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1.Screening
1.1.Inclusion Criteria

Eligible participant has to fullfill all of the following items

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1.2.Exclusion Criteria

Anyone with one of following items or more should be excluded:

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2.Baseline
2.1.General information

Date of signing the informed consent

2018-11-24

Date of birth

2006-11-01 yyyy-mm-dd

Age

12 Years

Education background

Middle school

Occupation

Other

Other (Description)

学生

2.2.Medical history

12 小时

Number of pregnancy

--

Number of delivery

--

If has delivery history, select following items

partus maturus

--

premature delivery

--

abortion

--

Last pregnancy

-- yyyy-mm-dd

Average times of menstrual onset a year

未月经来潮 次/年

Average menstrual cycle

-- 天(days)

Menarche time

-- 岁(years)

The time of last Menstruation

-- 年、月、日(yyyy-mm-dd)

The time of menstrual onset before the last one

-- 年、月、日(yyyy-mm-dd)

-- 年/月/日(yyyy-mm-dd)

Namy of the drug to be allergied

--

2.3.Physical examination

Vulva

Normal

Description in detail for abnormal

--

Vagina

Not examined

Description in detail for abnormal

Uterine neck

Not examined

Description in detail for abnormal

Corpus uteri

Not examined

Description in detail for abnormal

Adnexa uteri

Left side

Not examined

Description in detail for abnormal

Right side

Not examined

Description in detail for abnormal

Weight

58 kg

Hight

1600 mm

Systolic pressure (SP)

102 mmHg

Diastolic pressure

64 mmHg

Temperature

36.5 degree Celsius

Pulse rate

92 次/分

Breath frequency

23 次/分

Doctor signature

刘义彬

Date

2018-11-24 yyyy-mm-dd

2.4.Blood Routine Tests

WBC

8.5 ×109 /L

NEUT%

61.90 %

LY%

29.60 %

MONO%

6.80

RBC

4.51 ×10^12 /L

HGB

132 g/L

PLT

244 ×10^9 /L

Researcher signature

刘义彬

Date

2018-11-24 yyyy-mm-dd

2.5.Urine Routine Test

Acidity and allkalinity

Acidity

pH value

6.0

Urine protein

Negative

Urine red cell

Negative

Urine WBC

Negative

Urine glucos

Negative

Urine Bilirubin

Negative

Urine HCG

Negative

KET

Negative

SG

1.020

UBG

Negative

NIT

Negative

Date of test

2018-11-25 yyyy-mm-dd

2.6.Blood Electrolytes Tests

Date of test

2018-11-25 yyyy-mm-dd

K

4.06 mmol/L

Na

142.1 mmol/L

Cl

104.0 mmol/L

Ca

2.44 mmol/L

P

1.57 mmol/L

2.7.Coagulation Function Tests

Date of examination

2018-11-25 yyyy-mm-dd

Prothrombin time

12.0

Thrombin time (TT)

14.9

Activated partial thromboplastin time (APTT)

31.1

Fibrinogen (FIB)

2.91 g/L

2.8.Serum Liver Function Tests

ALT

8.3 IU/L

AST

13.7 IU/L

GGT

11.0 U/L

Serum bilirubin

8.7 μmol/L

Indirect bilirubin

5.10 umol/L

Direct bilirubin

3.60 umol/L

Serum albumin

47.9 g/L

Serum globulin

26.0 g/L

Serum total protein

73.9 g/L

Date of test

2018-11-25 yyyy-mm-dd

2.9.HBV/HCV/HIV/Syphilis Markers Test
2.2.9.2.9.1、HBV Markers Test

Negative

Date of test

2018-11-25 yyyy-mm-dd

2.2.9.2.9.2、HCV Marker Test

Negative

Date of test

2018-11-25 yyyy-mm-dd

2.2.9.2.9.3、HIV Marker Test

Negative

Date of test

2018-11-25 yyyy-mm-dd

2.2.9.2.9.4、Syphilis Marker Test

Negative

Date of test

2018-11-25 yyyy-mm-dd

2.10.Renel Function Test

SCr

53.0 μmol/L

Blood urea

4.90 mmol/L

Blood uric acid

329.0 μmol/L

Date of test

2018-11-25 yyyy-mm-dd

2.11.D-dimer

D-dimer value

0.25 ug/mL

Date of test

2018-11-25

2.12.hCG Test

Urine pregnancy test

Not tested

Blood HCG concentration

未查 mIU/mL

Date of test

-- yyyy-mm-dd

2.13.Image Examinations
2.2.13.2.13.1、Ultrasound

Size of the ulcer

2.5*2.47*1.83 cm*cm

Uterine echo distribution

Even

Endometrial thickness

4.3 mm

Left ovary size

1.7*1.59 cm ×cm

Shape of Left ovary

Normal

Size of the Ovarian cyst

--

Right ovary size

3.6*3.13*2.96 cm ×cm

Shape of right ovary

Ovarian cyst

Size of Ovarian cyst

2.77cm

Description of other abnormal findings

--

Diagnosis of the Ultrasound B

右卵巢畸胎瘤

Doctor signature

刘义彬

Date of examination

2018-11-25 yyyy-mm-dd

2.2.13.2.13.2、Other examination
2.14.Visual Analogue Scale

Pain Visual Analogue Score

Very pain

2.15.Blood Gas Analysis

PH

7.369

PCO2

38.6 mmHg

P02

56.1 mmHg

SO2

91.4

HCO3

21.9 mmol/l

SBE

-3.0 mmol/l

LAC

0.98 mmol/L

Date of examination

2018-11-24 (yyyy-mm-dd)

3.In the process of the treatment
3.1.Treatment Record

右卵巢

5 cm

°

刘义彬

2018-11-25

4.Follow-up
4.1.D-dimer

D-dimer value

未查 ug/mL

Date of test

未查

4.2.Physical examination

Body temperature

36.5

Systolic pressure (SP)

102 mmHg

Diastolic pressure (DP)

64 mmHg

Heart Rate, HR

92 次/分

Pulse

92 次/秒

4.3.Blood Routine Tests

WBC

6.50 ×109 /L

NEUT%

56.40 %

LY%

31.10 %

MONO%

9.30

RBC

4.38 ×10^12 /L

HGB

131 g/L

PLT

220 ×10^9 /L

Date

2018-11-27 yyyy-mm-dd

4.4.Visual Analogue Scale

/

Pain Visual Analogue Score

Occasionally very slight pain

5.Speciman management system

sample collection

Collected

Volume

1 ml

Time of collection

2018-11-24 yyyy-mm-dd-hh-min.

Label Number of the sample

2100619

6.ADR/ADE management system

Date received at DCC

-- yyyymmdd

Report type

Name of this event

--

SAE start date

-- yyyymmdd

SAE stop date

-- yyyymmdd

Was this an unanticipated adverse event

Attribution to Study Drug

Outcome Type(check all that apply)

Recovery Description: (check only one)

Please provide a brief narrative of the SAE occurrence below

--

Name of the recorder

--

Data

-- yyyymmdd

Site Investigator’s signature

--

Data

-- yyyymmdd