP. RATE
integer
C0231832 (UMLS CUI [1])
Time assessment Follow up
Item
5. FOLLOW-UP #2 - TIME OF ASSESSMENT
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
TEMPERATURE
Item
5. FOLLOW-UP #2 - TEMPERATURE
float
C0039476 (UMLS CUI [1])
TEMPERATURE
Item
5. FOLLOW-UP #2 - TEMPERATURE
float
C0039476 (UMLS CUI [1])
SYSTOLIC BLOOD PRESSURE
Item
5.FOLLOW-UP #2 - SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
DIASTOLIC BLOOD PRESSURE
Item
5. FOLLOW-UP #2 - DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
5. FOLLOW-UP #2 - HEART RATE
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
5.FOLLOW-UP #2 - RESP. RATE
integer
C0231832 (UMLS CUI [1])
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